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NCT03154294 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors
A Phase 1 study, sponsored by Avera McKennan Hospital & University Health Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03154294: Completed Phase 1 study, sponsored by Avera McKennan Hospital & University Health Center.
NCT03154294 is a Phase 1 study that has completed, run by Avera McKennan Hospital & University Health Center. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03154294, a Phase 1 study, has completed, sponsored by Avera McKennan Hospital & University Health Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is an open-label, cohort study to determine the feasibility and tolerability of the combination of TAK-228 and TAK-117 given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel on days 1, 8, and 15 for one 28-day cycle in patients with advanced solid tumors.
Primary Outcome
DLT is defined as any death not clearly due to underlying disease or extraneous causes; critical liver injury by Hy's Law; grade 3 or higher toxicity (with certain exceptions); inability to administer at least 75% of planned doses of TAK-228 within Cycle 1, due to study drug-related toxicity and any other clinically significant occurrence that the investigator and sponsor agree would place patients at an undue safety risk.
Interventions
- DRUG paclitaxel
- DRUG TAK-228
- DRUG TAK-117
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-07-06 |
| Est. Completion | 2022-11-20 |
| Phase | Phase 1 |
What the finished NCT03154294 record still lists
NCT03154294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which paclitaxel is the first listed.
NCT03154294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03154294 about?
NCT03154294 is a clinical study titled "Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors". This is an open-label, cohort study to determine the feasibility and tolerability of the combination of TAK-228 and TAK-117 given on days 2-4, 9-11, 16-18, and 23-25 with paclitaxel on days 1, 8, and 15 for one 28-day cycle in patients with advanced solid tumors.
What is the current status of trial NCT03154294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-07-06. Estimated completion is 2022-11-20.
What interventions are being tested in trial NCT03154294?
The interventions under investigation include: paclitaxel (DRUG), TAK-228 (DRUG), TAK-117 (DRUG).
Who is sponsoring clinical trial NCT03154294?
This trial is sponsored by Avera McKennan Hospital & University Health Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03154294's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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