Overview

This trial is active, not recruiting.

Condition solid tumor with p53 wild type status
Treatment cgm097
Phase phase 1
Sponsor Novartis Pharmaceuticals
Start date March 2013
End date June 2017
Trial size 51 participants
Trial identifier NCT01760525, 2012-000940-87, CCGM097X2101

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cgm097
Patients treated with CGM097
(Experimental)
cgm097
Patients treated with CGM097

Primary Outcomes

Measure
Incidence of Dose Limiting Toxicities
time frame: From day 1 to day 28 of treatment

Secondary Outcomes

Measure
Pharmacokinetic profile of CGM097
time frame: At Cycle 1 Day 1, 2, 5, 8, 15 and 22, then each first day of the Cycle (28 days per Cycle) until discontinuation.
Tumor response per RECIST
time frame: Baseline, then every third cycle (approximately every 12 weeks), until disease progression or discontinuation.
Pharmacodynamic effect of CGM097
time frame: At baseline, Cycle 2 Day 8 and at disease progression.
Changes in laboratory values, vital signs or cardiac functionality, dose reduction, dose interruption and dose intensity, incidence and severity of adverse events.
time frame: At Cycle 1 Day 1, 2, 5, 8, 15, 22 and 28, Cycle 2 Day 1, 8,15 and 22, then each Day 1 and 15 of the Cycle until discontinuation. For dose interruption, dose intensity and adverse events: each day of the Cycle until discontinuation (28 days per Cycle).

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in July 2016.