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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 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. The trial reports 5 study locations across 2 states.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01760525
The ClinicalTrials.gov registry entry for NCT01760525 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 2 distinct geographic areas - top geographies include 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.
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