A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System (NCT03648372) | Clinical Trial Compass
TerminatedPhase 1/2
A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System
Stopped: Enrolment Challenges
United States109 participantsStarted 2018-10-01
Plain-language summary
This study is in 2 parts.
The main aims of the 1st part of the study are to check if people with advanced solid tumors or cancers in the immune system (lymphomas) have side effects from TAK-981, and to check how much TAK-981 they can receive without getting side effects from it.
The main aims of the 2nd part of the study are to learn if the condition of people with specific cancers improves after treatment with TAK-981. Another aim is to check for side effects from TAK-981.
In the 1st part of the study, participants will receive TAK-981. In the 2nd part of the study, participants with specific tumor types will receive TAK-981 at the recommended phase 2 dose determined during the 1st part of the study.
In both parts of the study, participants can receive TAK-981 for up to 1 year or longer if their condition stays improved. Participants will receive TAK-981 through vein.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Adult male or female participants ≥18 years old.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
✓. Population for Phase 1 dose escalation:
✓. Population for Phase 2 dose expansion cohorts:
✓. In Phase 2 only, have at least 1 radiologically measurable lesion based on RECIST v1.1 for participants with solid tumors or Lugano criteria for lymphoma. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. In Phase 2 stage 1, willing to consent to mandatory pretreatment and on-treatment tumor biopsy.
✓. Is willing to provide archival tumor tissue sample, if available.
✓. Adequate bone marrow reserve and renal and hepatic function.
Exclusion criteria
✕. Phase 1 dose escalation and Phase 2 cancer treatment expansion cohorts:
What they're measuring
1
Phase 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
2
Phase 1: Number of Participants With Grade 3 or Higher TEAEs
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
3
Phase 1: Duration of TEAEs
Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 35.3 months)
4
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Timeframe: Cycle 1 (Cycle length is equal to [=] 21 days)
5
Phase 2: Overall Response Rate (ORR)
Timeframe: From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 11.2 months)
✕. History of any of the following ≤6 months before first dose: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, severe noncompensated hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias of \>Grade 2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (example, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed.
✕. Baseline prolongation of the QT interval with Fridericia correction method (QTcF) (example, repeated demonstration of QTcF interval \>480 milliseconds (ms), history of congenital long QT syndrome, or torsades de pointes).
✕. Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events (AEs) or has compromised ability to provide written informed consent.
✕. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse.
✕. History of autoimmune disease requiring systemic immunosuppressive therapy.
✕. History of immune-related AEs related to treatment with immune checkpoint inhibitors that required treatment discontinuation.
✕. History of noninfectious pneumonitis that required steroids or a history of interstitial lung disease.