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Mitotic Inhibitor
Treatment (mivavotinib and paclitaxel) for Ovarian Cancer
Phase 1
Waitlist Available
Led By Siqing Fu
Research Sponsored by M.D. Anderson Cancer Center
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 4 years
Awards & highlights
Study Summary
This study is evaluating whether a combination of two drugs may be more effective than either drug alone in treating patients with advanced solid tumors.
Eligible Conditions
- Ovarian Cancer
- Cancer
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To define the maximum tolerated doses (MTD) of TAK-659 and paclitaxel
Secondary outcome measures
Categorization of response based on Response Evaluation Criteria in Solid Tumors 1.1
Dose-limiting toxicity
Minimum detectable effect size
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (mivavotinib and paclitaxel)Experimental Treatment3 Interventions
Patients receive mivavotinib PO QD and paclitaxel IV over approximately 1 hour on days 1, 8, and 15. 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
Mivavotinib
2019
Completed Phase 1
~60
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,802 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,294 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,745 Patients Enrolled for Ovarian Cancer
Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
490 Total Patients Enrolled
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