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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
Approved for 5 Other Conditions
No Placebo-Only Group

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response rate
Secondary study objectives
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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~16 spots leftby Nov 2025
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