Last updated on July 2016

Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial Ovarian or Cervical Cancer (AL3818-US-001)


Brief description of study

The purpose of Part 1 (Phase 1b) is to evaluate the general safety and tolerability of repeated 21-day cycles of AL3818 therapy, and to reevaluate the maximum tolerated dose (MTD). The purpose of Part 2 (Phase 2a) is to evaluate the efficacy of repeated 21-day cycles of AL3818 therapy preliminary efficacy of AL3818 in subjects with recurrent or metastatic endometrial, ovarian or cervical cancer.

Detailed Study Description

This is a Phase 1b/2a study to evaluate the safety, pharmacokinetics and efficacy of 21-day cycles of AL3818 therapy. The study is divided into two parts. Part 1 (Phase 1b) will evaluate the dose limiting toxicity (DLT) and general safety during the first 21-day cycle of Al3818 therapy and to reevaluate the MTD. It will include a sequential evaluation of 3 subjects per cohort in a 3+3 design with up to 18 subjects in total. Cohort 1 will initiate at a dose of 12 mg/day of AL3818, for cycles of 14 days of treatment followed by 7 days of rest. After three subjects have completed the first cycle of therapy without a DLT, additional cohorts may be enrolled sequentially. All subjects will be allowed continuation of therapy with repeat cycles of 21-days if they are tolerating AL3818 and have stable disease or better. After the first cohort has completed one full cycle of therapy without a DLT, two additional cohorts will be sequentially enrolled at 16 mg/day and 20 mg/day doses of AL3818 for the same 21-day cycles. Part 2 (Phase 2a) will evaluate the safety and preliminary efficacy of repeated 21-day cycles of AL3818. It will include up to 45 additional subjects with metastatic endometrial cancer, ovarian cancer refractory to platinum therapy or cervical cancer refractory to standard therapy. Each subject will receive a dose of up to 20 mg AL3818 or a maximum of the MTD from Part 1 (Phase 1b) of this study for continuous 21-Day cycles of therapy (14 days of AL3818 treatment followed by 7 days off). All subjects in Part 1 and Part 2 of this study will be permitted to continue therapy with only safety monitoring and bimonthly assessments for progression, if AL3818 is well tolerated and the subject has stable disease or better.

Clinical Study Identifier: NCT02558348

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Nita Lee, MD, MPH

University of Chicago Medical Center
Chicago, IL United States
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Theresa Werner, M.D.

Huntsman Cancer Institute, University of Utah
Salt Lake City, UT United States
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