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Microtubule Stabilizer
Group 1 - Dose Finding for Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by Translational Research in Oncology
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 all patients from group 1 and 5-8 patients from group 2 will be considered as the pk subset. plasma samples will be obtained at the pre-determined time points during cycle 2 - days 1 and 2. following cycle 1, treatment cycles are 28 days.
Awards & highlights
Study Summary
This trial will enroll up to 45 patients with advanced breast cancer who have failed standard treatments. They will receive tomivosertib for 14 days, followed by weekly paclitaxel. Tumor assessments will be done throughout the trial.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all patients from group 1 and 5-8 patients from group 2 will be considered as the pk subset. plasma samples will be obtained at the pre-determined time points during cycle 2 - days 1 and 2. following cycle 1, treatment cycles are 28 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all patients from group 1 and 5-8 patients from group 2 will be considered as the pk subset. plasma samples will be obtained at the pre-determined time points during cycle 2 - days 1 and 2. following cycle 1, treatment cycles are 28 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Pharmacodynamic Effects (PD) Following 14 Days of Tomivosertib Monotherapy
Number of Patients with Adverse Events (AEs)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Overall Response Rate (ORR)
Pharmacokinetic Effects (PK)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2 - Dose ExpansionExperimental Treatment2 Interventions
It is anticipated that Group 2 patients will receive tomivosertib at a dose of 100 mg orally twice daily (BID) during the 'run-in' period, which is taken in combination with weekly paclitaxel (according to market label) during the 'post run-in' period.
Group II: Group 1 - Dose FindingExperimental Treatment2 Interventions
The first 3 patients enrolled in Group 1 will receive tomivosertib at a dose of 100 mg orally twice daily (BID), under fasting conditions, and will be assessed for dose limiting toxicities (DLTs) during this 'run-in' period. They will also receive the first cycle of tomivosertib IN COMBINATION with weekly paclitaxel in the 'post run-in' period. Depending on the occurrence/absence of DLTs, this first group of 3 patients may need to be expanded (up to 9 patients) or the trial may proceed to start enrollment in Group 2 (detailed in the arm below).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tomivosertib
2020
Completed Phase 1
~20
paclitaxel
1996
Completed Phase 3
~4310
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Who is running the clinical trial?
Translational Research in OncologyLead Sponsor
21 Previous Clinical Trials
6,658 Total Patients Enrolled
2 Trials studying Breast Cancer
58 Patients Enrolled for Breast Cancer
Effector TherapeuticsIndustry Sponsor
9 Previous Clinical Trials
454 Total Patients Enrolled
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,275 Total Patients Enrolled
3 Trials studying Breast Cancer
127 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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