A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advan… (NCT03601897) | Clinical Trial Compass
TerminatedPhase 1/2
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
Stopped: Development program terminated.
United States177 participantsStarted 2018-10-25
Plain-language summary
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients ≥18 years of age at the time of informed consent
✓. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment
✓. Part 2
✓. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2
✓. Able to provide an archival tumor tissue sample
✓. Adequate organ function and bone marrow reserve
✓. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment
✓. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures
Exclusion criteria
✕. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
✕. Not recovered from prior-treatment toxicities to Grade ≤1
✕. Peripheral neuropathy of any etiology \>Grade 1
✕. Concurrent malignancy
✕. Known active central nervous system (CNS) metastases
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: Baseline up to 2.89 years
2
Objective Response Rate (ORR) (Part 2 Expansion)
Timeframe: Baseline to PD or Death due to Any Cause (Up to 1.54 years)