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NCT02197572 · ClinicalTrials.gov registry record · Phase 1
Effect of Sapanisertib (MLN0128) on the QTc Interval in Participants With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 5
- Study locations
NCT02197572: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Calithera Biosciences.
NCT02197572 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Calithera Biosciences. The registered enrollment target is 44 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (78% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197572, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to characterize the effect of a single dose of 40 mg sapanisertib (MLN0128) on the electrocardiographic QT/QTc interval in participants with advanced solid tumors.
Primary Outcome
The mean changes of QTcI from time-matched baseline was measured by electrocardiogram (ECG) to evaluate the potential effect of drug on QTc interval duration. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of QTcI interval.
Conditions Studied
Interventions
- DRUG Sapanisertib
Study Locations (5)
Florida
- - Sarasota
Missouri
- - St Louis
New York
- - The Bronx
Oklahoma
- - Oklahoma City
Texas
- - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 1 |
What the finished NCT02197572 record still lists
NCT02197572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which Sapanisertib is the first listed.
NCT02197572 lists 5 locations in 5 states (Florida, Missouri, New York).
Frequently Asked Questions
What is clinical trial NCT02197572 about?
NCT02197572 is a clinical study titled "Effect of Sapanisertib (MLN0128) on the QTc Interval in Participants With Advanced Solid Tumors". The purpose of this study is to characterize the effect of a single dose of 40 mg sapanisertib (MLN0128) on the electrocardiographic QT/QTc interval in participants with advanced solid tumors.
What is the current status of trial NCT02197572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2014-09-15. Estimated completion is 2019-02-28.
What conditions does trial NCT02197572 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT02197572?
The interventions under investigation include: Sapanisertib (DRUG).
Who is sponsoring clinical trial NCT02197572?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02197572 being conducted?
This trial has 5 study locations across Florida, Missouri, New York, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02197572's enrollment target sits among peer trials
44 106th of 144 higher than 38 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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