A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma

NCT02584478 Phase 3 UNKNOWN

This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy concurrently in Subjects with Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma.

Details

Lead sponsor	Advenchen Laboratories, LLC
Phase	Phase 3
Status	UNKNOWN
Enrolment	294
Start date	2015-12
Completion	2024-12

Conditions

• Endometrial Carcinoma
• Ovarian Carcinoma
• Fallopian Tube Carcinoma
• Primary Peritoneal Carcinoma
• Cervical Carcinoma

Interventions

• AL3818
• Paclitaxel
• Pegylated Liposomal Doxorubicin (PLD)
• Topotecan
• Topotecan
• Carboplatin
• Paclitaxel
• AL3818

Primary outcomes

• Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b) — Cycle 1 (21-days)
  Determine the Recommended Phase 2 Dose (RP2D) via evaluation of dose limiting toxicity (DLT) events.
• Objective Response Rates (ORR) - Part 2 (Phase 2a) — 12 months
  Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST, v1.1) criteria after three complete 21-day cycles in the first 9 cycles then once every 6 cycles for up to 12 months. ORR is measured by the number of complete (CR) and partial responses (PR)
• Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3) — 12 Months
  To evaluate the efficacy between the Active Arm (AL3818 in combination with background chemotherapy) and Control Arm (background chemotherapy alone arm) as measured by the primary endpoint of Progression Free Survival (PFS).

Countries

United States, China, Italy, South Korea, Spain, United Kingdom