AL3818 + Chemotherapy for Gynecologic Cancers
(AL3818 Trial)

Recruiting in Palo Alto (17 mi)

+40 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Advenchen Laboratories, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Director

Principal Investigator

Advenchen Laboratories, LLC

Eligibility Criteria

This trial is for women over 18 with recurrent or metastatic endometrial, ovarian, fallopian tube, primary peritoneal or cervical cancer. They must have had at least one prior line of platinum-based chemotherapy and be able to take oral medication. Adequate organ function and a life expectancy of more than 3 months are required. Participants must not be pregnant and agree to use contraception.

Inclusion Criteria

My health is stable enough to participate in a study.

Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures

Provide written informed consent and authorization permitting release of Protected Health Information

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Exclusion Criteria

I am not pregnant or nursing.

I have not had any other cancer besides this one in the last 5 years.

I have a serious heart condition.

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Treatment Details

Interventions

AL3818 (Dual Receptor Tyrosine Kinase Inhibitor)
Carboplatin (Alkylating agents)
Paclitaxel (Plant alkaloids)
Pegylated Liposomal Doxorubicin (PLD) (Anti-tumor antibiotic)
Topotecan (Alkylating agents)

Trial OverviewThe trial tests the addition of AL3818 (Anlotinib), an oral Dual Receptor Tyrosine Kinase Inhibitor, to standard platinum-based chemotherapy in women with certain types of advanced gynecological cancers. It aims to assess safety and effectiveness across multiple phases including Phase 1b/2a/3.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Phase 3-Control Treatment ArmExperimental Treatment3 Interventions

Control Treatment Arm: Background chemotherapy treatment alone. Platinum resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer subjects will be enrolled into one of the following three background chemotherapy groups: * Weekly paclitaxel (default choice; if the subject is ineligible for paclitaxel, the investigator will select from PLD or topotecan) * Pegylated liposomal doxorubicin (PLD) * Topotecan

Group II: Phase 3 -Active Treatment ArmExperimental Treatment4 Interventions

Phase 3: AL3818 8 mg once daily in combination with one background chemotherapy in 21-day cycles. Platinum resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer subjects will be enrolled into one of the following three background chemotherapy groups: * Weekly paclitaxel (default choice; if the subject is ineligible for paclitaxel, the investigator will select from PLD or topotecan) * Pegylated liposomal doxorubicin (PLD) * Topotecan

Group III: Phase 2a: AL3818 plus carboplatin and paclitaxelExperimental Treatment3 Interventions

Phase 2a: subjects will receive chemotherapy and oral AL3818 for 6 cycles (18 weeks, 21-day cycles of treatment) followed by continuous maintenance treatment of oral AL3818 for up to 12 months. Subjects will be administered carboplatin (AUC 5/6 over 30 minutes) and paclitaxel (175mg/m2 over 3 hours) intravenously on Day 1. AL3818 is orally administered daily starting on Day 8 until Day 21 (14 days) at the RP2D found in Phase 1b.

Group IV: Phase 1b: AL3818 plus carboplatin and paclitaxelExperimental Treatment3 Interventions

Phase 1b: Sequential deescalating dosing evaluation to determine the recommended Phase II dose (RP2D). For 21-day treatment cycles, cohort 1 (3 subjects) will be administered carboplatin (AUC 5/6 over 30 minutes) and paclitaxel (175mg/m2 over 3 hours) intravenously on Day 1. AL3818 is orally administered daily starting on Day 8 until Day 21 (14 days) at an initial dose of 12 mg/day.