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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
AL3818 Trial 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.Check my eligibility
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.See study design
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.
AL3818 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
My uterine cancer diagnosis requires further treatment with platinum-based chemotherapy.
Select...
My cervical cancer cannot be cured with surgery or radiation.
Select...
I can take pills by mouth.
Select...
I am able to get out of my bed or chair and move around.
AL3818 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
Toxicity as assessed by CTCAE (v4.3) - Part 2 (Phase 2a)
AL3818 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
~5380
Pegylated Liposomal Doxorubicin (PLD)
2016
Completed Phase 2
~90
Topotecan
2017
Completed Phase 3
~2400
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Advenchen Laboratories, LLCLead Sponsor
4 Previous Clinical Trials
393 Total Patients Enrolled
Clinical DirectorStudy DirectorAdvenchen Laboratories, LLC
17 Previous Clinical Trials
4,201 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My health is stable enough to participate in a study.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.I have been diagnosed with HIV.I haven't had stomach bleeding or ulcers in the last 3 months.I have a history of serious blood vessel problems.I have not had an abdominal abscess in the last 3 months.I have had pancreatitis and kidney problems in the past.I have not coughed up blood in the last 3 months.I have recently undergone chemotherapy, immunotherapy, or radiotherapy.I have high blood pressure that isn't well-managed.I have risk factors for or a history of Torsades de pointes.I have a history of swallowing problems or chronic gut issues.I am a woman aged 18 or older.My ovarian cancer has returned or spread and reacts differently to platinum-based treatments.I am on warfarin for blood thinning.My uterine cancer diagnosis requires further treatment with platinum-based chemotherapy.My cervical cancer cannot be cured with surgery or radiation.I can take pills by mouth.I am able to get out of my bed or chair and move around.I have liver disease or hepatitis with cirrhosis or liver problems.I am not taking medication that strongly affects liver enzymes.I am currently experiencing active bleeding or have a condition that increases my risk of bleeding.I am currently on antibiotics for a bacterial infection.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I have a serious wound, ulcer, or bone fracture that won't heal.My cancer can be measured and was confirmed by a scan within the last 28 days.I agree to use birth control if I can become pregnant.I have a history or signs of brain or spinal cord disease.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3 -Active Treatment Arm
- Group 2: Phase 1b: AL3818 plus carboplatin and paclitaxel
- Group 3: Phase 2a: AL3818 plus carboplatin and paclitaxel
- Group 4: Phase 3-Control Treatment Arm
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study have a large geographical footprint?
"At the time of this writing, the trial is being conducted out of University of California Los Angeles Health, Washington University, and AHN West Penn Hospital. Additionally, there are 8 other sites spread across the country."
Answered by AI
Have there been other tests similar to this one in the past?
"Alfacell first sponsored a study on AL3818 in 1997 and, after a positive response which included 300 patients, AL3818 received its Phase 3 drug approval. Currently, 1618 live trials for AL3818 are taking place in 86 countries and 3700 cities."
Answered by AI
Are there comparable treatments to AL3818?
"AL3818 was first introduced in 1997 via a clinical trial at Spectrum Health Hospital - Butterworth Campus. There have been a total of 2196 completed studies since then. Currently, 1618 trials are ongoing, with a large concentration taking place in Los Angeles, California."
Answered by AI
Has AL3818 completed the necessary regulatory steps for public sale?
"There is already some data to suggest that AL3818 is effective and multiple rounds of safety testing have been conducted, so it received a score of 3."
Answered by AI
What is the goal that researchers are hoping to achieve with this experiment?
"According to the trial's sponsor, Advenchen Laboratories, the primary objective of the study – which will be assessed over the course of 12 months – is to Measure the Progression Free Survival in Phase 3. Additionally, the study will be measuring secondary outcomes including the Number of Participants with Adverse Events as a measure of safety and toxicity in Phase 1b, which is defined as the Incidence and severity of treatment-related adverse events reported and their relationship to the medication being trialled. Another secondary outcome is Overall Survival in Phase 3, which is defined as the efficacy between the Active Arm and Control Arm as measured by the endpoints of"
Answered by AI
What maladies does AL3818 usually alleviate?
"AL3818 is most often used to treat acute myelocytic leukemia, but can also be useful for treating neuroblastoma, sarcoma, and other malignant neoplasms."
Answered by AI
Is it currently possible to sign up for this clinical trial?
"The trial, as specified on clinicaltrials.gov, is presently in the process of recruiting individuals for the study. The first posting was on December first, 2015, with the most recent edit on September 26th, 2022."
Answered by AI
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