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Mitotic Inhibitor
TAK-228 for Solid Tumors
Phase 1
Waitlist Available
Led By Casey Williams, PharmD
Research Sponsored by Avera McKennan Hospital & University Health 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 days 1, 8, 15, 22 of cycle 1 and 2. days 1 and 15 of cycles 3-8. day 1 of each subsequent cycle (each cycle is 28 days). at the study termination visit (within 30 days of last dose of treatment)
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to see if it is safe and effective for treating advanced solid tumors.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 8, 15, 22 of cycle 1 and 2. days 1 and 15 of cycles 3-8. day 1 of each subsequent cycle (each cycle is 28 days). at the study termination visit (within 30 days of last dose of treatment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 15, 22 of cycle 1 and 2. days 1 and 15 of cycles 3-8. day 1 of each subsequent cycle (each cycle is 28 days). at the study termination visit (within 30 days of last dose of treatment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum tolerated dose
Secondary outcome measures
objective response rate
Other outcome measures
Assess whether patients with genomic alterations respond more favorably in the combination when genomic testing via Foundation Medicine tissue assay FoundationOne used
Symptom severity as measured by the Therapy Related Symptoms Checklist (TRSC)
symptom occurrence as measured by the Health-Related Quality of Life Linear Analogue Self-Assessment (HRQOL- LASA)
+2 moreSide effects data
From 2019 Phase 2 trial • 28 Patients • NCT02988986100%
Nausea
4%
hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-228 and Tamoxifen
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment3 Interventions
Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 4mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Group II: Cohort 4Experimental Treatment3 Interventions
Paclitaxel 80mg/m Day 1, Day 8, Day 15 TAK-228 3mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Group III: Cohort 3Experimental Treatment3 Interventions
Paclitaxel 80mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Group IV: Cohort 2Experimental Treatment3 Interventions
Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 200mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Group V: Cohort 1Experimental Treatment3 Interventions
Paclitaxel 60mg/m2 Day 1, Day 8, Day 15 TAK-228 2mg Days 2-4, Days 9-11, Days 16-18, Days 23-25 TAK-117 100mg Days 2-4, Days 9-11, Days 16-18, Days 23-25
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serabelisib
Not yet FDA approved
Paclitaxel
FDA approved
Sapanisertib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Avera McKennan Hospital & University Health CenterLead Sponsor
34 Previous Clinical Trials
29,157 Total Patients Enrolled
Casey Williams, PharmDPrincipal InvestigatorAvera Cancer Institute
2 Previous Clinical Trials
25,016 Total Patients Enrolled
Frequently Asked Questions
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