A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:September 19, 2018
End Date:July 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 Paclitaxel 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 paclitaxel 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 Histologically confirmed diagnosis of a locally advanced or metastatic solid
tumor for which paclitaxel or nab-paclitaxel are considered appropriate treatment.

3. Part 2

- Previously treated, metastatic breast cancer.

- Recurrent ovarian cancer.

- Recurrent, metastatic or high-risk endometrial cancer.

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. 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
6
sites
Philadelphia, Pennsylvania 19111
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Birmingham, AL
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Houston, Texas 77030
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Houston, TX
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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