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Epigenetic Modulator

SNDX-5613 for Colorectal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Syndax Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have experienced documented unequivocal progressive disease by either RECIST v1.1 or clinical assessment, or experienced unacceptable toxicity with their prior therapy
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights

Study Summary

This trial will test a new drug for people with colorectal cancer or solid tumors who have already tried other treatments.

Who is the study for?
Adults over 18 with colorectal or other solid tumors that have worsened after treatment, or who couldn't tolerate standard therapies including oxaliplatin, irinotecan, and bevacizumab. They must not have active infections like hepatitis B/C or HIV, serious heart conditions in the past 6 months, certain GI issues affecting drug absorption, brain metastasis requiring steroids, or any condition that might interfere with study participation.Check my eligibility
What is being tested?
The trial is testing SNDX-5613 combined with chemotherapy to see how safe it is and how well it works against colorectal cancer and other solid tumors in patients who've already tried at least one line of therapy without success.See study design
What are the potential side effects?
Possible side effects include typical reactions to chemotherapy such as nausea, fatigue, hair loss; specific side effects related to SNDX-5613 are being studied but may involve changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened or I had severe side effects from previous treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have colorectal cancer and treatments like oxaliplatin, irinotecan, and bevacizumab didn't work for me.
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I finished radiation therapy 2 weeks ago and still have at least one tumor that can be measured.
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I have metastatic colorectal cancer or another type of advanced solid tumor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities
Phase 1b: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles)
+2 more
Secondary outcome measures
Phase 1: Area Under the Plasma Concentration Versus Time Curve (AUC) of SNDX-5613
Phase 1: Maximum Plasma Concentration (Cmax) of SNDX-5613
Phase 1: Time to Maximum Plasma Concentration (Tmax) of SNDX-5613
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: SNDX-5613Experimental Treatment1 Intervention
Participants will receive SNDX-5613 tablets TID or BID from Day 1 of each 28-day cycle.
Group II: Phase 1b: Signal-SeekingExperimental Treatment1 Intervention
Participants will receive SNDX-5613 tablets TID or BID from Day 1 of each 28-day cycle.
Group III: Phase 1a: Dose EscalationExperimental Treatment1 Intervention
Participants will receive SNDX-5613 tablets or capsules three times a day (TID) or two times a day (BID) from Day 1 of each 28-day cycle.
Group IV: Phase 2: ChemotherapyActive Control1 Intervention
Participants will receive chemotherapy from Day 1 of each 28-day cycle.

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,616 Total Patients Enrolled

Media Library

SNDX-5613 (Epigenetic Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05731947 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings available for enrolment in this medical trial?

"Affirmative. Findings hosted on clinicaltrials.gov demonstrate that this medical investigation, which was originally posted on March 1st 2023, is actively enrolling participants. 158 people must be recruited from 2 distinct research centres."

Answered by AI

How many people have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov's information shows that this clinical study, which was first made available on March 1st 2023, is still recruiting participants. 158 patients need to be accepted from two medical sites."

Answered by AI
~58 spots leftby Dec 2024