Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female patients ≥18 years of age at the time of informed consent. 2. Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which carboplatin is considered appropriate treatment. 3. Part 2 (Dose Expansion) - Previously treated, triple-negative breast cancer. - Recurrent platinum-sensitive ovarian cancer. - Histologically confirmed pleural or peritoneal malignant mesothelioma. 4. ECOG performance status of ≤2. 5. Able to provide an archival tumor tissue sample. 6. Adequate organ function and bone marrow reserve. 7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment. 8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.

Exclusion Criteria

  1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life (whichever is shorter) prior to the first dose. 2. Not recovered from prior-treatment toxicities to Grade ≤1 or baseline. 3. Peripheral neuropathy of any etiology >Grade 1. 4. Concurrent malignancy. 5. Known active CNS metastases. 6. Use of systemic corticosteroids. 7. Known retinal neovascularization, macular edema or macular degeneration. 8. History or presence of clinically relevant cardiovascular abnormalities. 9. QTcF >450 ms in males or >470 ms in females. 10. Left ventricular ejection fraction (LVEF) <50% at screening. 11. Arterial thrombotic or embolic events. 12. Symptomatic venous thrombotic event. 13. Active infection ≥Grade 3. 14. Known HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection. 15. Use of proton pump inhibitors. 16. If female, the patient is pregnant or lactating. 17. Major surgery 4 weeks prior to the first dose of study drug. 18. Malabsorption syndrome or other illness which could affect oral absorption. 19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients. 20. Any other clinically significant comorbidities.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 		Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) dosed in 21-day cycles in combination with carboplatin administered by IV infusion at either AUC5 or AUC6 once every 3 weeks
  • Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other names:
    • DCC-2036
  • Drug: Carboplatin
    Carboplatin administered by IV infusion at AUC5 or AUC6
Experimental
Part 2 		Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with carboplatin Triple-negative breast cancer Platinum-sensitive Ovarian cancer Mesothelioma
  • Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other names:
    • DCC-2036
  • Drug: Carboplatin
    Carboplatin administered by IV infusion at AUC5 or AUC6

More Details

Status
Completed
Sponsor
Deciphera Pharmaceuticals LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.