Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT04814875 : Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Female Reproductive<br/>System CancersCancer LocationFemale Reproductive
System Cancers

Systemic therapy | Female reproductive organsFallopian tube,Ovary,Peritoneal

Trial Overview Read MoreRead more

This phase Ib/IIa trial is evaluating the safety and effectiveness of a drug designed to enhance the effectiveness of other treatments (ATX-101) when combined with platinum-based chemotherapy (carboplatin/pegylated liposomal doxorubicin [ACD]) in people with platinum-sensitive, recurrent ovarian, fallopian tube or primary peritoneal cancer.
 

This trial is treating patients with platinum-sensitive, recurrent ovarian, fallopian tube or primary peritoneal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase 1b/2a Study Investigating ATX-101 in Combination With Platinum-based Chemotherapy in Platinum-sensitive, Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Commercial Sponsor

THERAPIM PTY LTD

Summary

This study has two parts. Part 1 is investigating the safety of the combination of ATX-101 with carboplatin/pegylated liposomal doxorubicin (ACD). ATX-101 will be administered intravenously in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design. In the case where 20 mg/m² is not tolerated, the dose can be de-escalated to 15 mg/m². Pegylated liposomal doxorubicin (30 mg/m²) will be administered intravenously on Day 1 of each 28-day cycle; carboplatin (AUC5) will be administered intravenously on Day 1 of each cycle. Part 2 will be further investigating the efficacy and safety of this combination. In this part, ATX-101 will be administered at the dose defined in part 1 of the study.

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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