A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
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 patients with advanced or metastatic solid tumors.
- 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 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.
- 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.
Locations & Contacts
Status: In review
Contact: Rose Estrada
Contact: UCSF Clinical Trials
Name Not Available
Name Not Available
Trial Phase & Type
Deciphera Pharmaceuticals LLC
Secondary IDs NCI-2019-00762
Clinicaltrials.gov ID NCT03717415