A Phase I Dose Escalation Study of CGM097 in Adult Patients With Selected Advanced Solid Tumors (CCGM097X2101)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor With p53 Wild Status |
Drug: CGM097 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors |
- Incidence of Dose Limiting Toxicities [ Time Frame: From day 1 to day 28 of treatment ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 92 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CGM097 - Dose escalation |
Drug: CGM097
Patients treated with CGM097
|
| Experimental: CGM097 - Dose Expansion at MTD or RP2D |
Drug: CGM097
Patients treated with CGM097
|
Detailed Description:
This is a multi-center, open-label, dose finding, phase I study of single agent CGM097, administered in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. Patients' tumors must be characterized by p53wt status.
The study consists of a dose escalation part, where cohorts of three to six newly enrolled patients will receive escalating doses of CGM097, and a dose expansion part, in which patients are given CGM097 the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Novartis and the site investigators will jointly decide on each dose escalation step based on the recommendation from an adaptive Bayesian logistic regression model (BLRM). If safety data should indicate a lower increment than suggested by the BLRM, the next dose level (DL) will be adjusted accordingly.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has advanced solid malignancy that has progressed despite standard therapy, or for which no effective standard therapy exists
- Tumor of the patient is p53wt
- Evaluable disease as determined by RECIST 1.1
- WHO performance status 0-2
Exclusion criteria:
- Prior treatment with CGM097 or other p53/HDM2-interaction inhibitor
- Patient with symptomatic or growing CNS metastatic lesions
- Concurrent other malignancy
- Clinically significant cardiac disease as defined in the protocol
- Diagnosis of acute or chronic pancreatitis
- Concomitant therapy that precludes enrollment, as defined in the protocol
- Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation
- Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
| United States, Massachusetts | |
| Dana Farber Cancer Institute SC (2) | Not yet recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Julie Field 617-632-6708 julie_field@dfci.harvard.edu | |
| Principal Investigator: George D. Demetri | |
| France | |
| Novartis Investigative Site | Recruiting |
| Lyon Cedex, France, 69373 | |
| Germany | |
| Novartis Investigative Site | Recruiting |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | Not yet recruiting |
| Köln, Germany, 50924 | |
| Singapore | |
| Novartis Investigative Site | Recruiting |
| Singapore, Singapore, 169610 | |
| Switzerland | |
| Novartis Investigative Site | Recruiting |
| Zürich, Switzerland, 8091 | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01760525 History of Changes |
| Other Study ID Numbers: | CCGM097X2101, 2012-000940-87 |
| Study First Received: | January 2, 2013 |
| Last Updated: | June 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
p53, solid tumor |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on June 13, 2013