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Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

NCT02703571 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-12-21

No results posted yet for this study

Summary

Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.

Conditions

  • Solid Tumors for Phase Ib
  • Pancreatic Cancer for Phase II
  • Colorectal Cancer for Phase II

Interventions

DRUG

ribociclib

Combination treatment with LEE and TMT

DRUG

Trametinib

Combination treatment with LEE and TMT

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-29
Primary Completion
2019-09-24
Completion
2019-09-24
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02703571 on ClinicalTrials.gov