Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Metastatic Pancreatic Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to confirm the safety and tolerability of TAK-931 in a cohort of Western participants with metastatic solid tumors and to evaluate the anti-tumor activity of TAK-931 in pa...
Detailed Description
Pancreatic Arm Now Closed. The drug being tested in this study is called TAK-931. TAK-931 blocks function of a specific protein called CDC7 kinase in the human body. TAK-931 is being tested in partic...
Eligibility Criteria
Inclusion
- Adult male or female participants aged \>=20 years (Japan) or \>=18 years (United States).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has pathologically confirmed metastatic pancreatic adenocarcinoma that has progressed after, at least, a first line of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed metastatic adenocarcinoma of the colon or rectum who have progressed to at least 2 lines of standard systemic chemotherapy for the metastatic disease, OR participants with pathologically confirmed locally advanced or metastatic sqEC that has progressed after at least a first line of standard systemic therapy for metastatic disease. First-line participants can be enrolled if a platinum doublet is contraindicated or refused by the participants, OR pathologically confirmed locally advanced or metastatic sqNSCLC that has progressed after at least 2 lines of standard systemic therapy for metastatic disease.
- For the Western safety cohort only: participants with locally advanced or metastatic solid tumor for whom no standard treatment with an established survival benefit is available or if the participant refuses other standard therapy.
- For disease-specific cohort participants: measurable disease per RECIST v. 1.1
- Left ventricular ejection fraction greater than (\>) 50% as measured by ECHO or MUGA scan within 4 weeks before receiving the first dose of study drug.
- Recovered to Grade 1 or baseline from all toxic effects of previous therapy (except alopecia or neuropathy).
- Suitable venous access for the study-required blood sampling.
- For the Western safety cohort only: willingness to undergo serial skin tissue biopsies.
- For disease-specific cohort participants: Must have an archival (banked) tumor sample or agree to have a new (fresh) tumor biopsy during the screening period. If a new tumor sample is needed, the disease should be accessible for a nonsignificant risk biopsy procedure (those occurring outside the brain, lung/mediastinum, and pancreas, or obtained with endoscopic procedures not extending beyond the stomach or bowel). For participants in the Western safety cohort, this biopsy is optional.
Exclusion
- Participants who require continuous use of proton pump inhibitors (PPIs) or histamine-2 (H2) receptor antagonists and participants who are taking PPIs within 5 days before the first dose of study drug.
- Treatment with clinically significant enzyme inducers, such as phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine, or Saint John's wort within 14 days before the first dose of study drug.
- Treatment with any systemic anticancer treatment (including investigational products) within 30 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
- History of any of the following within the last 3 months before administration of the first dose of study drug:
- Ischemic myocardial event including angina requiring therapy and artery revascularization procedures, myocardial infarction, and unstable symptomatic ischemic heart disease.
- Ischemic cerebrovascular event, including transient ischemic attack and artery, revascularization procedures.
- Significant, uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia).
- New York Heart Association Class III to IV heart failure.
- Any other cardiac condition that, in the opinion of the investigator, could pose an additional risk for participation in the study (example, pericardial effusion or restrictive cardiomyopathy).
- Baseline prolongation of the QT interval corrected for heart rate (HR) using Fridericia's formula \[QT interval corrected for heart rate using Fridericia's formula (QTcF); example, repeated demonstration of QTcF interval \>480 millisecond (ms), history of congenital long QT syndrome, or torsades de pointes\].
- Hypertension that is unstable or not controlled by medication.
- History of uncontrolled brain metastasis unless:
- Previously treated with surgery, whole-brain radiation, or stereotactic radiosurgery, and
- Stable disease (SD) for \>=30 days, without steroid use (or stable steroid dose established for \>=14 days before the first dose of TAK-931).
- Known history of human immunodeficiency virus infection.
- Known hepatitis B virus (HBV) surface antigen seropositive or detectable hepatitis C virus (HCV) infection viral load. Note: Participants who have positive HBV core antibody or HBV surface antigen antibody can be enrolled but must have an undetectable HBV viral load.
- Prior treatment with radiation therapy involving \>=25% of the hematopoietically active bone marrow within 3 months before the first dose of study drug.
- Participants with known microsatellite instability-high (MSI-H) genotype or known wild type tumor protein 53 (TP53) per local testing.
- Western Safety Cohort Only: Participants with Japanese heredity.
Key Trial Info
Start Date :
October 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03261947
Start Date
October 25 2017
End Date
August 24 2020
Last Update
September 20 2021
Active Locations (10)
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1
Sarah Cannon Research Institute Oncology Research Consortium
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute
Sarasota, Florida, United States, 34232
3
Allina Health Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55404
4
Siteman Cancer Center
St Louis, Missouri, United States, 63110