Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04520139|
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Cognitive Impairment||Drug: N-Acetyl-Cysteine Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Phase 1 will be a dose-escalating design.
Phase 2 will be a randomized, double-blinded, placebo-controlled study design
|Masking:||Double (Participant, Investigator)|
Phase 1 will be open label.
Phase 2 will be be double-blinded.
|Official Title:||Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||April 2025|
Experimental: Phase 1 Dose Escalation
Patients will receive NAC beginning at Cohort 1. If, at a given dose, none of the 3 patients shows a dose-limiting toxicity during the first cycle of PBT, then the dose is escalated 1 step for subsequent subjects. If, at a given dose, only 1 of 3 shows a dose-limiting toxicity, then up to 3 additional participants will be enrolled at that dose.If, at a given dose, the first 2, or any 2 of 3 subjects show a dose-limiting toxicity, then the dose will be de-escalated 1 step for future participants. At a dose where enrollment is expanded to between 4 and 6, if only 1 of 6 subjects shows a dose-limiting toxicity, then the dose will be escalated 1 step for future participants. However, if 2 or more of 4, 5, or 6participants show a dose-limiting toxicity, then the dose will be reduced one step for future participants. The maximum tolerated dose is defined as the highest dose not requiring deescalation. This is the dose to be used for the NAC arm of Phase II study.
Experimental: Phase 2 Dose Expansion
Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.
- Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy [ Time Frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. ]Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.
- Recommended Phase 2 Dose for NAC administered with PBT [ Time Frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first. ]Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520139
|Contact: Chao Family Comprehensive Cancer Center University of California, Irvinefirstname.lastname@example.org|
|Contact: University of California Irvine Medical|
|Principal Investigator:||Daniela Bota, MD, PhD||Chao Family Comprehensive Cancer Center|