Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.

Phase 1 Completed 32 enrolled Kazia Therapeutics Limited

NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil to women with persistent or recurrent ovarian cancer, Fallopian tube cancer or primary peritoneal cancer. The study also aims to determine the maximum tolerated dose of Cantrixil in these patients when administered as a monotherapy or a combination therapy.

Timeline

Start: 2016-12-05
Primary completion: 2020-03-24
Completion: 2020-03-24

Outcome

Met primary endpoint

release “study (NCT02903771) conducted at sites in the USA and Australia confirmed that the Phase I study met its primary endpoints” vivesto.com ↗

Publications

Results Coward JI, Barve MA, Kichenadasse G, Moore KN, Harnett PR, Berg D, Garner JS, Dizon DS. Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results. Cancers (Basel). 2021 Jun 26;13(13):3196. doi: 10.3390/cancers13133196.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cantrixil	Small molecule	0.06 mg/kg	Other
Subject	Cantrixil	Small molecule	0.12 mg/kg	Other
Subject	Cantrixil	Small molecule	0.24 mg/kg	Other
Subject	Cantrixil	Small molecule	0.6 mg/kg	Other
Subject	Cantrixil	Small molecule	1.25 mg/kg	Other
Subject	Cantrixil	Small molecule	2.5 mg/kg	Other
Subject	Cantrixil	Small molecule	5 mg/kg	Other
Subject	Cantrixil	Small molecule	10 mg/kg	Other
Subject	Cantrixil	Small molecule	20 mg/kg	Other