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



Status:Recruiting
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/9/2018
Start Date:June 29, 2016
End Date:March 16, 2021
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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

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.


Inclusion Criteria (All):

- 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

- 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:

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

- 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)

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
7
sites
333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Patricia M. LoRusso
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Boston, Massachusetts 02115
Principal Investigator: Geoffrey Shapiro
Phone: 617-632-5638
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Marwan G. Fakih
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck
Phone: 479-587-1700
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Houston, Texas 77030
Principal Investigator: Filip Janku
Phone: 713-792-3238
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Houston, TX
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Melbourne, Victoria
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1475 Northwest 12th Avenue
Miami, Florida 33136
Principal Investigator: Jaime Merchan
Phone: 305-243-0865
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Miami, FL
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