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.

Primary Outcome Measures

  • Adverse Events (Part 1 and Part 2) [Time Frame: Approximately 24 months]
  • Objective response rate (ORR) (Part 2) [Time Frame: Approximately 24 months]

Secondary Outcome Measures

  • Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the Cmax
  • Area under the concentration-time curve (AUC) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the AUC
  • Progression-free-survival (PFS) [ Time Frame: Approximately 24 months ]
    Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause
  • Time to progression (TTP) [ Time Frame: Approximately 24 months ]
    Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease
  • Duration of response (DOR) [ Time Frame: Approximately 24 months ]
    Measure of time from PR, CR to disease progression or death due to any cause
  • Overall survival (OS) [ Time Frame: Approximately 24 months ]
    Measure of overall survival
Inclusion Criteria
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)

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 14 days or 5× the half-life (within 28 days for biologics) prior to the first dose.

Not recovered from prior-treatment toxicities to 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.

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

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: November 30th, 2018.

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Last update: January 19, 2018. 04:57:31 pm.