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

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Deciphera Pharmaceuticals, LLC

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

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

See 7 more

Treatment Details

Interventions

Paclitaxel (Mitotic Inhibitor)
Rebastinib (Tyrosine Kinase Inhibitor)

Participant Groups

11Treatment groups

Experimental Treatment

Group I: Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group II: Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group III: Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group IV: Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 repeated 28-day cycles.

Group V: Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group VI: Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group VII: Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group VIII: Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group IX: Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group X: Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m\^2 on days 1, 8, and 15 of repeated 28-day cycles.

Group XI: Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2Experimental Treatment2 Interventions

Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m\^2) on days 1, 8, and 15 of repeated 28-day cycles.

Paclitaxel is already approved in Canada for the following indications: