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

Locally Advanced or Metastatic Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717415
• Other study ID #: DCC-2036-01-004
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2024
• Source: Deciphera Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• rebastinib
25 mg tablets or 75 mg tablets
• Carboplatin
Carboplatin administered by IV infusion at AUC5 or AUC6

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	NEXT Oncology	San Antonio	Texas
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	UCLA Medical Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Deciphera Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events (Part 1 and Part 2)		Approximately 24 months
Primary	Objective response rate (ORR) (Part 2)		Approximately 24 months
Secondary	Maximum observed concentration (Cmax) of rebastinib	Measure the Cmax	Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days)
Secondary	Area under the concentration-time curve (AUC) of rebastinib	Measure the AUC	Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days)
Secondary	Progression-free-survival (PFS)	Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause	Approximately 24 months
Secondary	Time to progression (TTP)	Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease	Approximately 24 months
Secondary	Duration of response (DOR)	Measure of time from first PR, CR to disease progression or death due to any cause	Approximately 24 months
Secondary	Overall survival (OS)	Measure of the interval between Cycle 1 Day 1 until date of death from any cause	Approximately 24 months