A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), 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 (AL3818)

  • STATUS
    Recruiting
  • End date
    Dec 11, 2024
  • participants needed
    270
  • sponsor
    Advenchen Laboratories, LLC
Updated on 11 October 2022
paclitaxel
renal function
cancer
total bilirubin
tyrosine
serum pregnancy test
carcinoma
squamous cell carcinoma
maintenance therapy
international normalized ratio
doxorubicin
neutrophil count
carboplatin
adenosquamous carcinoma
aptt
cancer chemotherapy
adenocarcinoma
ovarian cancer
renal function tests
liposomal doxorubicin
platinum-based chemotherapy
paclitaxel carboplatin
cervical carcinoma
topotecan
metastatic cervical cancer
undifferentiated carcinoma
endometrioid adenocarcinoma
clear cell adenocarcinoma
serous adenocarcinoma
endometrioid carcinoma
carboplatin/paclitaxel
peritoneal cancer
serous cystadenocarcinoma
cancer of the ovary
al3818

Summary

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.

Description

This trial is a Phase 1b/2a/3 trial designed to evaluate the safety and efficacy of adding oral AL3818(Anlotinib, INN: Catequentinib) to standard platinum-based chemotherapy concurrently and continued as a maintenance therapy for up to 12 months, in subjects with recurrent or metastatic endometrial, ovarian, fallopian, primary peritoneal, or cervical carcinoma. AL3818 is a novel small molecule dual receptor tyrosine kinase inhibitor, which shows highly selective inhibition of fibroblast growth factor receptor (FGFr) and vascular endothelial growth factor receptor (VEGFR). Preclinical studies of this agent in mouse models, including various cancer xenografts, have demonstrated that treatment of tumor-bearing mice with AL3818 induces tumor reductions.

Phase 1 & 2: This study is 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). Phase 1 / Part 1 is now complete. Part 2-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. Phase I is closed and Phase 2 is closed.

Phase 3: This study is currently a Phase III, multi-center, randomized trial with active control designed to evaluate the efficacy and safety of AL3818 8 mg plus background treatment (Active Arm) vs background treatment alone (Control Arm), where three background treatments, weekly paclitaxel, pegylated liposomal doxorubicin (PLD), and topotecan are utilized. Oral AL3818 8 mg may be given concurrently with background treatment or alone if the background treatment must be discontinued due to its toxicity for up to 24 cycles of therapy, in subjects with recurrent or metastatic platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Phase 3 is open.

Details
Condition Endometrial Carcinoma, Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Cervical Carcinoma
Treatment Topotecan, carboplatin, Paclitaxel, Pegylated Liposomal Doxorubicin (PLD), AL3818
Clinical Study IdentifierNCT02584478
SponsorAdvenchen Laboratories, LLC
Last Modified on11 October 2022

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