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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor With p53 Wild Status

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities

Outcome Description:

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

Outcome Time Frame:

From day 1 to day 28 of treatment

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CCGM097X2101

NCT ID:

NCT01760525

Start Date:

March 2013

Completion Date:

June 2016

Related Keywords:

  • Solid Tumor With p53 Wild Status
  • p53, solid tumor
  • Neoplasms

Name

Location

Dana Farber Cancer Institute SC (2)Boston, Massachusetts  02115