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NCT01760525 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors
A Phase 1 study of Solid Tumor With p53 Wild Type Status, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 5
- Study locations
NCT01760525: Completed Phase 1 study of Solid Tumor With p53 Wild Type Status, sponsored by Novartis Pharmaceuticals.
NCT01760525 is a Phase 1 study of Solid Tumor With p53 Wild Type Status that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01760525, a Phase 1 study of Solid Tumor With p53 Wild Type Status, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).
Primary Outcome
To characterize the maximum tolerated dose (MTD) and/or identify the recommended dose for expansion(RDE) of CGM097. Dose Limiting Toxicities will be listed and their incidence summarized by primary system organ class, worst grade based on CTCAE version 4.03 and type of Adverse Event
Conditions Studied
Interventions
- DRUG CGM097
Study Locations (5)
Other
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Singapore
- Novartis Investigative Site - Zurich
Massachusetts
- Dana Farber Cancer Institute SC (2) - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-03-20 |
| Est. Completion | 2020-07-24 |
| Phase | Phase 1 |
What the finished NCT01760525 record still lists
NCT01760525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Solid Tumor With p53 Wild Type Status appearing as the primary indexed condition, and to 1 intervention - of which CGM097 is the first listed.
NCT01760525 lists 5 locations in 2 states (Other, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01760525 about?
NCT01760525 is a clinical study titled "A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors". This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will ...
What is the current status of trial NCT01760525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2013-03-20. Estimated completion is 2020-07-24.
What conditions does trial NCT01760525 study?
This clinical trial studies the following conditions: Solid Tumor With p53 Wild Type Status.
What interventions are being tested in trial NCT01760525?
The interventions under investigation include: CGM097 (DRUG).
Who is sponsoring clinical trial NCT01760525?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01760525 being conducted?
This trial has 5 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01760525's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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