A Phase 1 interventional study of ribociclib and Trametinib in Solid Tumors for Phase Ib, Pancreatic Cancer for Phase II and Colorectal Cancer for Phase II, sponsored by Novartis Pharmaceuticals. Terminated at 15 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-21.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 95 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Phase I:
Phase II:
Exclusion Criteria:
Phase II only:
Phase I and Phase II:
Other protocol-defined inclusion/exclusion criteria may apply.
Patients in the Phase I portion of the study who have advanced or metastatic solid tumors
Drug: ribociclib · Drug: Trametinib
Combination treatment with LEE and TMT
Also known as: LEE011
Combination treatment with LEE and TMT
Also known as: TMT212
Incidence of dose limiting toxicities (DLTs)
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.
Time frame: 21-day cycle one of treatment
Objective Response Rate (ORR)
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.
Time frame: Until progression of disease up to 1 year
Duration of response (DOR)
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.
Time frame: Until progression of disease up to 1 year
Time to response
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.
Time frame: Until progression of disease up to 1 year
Disease control rate
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.
Time frame: Until progression of disease up to 1 year
Progression disease rate
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.
Time frame: Until progression of disease up to 1 year
Progression free survival
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.
Time frame: Until progression of disease up to 1 year
overall survival
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.
Time frame: Until death up to 1 year
Plan to share: Undecided — 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
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals