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Aromatase Inhibitor
Narazaciclib + Letrozole for Endometrial Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Onconova 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 from time of first dose until 2 years after end of treatment (up to approximately 3 years).
Awards & highlights
Study Summary
This trial will test if a combination of drugs can safely & effectively treat advanced endometrial cancer.
Who is the study for?
This trial is for adults with recurrent metastatic low-grade endometrioid endometrial cancer who can swallow pills, have had up to two prior systemic treatments (excluding certain therapies), and whose major organs function well. They must not be pregnant, agree to use contraception if applicable, and have a life expectancy of at least 12 weeks.Check my eligibility
What is being tested?
The study tests increasing doses of narazaciclib combined with a standard dose of letrozole in patients with specific gynecologic cancers. It aims to determine the safety and effectiveness of this combination treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions from oral cancer medications such as nausea, fatigue, blood count changes, liver enzyme alterations, or hormonal imbalances. Specific side effects for narazaciclib are not listed but would be monitored closely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of first dose until 2 years after end of treatment (up to approximately 3 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first dose until 2 years after end of treatment (up to approximately 3 years).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicities (DLTs) will be tabulated and summarized by cohort
Phase 2 - Progression-free survival (PFS) at 24 weeks by Investigator assessment
Treatment-emergent adverse events (TEAEs), including DLTs will be graded by CTCAE v5.0
Secondary outcome measures
Complete response (CR) rate
Disease control rate (DCR equals CR+PR+SD)
Duration of response (DoR)
+7 moreOther outcome measures
Measurement of tyrosine kinase activity (TKa) levels in serum
PK: Area under the concentration-time curve (AUC) from time 0 to time of last quantifiable sample (AUC0-t)
PK: Time to reach Cmax (Tmax)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Escalating daily doses of narazaciclib in combination with letrozole (2.5mg day)Experimental Treatment2 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole 2.5mg
2019
Completed Phase 4
~840
Find a Location
Who is running the clinical trial?
Onconova Therapeutics, Inc.Lead Sponsor
31 Previous Clinical Trials
1,601 Total Patients Enrolled
Michael E Saunders, MDStudy ChairOnconova Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled
Mark S Gelder, MDStudy ChairOnconova Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is not related to the uterus or other female reproductive organs.My cancer is not a low-grade or early-stage type.I do not have any serious heart conditions that are not under control.I am fully active or restricted in physically strenuous activity but can do light work.I have severe lung problems or interstitial pneumonia.I have had or currently have uveitis.I have not had major surgery in the last 14 days.I am at risk for a specific type of abnormal heart rhythm.I have recently received a live vaccine.My endometrial cancer is low-grade and mostly endometrioid.I have previously received immunotherapy for my cancer, if it was available and not advised against for me.I have cancer that can be measured and is not in the area that was radiated.I can take pills by mouth.I have been treated with a CDK 4/6 inhibitor before.My cancer's mismatch repair status is known.I may or may not have had treatments for my recurrent/metastatic disease, based on my doctor's advice.My cancer has spread to my brain or the lining around my brain and spinal cord.I cannot be treated with letrozole.I haven't had or been treated for any cancer except certain types in the last 2 years.I do not have any active infections, including bacterial, fungal, or viral.My cancer's hormone receptor status has been tested.My cancer has returned or is in stage IV.I am at least 18 years old or the legal age of consent where the study is conducted.I have severe high calcium levels in my blood.My gynecologic cancer can be treated with hormones and I have no other standard treatment options.My organs are functioning well.I am following the study's rules on sex and contraception.I have had blood clots in my veins recently.I currently have moderate to severe diarrhea.I may have had prior checkpoint inhibitor therapy.My cancer can be measured by tests or seen on scans.I am not currently on, nor have I recently taken, strong drugs that affect liver enzymes CYP2C8 and CYP3A4.I can sign and follow the study's consent form and rules.
Research Study Groups:
This trial has the following groups:- Group 1: Escalating daily doses of narazaciclib in combination with letrozole (2.5mg day)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many participants are currently engaged in this clinical exploration?
"Affirmative. The records posted on clinicaltrials.gov state that this medical research is actively recruiting eligible participants, having been originally published on March 29th 2023 and most recently updated on the 31st of the same month. 60 patients need to be sourced from one trial site."
Answered by AI
Is there an open call for enrolment in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical experiment is still recruiting patients and was first published on March 29th 2023 with later revisions made on the 31st of that month. Currently, 60 participants need to be found from one location."
Answered by AI
What are the anticipated results of this clinical investigation?
"This clinical trial's primary outcome, monitored over a four-week interval from the commencement of treatment, will be to gauge Treatment-emergent Adverse Events (TEAEs) using CTCAE v5.0 criteria. Secondary goals comprise assessing Median Progression Free Survival by Investigator evaluation, plotting Kaplan-Meier curves for Complete Response and Partial Response rates according to RECIST metrics."
Answered by AI
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