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Trametinib

Protein Kinase Inhibitors

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Patients in the Phase I portion of the study who have advanced or metastatic solid tumors

ribociclib

Novartis Pharmaceuticals

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.

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.

single group for phase 1b parallel group for phase 2

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

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Phase Ib part:

The primary variable is the incidence of DLTs during the first 21 days of therapy. Estimation of the MTD of the combination treatment will be based upon the estimation of the probability of DLT during the first 21 days of therapy for patients in the DDS.

Phase II part:

The primary variable used to evaluate the efficacy of the ribociclib and trametinib combination is the ORR, defined as the proportion of patients with a best overall confirmed CR or PR, as assessed per RECIST 1.1 by investigator assessment.

Phase II part:

Among patients with a confirmed response (PR or CR) per RECIST 1.1, DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression or death due to any cause. The distribution function of DOR will be estimated using the Kaplan-Meier method. The median DOR along with 95% CI will be presented by treatment arm.

Phase II part:

Time to overall response of CR or PR (TTR) is defined as the time from start of study drug to first documented response (CR or PR, which must be confirmed subsequently) for patients with a confirmed CR or PR. TTR will be summarized by treatment arm, using descriptive statistics.

Phase II part:

Disease control rate (DCR) is defined as the proportion of patients with best overall response of CR, PR, or SD per RECIST 1.1. DCR will be estimated and the binomial exact 95% CI will be provided by arm.

Phase Ib part:

Progression disease rate defined as the proportion of patients with a progression disease as assessed per RECIST 1.1 by investigator assessment.

Phase Ib and phase II parts:

Progression-free survival (PFS) is defined as the time from the date of the first dose of study drug to the date of first documented disease progression per RECIST 1.1 or death due to any cause.

Phase Ib and phase II parts:

Overall survival (OS) is defined as the time from the date of first dose of study drug to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors	NCT02703571	Solid Tumors fo... Pancreatic Canc... Colorectal Canc...	ribociclib Trametinib	18 Years -	Novartis
Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors	NCT02703571	Solid Tumors fo... Pancreatic Canc... Colorectal Canc...	ribociclib Trametinib	18 Years -	Novartis

Spots Global Cancer Trial Database for solid tumors for phase ib