Thanks for that Mary.

ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

Please note that information regarding clinical trials is being provided for informational purposes only. The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

Recruiting Now.

https://clinicaltrials.gov/ct2/show/NCT03230318

Purpose
This pivotal, open-label, single-arm study will evaluate the anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) by central radiology review as per RECIST v1.1 in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) whose tumors harbor FGFR2 gene fusions (by FISH performed by the central laboratory) and who received at least one prior regimen of systemic therapy. Subjects will be dosed orally once per day at 300 mg of ARQ 087 capsules.

Condition    Intervention    Phase
Intrahepatic Cholangiocarcinoma
Combined Hepatocellular and Cholangiocarcinoma
Drug: ARQ 087
Phase 3

Study Type:    Interventional
Study Design:    Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title:    A Pivotal Trial of ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma

Resource links provided by NLM:

Genetics Home Reference related topics: Crouzon syndrome Pfeiffer syndrome cholangiocarcinoma
MedlinePlus related topics: Genes and Gene Therapy
Genetic and Rare Diseases Information Center resources: Biliary Tract Cancer Bile Duct Cancer Intrahepatic Cholangiocarcinoma Crouzon Syndrome Pfeiffer Syndrome
U.S. FDA Resources

Further study details as provided by ArQule:

Primary Outcome Measures:
Anti-cancer activity of ARQ 087 by Objective Response Rate (ORR) [ Time Frame: Up to approximately 32 weeks ]
ORR will be assessed by central radiology review per RECIST version 1.1


Secondary Outcome Measures:
Safety of ARQ 087 as assessed by adverse events [ Time Frame: Up to approximately 36 weeks ]
Adverse events will be graded using NCI CTCAE guidelines, version 4.03

Anti-cancer activity of ARQ 087 by progression free survival (PFS) [ Time Frame: Up to approximately 32 weeks ]
PFS will be assessed by central radiology review per RECIST version 1.1

Anti-cancer activity of ARQ 087 by overall survival (OS) [ Time Frame: Up to approximately 36 weeks ]
OS will be calculated from the first date of receiving study drug until death

Anti-cancer activity of ARQ 087 by duration of response (DoR) [ Time Frame: Up to approximately 32 weeks ]
DoR will be assessed by central radiology review per RECIST version 1.1


Estimated Enrollment:    100
Anticipated Study Start Date:    August 2017
Estimated Study Completion Date:    March 2021
Estimated Primary Completion Date:    September 2020 (Final data collection date for primary outcome measure)
Arms    Assigned Interventions
Experimental: ARQ 087    Drug: ARQ 087
ARQ 087 will be orally administered at 300 mg once per day with or without food and is supplied as 100 mg capsules.

   Eligibility

Ages Eligible for Study:      18 Years and older   (Adult, Senior)
Sexes Eligible for Study:      All
Accepts Healthy Volunteers:      No
Criteria
Inclusion Criteria:

Signed written informed consent granted prior to initiation of any study-specific procedures
18 years of age or older
Histologically or cytologically confirmed locally advanced, inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), or metastatic iCCA or mixed histology tumors (combined hepatocellular-cholangiocarcinoma [cHCC-CCA])
FGFR2 gene fusion status confirmed by NGS or FISH testing

Test positive by FISH by the central laboratory designated by the Sponsor
Have FGFR2 gene fusion documented by a local or central laboratory using standard protocols and approved by local IRB/EC, by CLIA or other similar agency. If the FGFR2 gene fusion is identified by a laboratory other than the Sponsor's central laboratory, then archival and/or recent tissue biopsy samples or a tissue block suitable for genetic testing must be available for confirmatory testing by FISH by the Sponsor's central laboratory. If a subject has documentation from a local or central laboratory indicating that they test negative for FGFR2 gene fusion, that subject may not be enrolled in the study.
Received at least one regimen of prior systemic therapy and then experienced documented radiographic progression or was not able to tolerate prior systemic therapy.

If the subject received at least 4 cycles of systemic therapy and no measurable tumor reduction compared to the previous scan is observed, such subject can be enrolled
If the subject received immunotherapy, the documented radiographic disease progression is required
If the subject experienced disease progression within 6 months of adjuvant therapy, such therapy should be considered as the line of treatment rather than adjuvant therapy
Measurable disease by RECIST version 1.1
ECOG performance status ≤ 1
Adequate organ functions as indicated by the following laboratory values (based on screening visit values from the central laboratory).

Hematological

Hemoglobin (Hgb) ≥ 9.0 g/dL
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelet count ≥ 75 x 109/L
International normalized ratio (INR) 0.8 to upper limit of normal (ULN) or ≤ 3 for subjects receiving anticoagulant therapy such as Coumadin or heparin
Hepatic

Total bilirubin ≤ 2 x ULN
AST and ALT ≤ 3 ULN (≤ 5 x ULN for subjects with liver metastases)
Albumin ≥ 2.8 g/dL
Renal

Serum creatinine ≤ 1.5 x ULN
Creatinine clearance of ≥ 60 mL/min as estimated by the Cockcroft-Gault equation
Male or female subjects of child-producing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after the last dose of ARQ 087
Exclusion Criteria:

Systemic anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ARQ 087
Major surgery, locoregional therapy, or radiation therapy within four weeks of the first dose of ARQ 087
Previous treatment with any FGFR inhibitor (e.g., ponatinib, dovitinib, nintedanib, AZD4547, NVP-BGJ398, LY2784455, BAY1163877)

- Subjects who received less than four weeks of therapy and were unable to continue therapy due to toxicity will be allowed to participate

Unable or unwilling to swallow the complete daily dose of ARQ 087 capsules
Clinically unstable central nervous system (CNS) metastases (to be eligible, subjects must have stable disease ≥ 3 months, confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and/or have CNS metastases well controlled by low-dose steroids, anti-epileptics, or other symptom-relieving medications)
Current evidence of corneal or retinal disorder, including but not limited to bullous/band keratopathy, keratoconjunctivitis, corneal abrasion, inflammation/ulceration, confirmed by ophthalmologic examination
Concurrent uncontrolled or active hepatobiliary disorders, untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, biloma or abscess (to be eligible, the subjects have to be treated and disorders/complications should be resolved within 2 weeks prior to the first dose of ARQ 087)
History of significant cardiac disorders:

Myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of ARQ 087 (MI that occurred > 6 months prior to the first dose of ARQ 087 will be permitted)
QTcF >500 msec (males or females)
Significant gastrointestinal disorder(s) that could, in the opinion of the Investigator, interfere with the absorption, metabolism, or excretion of ARQ 087 (e.g., Crohn's disease, ulcerative colitis, extensive gastric resection)
Previous malignancy within 2 years of the first dose of ARQ 087, except curatively treated or low grade malignancies such as non-melanoma skin cancer, carcinoma in-situ of the breast, cervix, and superficial bladder tumors
Concurrent uncontrolled illness not related to cancer, including but not limited to:

Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements
Known uncontrolled human immunodeficiency virus (HIV) infection
Blood or albumin transfusion within 5 days of the blood draw being used to confirm eligibility
Pregnant or breast feeding
   Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03230318

Contacts
Contact: ArQule, Inc.    781-994-0300    ClinicalTrials@arqule.com   

Locations
United States, Georgia
Winship Cancer Institute of Emory University    Recruiting
Atlanta, Georgia, United States, 30322
Contact    781-994-0300    ClinicalTrials@arqule.com   
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania    Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    781-994-0300    ClinicalTrials@arqule.com   
United States, Tennessee
Vanderbilt-Ingram Cancer Center    Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact    781-994-0300    ClinicalTrials@arqule.com   
United States, Texas
University of Texas MD Anderson Cancer Center    Not yet recruiting
Houston, Texas, United States, 77030
Contact    781-994-0300    ClinicalTrials@arqule.com   
United States, Washington
University of Washington Medical Center    Not yet recruiting
Seattle, Washington, United States, 98109
Contact    781-994-0300    ClinicalTrials@arqule.com   
Sponsors and Collaborators
ArQule
  More Information

Responsible Party:    ArQule
ClinicalTrials.gov Identifier:    NCT03230318     History of Changes
Other Study ID Numbers:    ARQ 087-301
Study First Received:    July 24, 2017
Last Updated:    July 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:    No

Studies a U.S. FDA-regulated Drug Product:    Yes
Studies a U.S. FDA-regulated Device Product:    No
Keywords provided by ArQule:
iCCA
intrahepatic cholangiocarcinoma
FGFR2 gene fusion
ARQ 087
biliary cancer
bile duct cancer
FGFR2 gene rearrangement
liver cancer
targeted therapy
combined hepatocellular and cholangiocarcinoma
cHCC-CCA

Additional relevant MeSH terms:
Cholangiocarcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 27, 2017

Stereotactic body radiotherapy (SBRT) for locally advanced extrahepatic and intrahepatic cholangiocarcinoma.

https://www.ncbi.nlm.nih.gov/pubmed/28740893

Global health lessons from Thailand's successful liver fluke elimination campaign

https://medicalxpress.com/news/2017-07- … ssful.html

Promising therapeutics of gastrointestinal cancers in clinical trials.

https://www.ncbi.nlm.nih.gov/pubmed/28736639

Current biologics for treatment of biliary tract cancers.

https://www.ncbi.nlm.nih.gov/pubmed/28736630

Hi Marion,

Like everyone else, I too am lost for words when I heard your news and I am so very sorry to hear about this. You know that I along with everyone else will be keeping everything crossed for you and I know that you are a fighter and will fight this with everything. You know also that you have all of us in your corner fighting with you and an absolute ton of positive thoughts are coming your way.

You have helped many many people here, me included in so many ways and a ton of people around the world also with your selfless devotion to everyone and fighting for this cause. So who am I to tell you what to do, ha! But it is right that you take time away from the boards and to concentrate on you, your family and fighting this now. But as I said to you, we know what you are like and no doubt you will keep on coming back as things permit as you say. As far as scatter brain goes, I make no comments as I also do for Lainy being lost for words!

We are all here for you always Marion and you are much loved by everyone.

Huge hugs and much love to you my friend.

Gavin

Uncommon Neoplasms of the biliary tract: Radiological Findings.

https://www.ncbi.nlm.nih.gov/pubmed/28731820

Laparoscopic Pancreaticoduodenectomy: A Single Team Preliminary Experience.

https://www.ncbi.nlm.nih.gov/pubmed/28731954

Effect of contrast-enhanced ultrasound on differential diagnosis of intrahepatic cholangiocarcinoma and arterial phase enhanced hepatic inflammatory lesions.

https://www.ncbi.nlm.nih.gov/pubmed/28729778

Subsets of Inflammatory Cytokine Gene Polymorphisms are Associated with Risk of Carcinogenic Liver Fluke Opisthorchis viverrini-Associated Advanced Periductal Fibrosis and Cholangiocarcinoma.

"To our knowledge, these findings provide the first demonstration that O. viverrini infected individuals carrying several specific cytokine gene polymorphisms are susceptible to develop fibrosis and CCA."

https://www.ncbi.nlm.nih.gov/pubmed/28719954

DCK expression, a potential predictive biomarker in the adjuvant gemcitabine chemotherapy for biliary tract cancer after surgical resection: results from a phase II study.

https://www.ncbi.nlm.nih.gov/pubmed/28722661

Hi All,

Please have a look at this link here for those interested in clinical trials and searching for them etc

ClinicalTrials.gov: First in a Series of Changes to Improve Usability for Stakeholders

https://www.nlm.nih.gov/pubs/techbull/m … ility.html

Thanks,

Gavin

Thanks for that Beatriz, never give up indeed and hope that this brings hope to others also.

Hugs,

Gavin

Automated selection of aptamers against cholangiocarcinoma cells on an integrated microfluidic platform.

Sounds interesting if it ever comes to anything at some point.

https://www.ncbi.nlm.nih.gov/pubmed/28713479

Gemcitabine associated pseudocellulitis: A missed diagnosis

https://www.ncbi.nlm.nih.gov/pubmed/28714381

17

(3 replies, posted in Nutrition)

Hi Tia,

No personal experiences with Megace but know that others have and hopefully they will chip in with experiences etc about it. I know as well that there are quite a lot of postings on the site that members have made over the years and the search forum function should throw them up.

I have a few links for you from here in the UK that hopefully will give some more info for you -

http://www.macmillan.org.uk/cancerinfor … etate.aspx

http://www.cancerresearchuk.org/about-c … ol-acetate

Hugs,

Gavin

Good piece on Proton Beam Therapy for those interested, especially for UK.

Proton beam therapy is arriving in the UK: what does that mean for patients?

http://scienceblog.cancerresearchuk.org … tter_tweet

Liver cancers with stem/progenitor-cell features - a rare chemotherapy-sensitive malignancy.

https://www.ncbi.nlm.nih.gov/pubmed/28709146

Are Dominant Strictures in Primary Sclerosing Cholangitis a Risk Factor for Cholangiocarcinoma?

https://www.ncbi.nlm.nih.gov/pubmed/28706774

Coffee and some claims made the news here in the UK on the back of some study that came out claiming this, that and the next thing.  And as always with these things, massive piles of salt required instead of taking such claims with just a pinch of salt!

Here is CRUK from the UK with a piece they put out last year on coffee claims etc.

Coffee and cancer – what does the evidence say?

http://scienceblog.cancerresearchuk.org … dence-say/

Gavin

An introduction to radiotherapy: what is it, how does it work, and what’s it for?

http://scienceblog.cancerresearchuk.org … ts-it-for/

Dear Jonas,

I am so very very sorry indeed to hear of the passing of your sister Myrna. Please accept my sincerest condolences. I so wish there was something that I could say right now that would help ease the pain that you feel but I know there are no words.  You did everything that you possibly could to help. Please know that we are all here for you and my thoughts right now are with you and your family.

Thinking of you all right now.

Gavin

Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusions or Non-fusion NTRK Cancers

Please note that information regarding clinical trials is being provided for informational purposes only. The Cholangiocarcinoma Foundation does not endorse any specific clinical trial. Please discuss any questions you may have about clinical trials with your healthcare provider.

https://clinicaltrials.gov/ct2/show/NCT03215511

This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and efficacy of LOXO-195 when administered orally to patients with NTRK fusion cancers treated with prior TRK inhibition or non-fusion NTRK altered cancers regardless of prior kinase inhibitor treatment.

Condition    Intervention    Phase
Carcinoma, Non-Small-Cell Lung
Thyroid Neoplasms
Sarcoma
Colorectal Neoplasms
Salivary Gland Neoplasms
Biliary Tract Neoplasms
Brain Neoplasm, Primary
Breast Ductal Carcinoma NOS
Melanoma
Solid Tumors Cancer of Unknown Primary
Glioblastoma
Bile Duct Neoplasms
Astrocytoma
Head and Neck Squamous Cell Carcinoma
Pontine Glioma
Pancreatic Neoplasms
Ovarian Neoplasms
Carcinoma, Renal Cell
Cholangiocarcinoma
Skin Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Thyroid Cancer
GIST
Malignant Peripheral Nerve Sheath Tumors
Breast Secretory Carcinoma
Uterine Neoplasms
Drug: LOXO-195
Phase 1
Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type:    Interventional
Study Design:    Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title:    A Phase 1/ 2 Study of the TRK Inhibitor LOXO 195 in Adult Subjects With NTRK Fusion (Previously Treated) or Non-Fusion NTRK Altered Cancers

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer
Genetic and Rare Diseases Information Center resources: Glioblastoma Ovarian Cancer Neurofibroma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Secretory Breast Carcinoma Soft Tissue Sarcoma Glioma Neurofibromatosis Schwannoma Carcinoid Tumor Neuroepithelioma Fibrosarcoma Oral Cancer
U.S. FDA Resources

Further study details as provided by Loxo Oncology, Inc.:

Primary Outcome Measures:
Maximum Tolerated Dose (MTD) [ Time Frame: The first 28 days of treatment (Cycle 1) ]
For Phase 1

Recommended dose for further study [ Time Frame: The first 28 days of treatment (Cycle 1) and every cycle (28 days) for approximately 12 months (or earlier if the patient discontinues from the study) ]
For Phase 1

Best overall response of confirmed PR or CR by independent radiology review in NTRK fusion cancer patients previously treated with TRK inhibitor who have progressed [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2


Secondary Outcome Measures:
Incidence of AEs [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
For Phase 1 and Phase 2

Severity of AEs [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
For Phase 1 and Phase 2

Duration of AEs [ Time Frame: From the time of informed consent, for approximately 24 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
For Phase 1 and Phase 2

Changes in clinical laboratory results compared to baseline [ Time Frame: For approximately 24 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
For Phase 1 and Phase 2

Changes in vital signs compared to baseline [ Time Frame: For approximately 24 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose) ]
For Phase 1 and Phase 2

Best overall response of confirmed PR or CR by independent radiology review in NTRK fusion cancer patients previously treated with TRK inhibitor [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 1

Best overall response of confirmed CR or PR as determined by treating investigators using RECIST v1.1 in patients with non-fusion NTRK altered cancers or RANO in patients with primary CNS malignancies. [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 1

Best overall response of confirmed PR or CR using RECIST v1.1 or RANO criteria as appropriate in patients with non-fusion NTRK altered cancers who have demonstration of progression following or during receipt of previous anticancer therapy [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2

Best overall response of confirmed PR or CR using RECIST v1.1 or RANO criteria as appropriate in patients with documented NTRK alterations, including TRK fusions, who discontinued previous anticancer therapy including TRK inhibitors due to intolerance [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2

Duration or response (DOR) for patients with best overall response of confirmed CR or PR by an independent radiology review committee [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2

Duration or response (DOR) for patients with best overall response of confirmed CR or PR by the treating Investigator [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2

Progression-free survival (PFS) [ Time Frame: Approximately every 8 weeks for one year, then every 12 weeks while on treatment, and every 12 weeks after the last dose (for up to 2 years) in patients who have not progressed ]
For Phase 2

Overall survival (OS) [ Time Frame: Up to 24 months ]
For Phase 2

Clinical benefit rate (CBR) [ Time Frame: Up to 24 months ]
For Phase 2


Estimated Enrollment:    120
Anticipated Study Start Date:    July 2017
Estimated Study Completion Date:    December 2019
Estimated Primary Completion Date:    August 2019 (Final data collection date for primary outcome measure)
Arms    Assigned Interventions
Experimental: LOXO-195
Phase 1- Dose Escalation and determination of MTD; Multiple dose levels of LOXO-195 to be evaluated Phase 2 - Treatment with LOXO-195 at the recommended dose from Phase 1 identified for further study
Drug: LOXO-195
Oral LOXO-195

Detailed Description:
The trial will be conducted in 2 parts: dose escalation (Phase I ) and dose expansion (Phase 2) . During Phase 1, patients with advanced solid tumors are eligible if the tumor has progressed following or has not adequately responded to standard therapy, or if the patient is intolerant of, or unlikely to benefit from or refuses standard therapy. Prior TRK inhibitor therapy is required for patients harboring an NTRK fusion. During Phase 2, the same patient population as designated for Phase 1 will be treated with the dose of LOXO-195 which has been identified during phase 1 to assess specified endpoints.
  Eligibility

Ages Eligible for Study:      18 Years and older   (Adult, Senior)
Sexes Eligible for Study:      All
Accepts Healthy Volunteers:      No
Criteria
Key Inclusion Criteria:

Advanced solid tumor for which, in the opinion of the Investigator, no other standard or investigational therapy offers greater benefit.
A solid tumor diagnosis in the setting of:

a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
a documented NTRK fusion unresponsive to a prior TRK inhibitor
a documented NTRK fusion and a clinical history of intolerance to a prior TRK inhibitor
a documented NTRK alteration other than a fusion, whether or not treated with a prior TRK inhibitor
Patients will be identified via a CLIA certified (or equivalent) laboratory
Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3. If enrolled with primary CNS tumor to be assessed by RANO, Karnofsky Performance Status (KPS) ≥ 50%
Life expectancy > 4 weeks
Adequate hematologic, hepatic and renal function.
Patients with stable CNS primary tumor, brain metastases, or treated spinal cord compression are eligible if neurological symptoms and steroid use (if applicable) have been stable for 7 days prior to the first dose of LOXO-195
Ability to receive study drug therapy orally
Key Exclusion Criteria:

Required treatment with certain strong CYP3A4 inhibitors or inducers.
Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-195 or prolongation of the QT interval corrected (QTcF) > 480 msec.
Major surgery within 7 days of enrollment
Uncontrolled systemic bacterial, fungal or viral infection
Untreated/symptomatic leptomeningeal carcinomatosis, spinal cord compression, primary CNS metastases or primary CNS malignancy.
Pregnancy or lactation.
   Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03215511

Contacts
Contact: Patient Advocacy    1-855-NTRK-123    clinicaltrials@loxooncology.com   

Locations
United States, New York
Memorial Sloan Kettering Cancer Center    Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Loxo Oncology, Inc.
Investigators
Study Director:    Nora Ku, MD    Senior Medical Director, Loxo Oncology
  More Information

Responsible Party:    Loxo Oncology, Inc.
ClinicalTrials.gov Identifier:    NCT03215511     History of Changes
Other Study ID Numbers:    LOXO-EXT-17005
Study First Received:    June 30, 2017
Last Updated:    July 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:    No

Studies a U.S. FDA-regulated Drug Product:    Yes
Studies a U.S. FDA-regulated Device Product:    No
Keywords provided by Loxo Oncology, Inc.:
NTRK Fusion Positive
LOXO-195
Loxo
TRK
TRK Fusion
NTRK1
NTRK2
NTRK3
TRKA
TRKB
TRKC
NTRK
ETV6
fusion
tumors
CNS tumors
solid tumors
central nervous system tumors
advanced cancer
primary CNS tumor
Advanced CNS tumor
Metastatic CNS tumor
NTRK1 fusion
NTRK2 fusion
NTRK3 fusion
ETV6-NTRK3
ETV6 fusion
Metastatic cancer
Cancer of Unknown Primary Site

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Melanoma
Carcinoma, Squamous Cell
Glioblastoma
Thyroid Diseases
Astrocytoma
Thyroid Neoplasms
Cholangiocarcinoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Brain Neoplasms
Carcinoma, Ductal
Carcinoma, Renal Cell
Nerve Sheath Neoplasms
Neurofibroma
Neurilemmoma
Neurofibrosarcoma
Uterine Neoplasms
Biliary Tract Neoplasms
Thoracic Neoplasms
Intestinal Neoplasms
Respiratory Tract Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Bile Duct Neoplasms

ClinicalTrials.gov processed this record on July 13, 2017

Benefit of everolimus in treatment of an intrahepatic cholangiocarcinoma patient with a PIK3CA mutation.

https://www.ncbi.nlm.nih.gov/pubmed/28694672