A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors
Stopped early · Phase 1/Phase 2
Conditions studied: Locally Advanced or Metastatic Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT03601897
- Run by
- Deciphera Pharmaceuticals, LLC
- People needed
- 177
- Starts
- 2018-10-25
- Expected to finish
- 2022-05-23
- Last updated by the study team
- 2024-12-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients ≥18 years of age at the time of informed consent
- Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment
- Part 2
- Triple-negative and Stage IV inflammatory breast cancer
- Recurrent ovarian cancer
- Recurrent, metastatic or high-risk endometrial cancer
- Advanced (stage III or IV), or recurrent gynecological carcinosarcoma
- Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor [MMMT] allowed
- Eastern Cooperative Oncology Group Performance Status (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
You may not qualify if…
- Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
- Not recovered from prior-treatment toxicities to Grade ≤1
- Peripheral neuropathy of any etiology >Grade 1
- Concurrent malignancy
- Known active central nervous system (CNS) metastases
- Use of systemic corticosteroids
- Known retinal neovascularization, macular edema or macular degeneration
- History or presence of clinically relevant cardiovascular abnormalities
- QT interval corrected by Fridericia's formula (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
- Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (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
Where it is running
- University of Alabama Comprehensive Cancer Center — Birmingham, Alabama, United States
- University of Colorado Denver- Anschutz Medical Center — Aurora, Colorado, United States
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
- The University of Kansas Clinical Research Center — Kansas City, Kansas, United States
- Dana-Farber — Boston, Massachusetts, United States
- Northwell Health/Monter Cancer Center — Lake Success, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Women & Infants Hospital — Providence, Rhode Island, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Oncology Consultants- Texas Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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