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Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A Phase I/II Study of Safety and Efficacy of Ribociclib (LEE011) in Combination With Trametinib (TMT212) in Patients With Metastatic or Advanced Solid Tumors

NCT02703571•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed Description

Upon careful review of all available efficacy and safety data from the study phase Ib part, Novartis decided to not start the study phase II part. This decision was in no means triggered by an unfavorable safety profile of the combination. The observed safety profile of the combination represents contributions of the individual safety profile of trametinib and ribociclib. No new safety signals were observed. The study was closed early in line with protocol Section 4.4.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent must
•Patient has histologically and/or cytologically confirmed malignancies:
•Phase I:
•Patients with advanced or metastatic solid tumors who have failed at least one prior line of systemic antineoplastic therapy in the advanced setting without a standard of care treatment option available;
•Phase II:
•Advanced or metastatic pancreatic adenocarcinoma who have failed at least one prior systemic antineoplastic therapies in the advanced setting
•Advanced or metastatic KRAS-mutant CRC who have failed at least two prior systemic antineoplastic therapies in the advanced setting without a standard of care treatment option available. Testing for KRAS mutation in patients with CRC using locally approved diagnostic kit will be used for eligibility.
•Phase II only: patient must have measurable disease
•Patient has an ECOG performance status 0 or 1.
•Patient has adequate bone marrow and organ function
+2 more criteria

Exclusion Criteria

•Phase II only:
•Patient has received prior treatment with a MEK inhibitor or a CDK4/6 inhibitor.
•Phase I and Phase II:
•Patient with a known hypersensitivity to the study drugs or any of the excipients of ribociclib or trametinib.
•Patient is concurrently using other anti-cancer therapy.
•Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to Cycle 1 Day 1
•Patient has received local therapy to liver ≤ 3 months of C1D1
•History of liver disease as follow:
•Cirrhosis
•Autoimmune hepatitis
+15 more criteria

Locations (15)

Highlands Oncology Group

Fayetteville, Arkansas, United States

City of Hope National Medical Center

Duarte, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

University of Miami Sylvester Comp Cancer Ctr

Miami, Florida, United States

Dana Farber Cancer Center

Boston, Massachusetts, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Key Dates

Start Date

June 29, 2016

Primary Completion Date

September 24, 2019

Completion Date

September 24, 2019

Last Updated

December 21, 2020

Enrollment

ACTUAL participants

Conditions

Solid Tumors for Phase IbPancreatic Cancer for Phase IIColorectal Cancer for Phase II

Interventions

ribociclib

DRUG

Trametinib

DRUG