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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:December 20, 2018
End Date:November 1, 2020
Contact:Clinical Trials
Email:clinicaltrials@deciphera.com
Phone:785-830-2100

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An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics 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.


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, metastatic breast cancer.

- Recurrent ovarian cancer.

- Histologically confirmed pleural or peritoneal malignant mesothelioma

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

2. Not recovered from prior-treatment toxicities to Grade ≤1. Peripheral neuropathy of
any etiology >Grade 1.

3. Concurrent malignancy.

4. Known active CNS metastases.

5. Use of systemic corticosteroids.

6. Known retinal neovascularization, macular edema or macular degeneration.

7. History or presence of clinically relevant cardiovascular abnormalities.

8. QTcF >450 ms in males or >470 ms in females.

9. Left ventricular ejection fraction (LVEF) <50% at screening.

10. Arterial thrombotic or embolic events.

11. Venous thrombotic event.

12. Active infection ≥Grade 3.

13. Known HIV or HCV infection only if taking medications excluded per protocol, active
HBV, or active HCV infection.

14. Use of proton pump inhibitors.

15. If female, the patient is pregnant or lactating.

16. Major surgery 4 weeks prior to the first dose of study drug

17. Malabsorption syndrome or other illness which could affect oral absorption.

18. Known allergy or hypersensitivity to any component of rebastinib or any of its
excipients.

19. Any other clinically significant comorbidities
We found this trial at
2
sites
Houston, Texas 77030
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Houston, TX
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5206 Research Drive
San Antonio, Texas 78240
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San Antonio, TX
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