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Dual Receptor Tyrosine Kinase Inhibitor

AL3818 + Chemotherapy for Gynecologic Cancers (AL3818 Trial)

Phase 3

Waitlist Available

Research Sponsored by Advenchen Laboratories, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female ≥ 18 years of age

Histologically proven diagnosis of ovarian cancer: Platinum-sensitive or platinum-resistant recurrent or metastatic ovarian, fallopian, or primary peritoneal cancer

Must not have

Women who are pregnant or nursing

Other invasive malignancies within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it's safe and effective in treating various types of gynecologic cancers.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include risks associated with kinase inhibitors such as high blood pressure, bleeding events, heart issues like arrhythmias or failure, liver problems, gastrointestinal complications like ulcers or obstruction, kidney damage including proteinuria (protein in urine), and general side effects from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged 18 or older.

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My ovarian cancer has returned or spread and reacts differently to platinum-based treatments.

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My uterine cancer diagnosis requires further treatment with platinum-based chemotherapy.

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My cervical cancer cannot be cured with surgery or radiation.

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I can take pills by mouth.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing.

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

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I have a serious heart condition.

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I have been diagnosed with HIV.

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I haven't had stomach bleeding or ulcers in the last 3 months.

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I have a history of serious blood vessel problems.

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I have had pancreatitis and kidney problems in the past.

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I have high blood pressure that isn't well-managed.

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I have risk factors for or a history of Torsades de pointes.

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I have a history of swallowing problems or chronic gut issues.

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I am on warfarin for blood thinning.

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I have liver disease or hepatitis with cirrhosis or liver problems.

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I am not taking medication that strongly affects liver enzymes.

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I am currently experiencing active bleeding or have a condition that increases my risk of bleeding.

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I am currently on antibiotics for a bacterial infection.

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I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

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I have a serious wound, ulcer, or bone fracture that won't heal.

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I have a history or signs of brain or spinal cord disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure the Progression Free Survival (PFS)- Part 3 ( Phase 3)

Objective Response Rates (ORR) - Part 2 (Phase 2a)

Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b)

Secondary study objectives

Clinical Benefit Rate (CBR) - Part 2 (Phase 2a)

Duration Of Response - Part 3 ( Phase 3)

Number of Participants with Adverse Events as a measure of safety and toxicity of 21-Day cycles of AL3818 as measured by incidence and severity of treatment-related adverse events (TRAE) - Part 1 (Phase 1b)

+4 more

Other study objectives

Toxicity as assessed by CTCAE (v4.3) - Part 2 (Phase 2a)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Pegylated Liposomal Doxorubicin (PLD)

2016

Completed Phase 2

~90