Onconova Therapeutics, Inc.
This study will assess the safety and efficacy of increasing doses of narazaciclib (ON 123300) in combination with the standard daily dose (2.5mg) of letrozole in patients with Recurrent Metastatic Low-grade Endometrioid Endometrial Cancer and other Gynecologic Malignancies.
Endometrioid Endometrial Cancer
Narazaciclib
Letrozole 2.5mg
Phase 1
Phase 2
This is a phase 1/2a, open-label, multicenter study to evaluate the safety, tolerability and efficacy of escalating doses of narazaciclib (ON 123300) in combination with letrozole for patients with recurrent metastatic low-grade endometrioid endometrial cancer and other Gynecologic Malignancies. Pharmacokinetics and pharmacodynamics will also be assessed. In Phase 1, eligible patients will be enrolled to escalating dose cohorts. Cohorts will receive escalating doses of oral narazaciclib starting at 160 mg orally, once daily, in combination with letrozole 2.5 mg orally, once daily, in 28-day cycles in a typical 3 + 3 design. The dose of narazaciclib will be increased in 40 mg/day increments from cohort to cohort until the maximum tolerated dose (MTD) and/or the minimal biologically effective dose (MBED) of narazaciclib orally, once daily, in combination with letrozole 2.5 mg orally, once daily, is reached and the RP2D of the combination is established. Three to 6 patients will be enrolled per dose cohort in phase 1. In Phase 2a, narazaciclib and letrozole at the RP2D established in Phase 1 will be administered to approximately 30 eligible patients with documented recurrent metastatic LGEEC for 28-day cycles. Treatment will continue until disease progression, patient withdrawal, or unacceptable drug-related toxicity.
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center Phase 1/2a Study of Narazaciclib (ON 123300) in Combination With Letrozole as Therapy for the Treatment of Recurrent Metastatic Endometrial Cancer and Other Gynecologic Malignancies |
Actual Study Start Date : | March 29, 2023 |
Estimated Primary Completion Date : | January 2026 |
Estimated Study Completion Date : | February 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Escalating daily doses of narazaciclib in combination with letrozole (2.5mg day) Phase 1: Initiating at 160mg per day of narazaciclib, patients will receive escalating doses of narazaciclib (oral tablets/once daily) in combination with 2.5mg of letrozole (oral tablet/once daily). Phase 2: All patients will receive the recommended phase 2 dose (RP2D) of the combination of narazaciclib (oral tablets) and letrozole (oral tablet/QD) |
Drug: Narazaciclib Drug: Letrozole 2.5mg |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85711
Recruiting
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Recruiting
NYU Langone
New York, New York, United States, 10016
Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States, 97401
Recruiting
Greenville Health System, Institute for Oncology Clinical Research
Greenville, South Carolina, United States, 29605
Recruiting
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Recruiting
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States, 76104