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Navtemadlin for Endometrial Cancer
Phase 2 & 3
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 months
Awards & highlights
Study Summary
This trial will assess the safety and effectiveness of a drug, navtemadlin, to treat advanced or recurrent endometrial cancer. It will compare two doses of the drug to a placebo to determine the best dose.
Who is the study for?
This trial is for patients with advanced or recurrent endometrial cancer who responded well to a specific chemo. They must have normal TP53 genes, good performance status (ECOG 0-1), and proper blood, liver, and kidney function. It's not for those with recent major bleeding, organ transplants, certain other cancers, recent experimental therapies or immune/cytokine therapy.Check my eligibility
What is being tested?
The study tests navtemadlin as a maintenance treatment after chemotherapy success in two parts: first to find the best dose comparing two levels of navtemadlin against observation; second to compare that dose's effectiveness and safety against a placebo.See study design
What are the potential side effects?
While specific side effects of navtemadlin are not listed here, common ones may include fatigue, nausea, risk of infection due to low blood counts from bone marrow suppression; liver or kidney issues could also be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: To determine the navtemadlin Phase 3 dose
Part 2: To compare progression-free (PFS) survival by independent review committee (IRC) between navtemadlin and placebo
Secondary outcome measures
Part 1: To evaluate the treatment effect of navtemadlin on PFS by IRC and investigator assessment
Part 2: To evaluate the treatment effect of navtemadlin on the time to first subsequent treatment (TFST)
Parts 1 and 2: To determine the pharmacokinetic (PK) profile of navtemadlin
+1 moreTrial Design
7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part 2 Arm BExperimental Treatment1 Intervention
Navtemadlin administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Group II: Part 2 Arm AExperimental Treatment1 Intervention
Navtemadlin administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Group III: Part 1 Arm 2Experimental Treatment1 Intervention
Navtemadlin administered orally at 240 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Group IV: Part 1 Arm 1Experimental Treatment1 Intervention
Navtemadlin administered orally at 180 mg, once daily (QD) on Days 1-7 in a 28-day treatment cycles.
Group V: Part 1 Arm 3Active Control1 Intervention
Observational control ("watch and wait") on a 28-day cycle.
Group VI: Part 2 Arm DPlacebo Group1 Intervention
Placebo administered orally at 240 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Group VII: Part 2 Arm CPlacebo Group1 Intervention
Placebo administered orally at 180 mg once daily (QD) on Days 1-7 in a 28-day administration cycle.
Find a Location
Who is running the clinical trial?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,182 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
16,971 Total Patients Enrolled
3 Trials studying Endometrial Cancer
598 Patients Enrolled for Endometrial Cancer
GOG FoundationNETWORK
42 Previous Clinical Trials
16,473 Total Patients Enrolled
3 Trials studying Endometrial Cancer
1,230 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major bleeding or brain bleeding in the last 6 months.I currently have surgical drains in place.My cancer is a type of sarcoma or has small-cell features with neuroendocrine traits.I haven't had immune, cytokine, or experimental treatments in the last 28 days.I have had a major organ transplant.I am fully active or can carry out light work.My endometrial cancer is confirmed and does not have TP53 mutations.I completed a specific chemotherapy and my cancer responded well.My blood, liver, and kidney functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Arm 2
- Group 2: Part 2 Arm D
- Group 3: Part 1 Arm 1
- Group 4: Part 1 Arm 3
- Group 5: Part 2 Arm A
- Group 6: Part 2 Arm B
- Group 7: Part 2 Arm C
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to partake in this experiment?
"Affirmative. Clinicaltrials.gov demonstrates that this clinical trial, which was initially posted on July 17th 2023 is still actively recruiting participants. A total of 268 subjects must be enrolled from 4 separate medical centres in order for the trial to continue its research."
Answered by AI
What key goals are being sought through this research effort?
"Across this 12 month study, the primary objective is to compare progression-free (PFS) survival between navtemadlin and placebo as determined by independent review committee (IRC). The secondary goals are to assess the pharmacokinetic profile of navtemadlin; determine time of maximum plasma concentration (Tmax); and evaluate treatment effect on disease control rate (DCR), with best response from prior chemotherapy being partial response."
Answered by AI
What is the aggregate number of participants enrolled in this medical experiment?
"Affirmative. Clinicaltrials.gov states that this research project is presently in the process of recruiting participants, commencing on July 17th 2023 and most recently updated on August 3rd 2023. In total, 268 patients must be sourced from 4 distinct medical facilities."
Answered by AI
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