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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915576
The ClinicalTrials.gov registry entry for NCT01915576 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.