Trials / Recruiting

RecruitingNCT04055649

ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer

Phase II Study of ONC201 Plus Weekly Paclitaxel in Patients With Platinum-Resistant Refractory or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 62 (estimated)

Sponsor: Ira Winer · Academic / Other
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the first in its class of drugs that antagonize some specific cell receptors on cancer cells, leading to their destruction. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ONC201 and paclitaxel may work better in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel alone.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of the combination of Akt/ERK inhibitor ONC 201 (ONC201) and paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. (Part 1) II. To evaluate the objective response rate (ORR) of ONC201 in combination with paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. (Part 2) III. To evaluate progression free survival (PFS) of ONC201 in combination with weekly paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. (Part 2) SECONDARY OBJECTIVES: I. To evaluate the durability/duration of response (DOR) of ONC201 in combination with paclitaxel. II. To evaluate the safety and patient reported tolerability of ONC201 in combination with paclitaxel. (Part 2) III. To evaluate the disease control rate (DCR) of ONC201 in combination with paclitaxel. IV. To evaluate the cancer antigen-125 (CA-125) and/or human epididymis factor 4 (HE-4) response of ONC201 in combination with paclitaxel in those patients with one or both of these tumor markers upregulated. V. To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of ONC201 in combination with paclitaxel. VI. To obtain preliminary estimates of overall survival (OS) of ONC201 in combination with weekly paclitaxel. EXPLORATORY OBJECTIVES: I. To evaluate the immune response (specifically natural killer \[NK\] cell and cytokine profile) of ONC201 in combination with paclitaxel in patients with platinum refractory or resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. OUTLINE: Patients receive ONC201 orally (PO) on days 1, 8, and 15, and paclitaxel intravenously (IV) over 1 hour on days 2, 9, and 16. Cycles repeat every 28 days in the absence disease progression or unacceptable toxicity. If paclitaxel must be stopped for any reason, patients may continue on ONC201 alone. After completion of study treatment, patients are followed up for 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	Akt/ERK Inhibitor ONC201	Given orally (PO)
DRUG	Paclitaxel	Given IV
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2020-01-21
Primary completion: 2026-05-28
Completion: 2027-05-28
First posted: 2019-08-14
Last updated: 2025-06-18

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04055649. Inclusion in this directory is not an endorsement.