A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel 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 Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601897
• Other study ID #: DCC-2036-01-003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 25, 2018
• Est. completion date: May 23, 2022

Study information

• Verified date: September 2023
• 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 paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 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 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment.

3. 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

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 28 days or 5× the half-life prior to the first dose.

2. Not recovered from prior-treatment toxicities to Grade =1.

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. Venous thrombotic event.

13. Active infection =Grade 3.

14. 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
• Paclitaxel
Paclitaxel administered by IV infusion at 80 mg/m2

Locations

Country	Name	City	State
United States	University of Colorado Denver- Anschutz Medical Center	Aurora	Colorado
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Dana-Farber	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Ohio State University Wexner Medical Center	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Oncology Consultants- Texas Medical Center	Houston	Texas
United States	The University of Kansas Clinical Research Center	Kansas City	Kansas
United States	Northwell Health/Monter Cancer Center	Lake Success	New York
United States	Sarah Cannon Research Institute	Nashville	Tennessee
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

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 36 months
Primary	Objective response rate (ORR) (Part 2)		Approximately 36 months
Secondary	Maximum observed concentration (Cmax) of rebastinib	Measure the Cmax	Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)
Secondary	Area under the concentration-time curve (AUC) of rebastinib	Measure the AUC	Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 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 36 months
Secondary	Time to progression (TTP)	Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease	Approximately 36 months
Secondary	Duration of response (DOR)	Measure of time from PR, CR to disease progression or death due to any cause	Approximately 36 months
Secondary	Overall survival (OS)	Measure of overall survival	Approximately 36 months