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AL3818, Dual Receptor Tyrosine Kinase Inhibitor Ovarian, Fallopian, Primary Peritoneal Cervical Ca

Krishnansu Tewari


A Study On:

  • Other Female Genital
  • Cervix
  • Ovary

Status:

Eligibility

Adult

Interested in joining this trial?

Official Title

A Phase I/IIa/III Evaluation of the Safety and Efficacy of Adding AL3818, 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

Details

This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months.

This study will be divided into two parts. The objective of Part 1 is the evaluation of the safety and tolerability of adding oral AL3818 to standard carboplatin plus paclitaxel chemotherapy for a cycle of 21 days to determine the recommended Phase II dose (RP2D). The objective of Part 2 is evaluation of preliminary efficacy and the safety of adding oral AL3818 at the RP2D determined in Part 1 to carboplatin and paclitaxel chemotherapy for 6 cycles. Continuous maintenance mono therapy with 14 days on and 7 days off regimen at the RP2D will be conducted up to 12 months and is extendable beyond until disease progression.


Eligibility

You can join if...

Inclusion Criteria:
-Female >18 years of age
-Have measurable disease defined by RECIST 1.1 confirmed by CT or MRI scan within 28 days of enrollment.
-Life expectancy of >3 months at the time of enrollment.

Exclusion Criteria:
-Known history of human immunodeficiency virus infection (HIV).
-Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to C1D1 (a major surgical procedure is defined as requiring general anesthesia).
-Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.

Get in touch with our study team