Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors
NCT ID: NCT02703571
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
95 participants
INTERVENTIONAL
2016-06-29
2019-09-24
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Advanced or metastatic solid tumors
Patients in the Phase I portion of the study who have advanced or metastatic solid tumors
ribociclib
Combination treatment with LEE and TMT
Trametinib
Combination treatment with LEE and TMT
Interventions
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ribociclib
Combination treatment with LEE and TMT
Trametinib
Combination treatment with LEE and TMT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patient must have specified laboratory values within normal limits or corrected to within normal limits with supplements before the first dose of study medication on Cycle 1 Day 1:
* Standard 12-lead ECG values defined
Exclusion Criteria
• 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
* Active viral hepatitis
* Portal hypertension
* Drug induced liver steatosis
* Prior systemic anti-cancer treatment within 28 days prior to Cycle 1 Day 1
* Prior therapy with anthracyclines at cumulative doses of 450 mg/ m2 or more for doxorubicin or 900 mg/m2 or more for epirubicin.
* Patient is currently receiving warfarin or other coumadin derived anti-coagulant
* Patient has a history of deep venin thrombosis or pulmonary embolism within 6 months of screening.
* Patient has a concurrent malignancy or malignancy within 3 years prior to Cycle 1 Day 1, with the exception of adequately treated basal or squamous cell carcinoma or curatively resected cervical cancer.
* Patients with central nervous system (CNS) involvement
* Patient has impairment of GI function or GI disease that may significantly alter the absorption of the study drugs
* History of interstitial lung disease or pneumonitis.
* Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
* Patient is currently receiving any strong inducers or inhibitors of CYP3A4/5 and/or Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5 and cannot be discontinued 7 days prior to Cycle 1 Day 1:
* Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.
* History of retinal vein occlusion (RVO)
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Barcelona, Catalonia, Spain
Countries
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Related Links
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Results for CTMT212X2106 from the Novartis Clinical Trials Website
Other Identifiers
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2015-005019-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTMT212X2106
Identifier Type: -
Identifier Source: org_study_id