A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Locally Advanced or Metastatic Solid Tumor

In brief

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic solid tumors.

Key facts

Study ID

NCT03717415

Run by

Deciphera Pharmaceuticals, LLC

People needed

70

Starts

2019-01-02

Expected to finish

2022-11-01

Last updated by the study team

2024-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥18 years of age at the time of informed consent.
• Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment.
• Part 2 (Dose Expansion)
• Previously treated, triple-negative breast cancer.
• Recurrent platinum-sensitive ovarian cancer.
• Histologically confirmed pleural or peritoneal malignant mesothelioma.
• ECOG performance status 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.

You may not qualify if…

• Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose.
• Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
• Peripheral neuropathy of any etiology >Grade 1.
• Concurrent malignancy.
• Known active CNS metastases.
• Use of systemic corticosteroids.
• Known retinal neovascularization, macular edema or macular degeneration.
• History or presence of clinically relevant cardiovascular abnormalities.
• QTcF >450 ms in males or >470 ms in females.
• Left ventricular ejection fraction (LVEF) <50% at screening.
• Arterial thrombotic or embolic events.
• Symptomatic venous thrombotic event.
• Active infection ≥Grade 3.
• Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
• Use of proton pump inhibitors.
• If female, the patient is pregnant or lactating.
• Major surgery 4 weeks prior to the first dose of study drug.
• Malabsorption syndrome or other illness which could affect oral absorption.
• Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
• Any other clinically significant comorbidities.

Where it is running

• University of California San Francisco (UCSF) — San Francisco, California, United States
• UCLA Medical Center — Santa Monica, California, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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