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Heat Shock Protein 90 (HSP90) Inhibitor
Pharmacological Study for Breast Cancer
Phase 1
Waitlist Available
Led By Robert Wesolowski
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Leukocytes >= 2,000/uL
Patients must have histologically confirmed measurable or unmeasurable advanced or metastatic breast cancer for which standard curative measures do not exist or are no longer effective
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment to first documented disease progression according to response evaluation criteria in solid tumors (recist) 1.1 or death from any cause (whichever occurs first), assessed up to 2 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of onalespib when given with paclitaxel to treat patients with advanced triple negative breast cancer.
Eligible Conditions
- Breast Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment to first documented disease progression according to response evaluation criteria in solid tumors (recist) 1.1 or death from any cause (whichever occurs first), assessed up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment to first documented disease progression according to response evaluation criteria in solid tumors (recist) 1.1 or death from any cause (whichever occurs first), assessed up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose (R2PD)
Toxicity profile of onalespib in combination with paclitaxel
Secondary outcome measures
Overall response rate (partial response [PR]+ complete response [CR])
Pharmacokinetic (PK) parameters of onalespib
Pharmacokinetic (PK) parameters of paclitaxel
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (onalespib, paclitaxel)Experimental Treatment4 Interventions
SAFETY RUN-IN: Patients receive onalespib IV over approximately 1 hour on day -7.
TREATMENT: Patients receive paclitaxel IV over 60 minutes on day 1, 8, and 15. Patients also receive onalespib IV over 1 hour beginning on days 8 and 15 of cycle 1 and on days 1, 8, and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Onalespib
2017
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,636 Previous Clinical Trials
40,929,518 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Robert WesolowskiPrincipal InvestigatorOhio State University Comprehensive Cancer Center LAO
Frequently Asked Questions
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