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Fluoropyrimidine

Tesetaxel every 3 weeks for Breast Cancer

Phase 2
Waitlist Available
Led By Andrew D Seidman, MD
Research Sponsored by Genta Incorporated
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 up to 30 days after patients' last dose of study medication
Awards & highlights

Study Summary

This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after patients' last dose of study medication
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after patients' last dose of study medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate
Secondary outcome measures
Adverse events
Clinical benefit rate
Progression-free survival
+1 more

Side effects data

From 2014 Phase 2 trial • 17 Patients • NCT01064713
23%
fatigue
15%
anorexia
15%
vomiting
15%
constipation
15%
muscle weakness
15%
taste alteration
15%
nausea
8%
peripheral neuropathies
8%
stomatitis
8%
chills
8%
headaches
8%
diarrhea
8%
pain
8%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
40 Tesetaxel, Cohort A
50 mg Tesetaxel, Cohort B

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tesetaxel weeklyExperimental Treatment1 Intervention
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 in a 28-day cycle
Group II: Tesetaxel every 3 weeksExperimental Treatment1 Intervention
Tesetaxel 27 mg/m2 orally on Day 1 in a 21-day cycle
Group III: CapecitabineActive Control1 Intervention
Capecitabine 1250 mg/m2 orally twice daily (equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 in a 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tesetaxel
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Genta IncorporatedLead Sponsor
30 Previous Clinical Trials
1,457 Total Patients Enrolled
Andrew D Seidman, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
2012. "Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01609127.
All > Metastatic Breast Cancer
~16 spots leftby Apr 2025
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