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NCT01915576 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
A Phase 1 study of Neoplasms, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
- 7
- Study locations
NCT01915576: Completed Phase 1 study of Neoplasms, sponsored by Bayer.
NCT01915576 is a Phase 1 study of Neoplasms that has completed, run by Bayer. The registered enrollment target is 79 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915576, a Phase 1 study of Neoplasms, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative bioavailability of liquid service formulation and tablets will be determined. After the MTD is defined breast cancer patients with and without AKT1 mutation will be treated. The study will also assess the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1125976. BAY1125976 will be given daily as single oral application. Treatment will be stopped if the tumor continues to grow, if side effects, which the patient cannot tolerate, occur or if the patient decides to exit treatment.
Conditions Studied
Interventions
- DRUG BAY1125976
Study Locations (7)
California
- - Santa Monica
Massachusetts
- - Boston
Missouri
- - St Louis
Texas
- - Houston
Other
- - Villejuif
Baden-Wurttemberg
- - Heidelberg
Canton of St. Gallen
- - Sankt Gallen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01915576 record still lists
NCT01915576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which BAY1125976 is the first listed.
NCT01915576 lists 7 locations in 7 states (California, Massachusetts, Missouri).
Frequently Asked Questions
What is clinical trial NCT01915576 about?
NCT01915576 is a clinical study titled "Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients". This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1125976. The relative bioavailability of liquid service...
What is the current status of trial NCT01915576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 2013-09. Estimated completion is 2016-12.
What conditions does trial NCT01915576 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT01915576?
The interventions under investigation include: BAY1125976 (DRUG).
Who is sponsoring clinical trial NCT01915576?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01915576 being conducted?
This trial has 7 study locations across California, Massachusetts, Missouri, Texas, Baden-Wurttemberg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01915576's enrollment target sits among peer trials
79 83rd of 158 higher than 75 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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