Afuresertib + Paclitaxel for Ovarian Cancer
(PROFECTA-II Trial)

Recruiting in Palo Alto (17 mi)

+47 other locations

Overseen byHerzog Thomas, Professor

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Laekna Limited

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression. Afuresertib plus chemotherapy has demonstrated anti-tumor efficacy and an acceptable safety profile in patients with PROC in a published Phase I/II study. Therefore, the combination of afuresertib plus weekly paclitaxel could represent a clinically meaningful step forward in the clinical management of these difficult-to-treat patients with PROC.

Research Team

Herzog Thomas, Professor

Principal Investigator

University of Cincinnati Medical Center/USA/1010

Eligibility Criteria

This trial is for women aged 18+ with certain types of ovarian cancer that's resistant to platinum-based chemotherapy. They must have had 1-5 prior chemotherapies, be in good physical condition (ECOG 0-2), and not have brain metastases or other active cancers. Participants need proper organ function, no severe allergies to the drugs being tested, and agree to use contraception.

Inclusion Criteria

My digestive system can absorb medications properly.

- Must have at least one lesion that meets the definition of measurable disease by RECIST 1.1 criteria (Appendix 3).

- Patient must have a life expectancy of greater than 6 months.

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Exclusion Criteria

I have not had a severe infection related to AIDS in the last 6 months.

I have no health issues that prevent me from taking paclitaxel.

I have not had any active cancer except for skin cancer or in situ cancer in remission in the last 3 years.

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Treatment Details

Interventions

Afuresertib (AKT Inhibitor)
Paclitaxel (Microtubule Inhibitor)

Trial OverviewThe study tests Afuresertib combined with Paclitaxel against ovarian cancer that hasn't responded well to platinum treatments. Afuresertib is an AKT inhibitor which may help control cancer progression when paired with chemotherapy.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1Experimental Treatment2 Interventions

Arm 1 is afuresertib 125 mg PO QD + paclitaxel 80 mg/m2 intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 3 week cycle.

Group II: Arm 2Active Control1 Intervention

Arm 2 is paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15 of a 3 week cycle