MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01352273 |
Recruitment Status :
Completed
First Posted : May 11, 2011
Last Update Posted : September 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Drug: MEK162 + RAF265 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib Open-label Dose Escalation Study of MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: MEK162 + RAF265 |
Drug: MEK162 + RAF265 |
- Incidence of Dose Limiting Toxicities [ Time Frame: during the first 28 days of treatment with RAF265 and MEK162 ]
- Number of participants with adverse events and serious adverse events [ Time Frame: 18 months ]
- assess preliminary anti-tumor activity of the combination [ Time Frame: every 8 weeks of treatment ]CT scan will be performed
- Tumor skin and blood samples will be collected before and during treatment with RAF265 and MEK162 to assess the combination's effects on the RAF/MEK/MAPK pathway with the clinical outcomes [ Time Frame: 18 months ]
- Time versus plasma concentration profiles of RAF265 and MEK162 [ Time Frame: 10 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists.
- The patients' tumors must contain documented activating somatic BRAFV600E* , NRAS or KRAS mutations (except for pancreatic cancer)
- All patients enrolled MUST provide fresh or archival tumor samples at baseline to enable central confirmation of BRAF or KRAS/NRAS mutations
- Measurable, or non-measurable but evaluable disease as determined by RECIST
- Adequate bone marrow function
- Adequate hepatic and renal function
- Adequate cardiovascular function
- Negative serum β HCG test (female patients of childbearing potential only) within 72 hrs prior to first dose
Exclusion Criteria:
- Patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
- Current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for CSR/RVO (e.g., optic disc cupping, visual field defects, IOP > 21 mm Hg)
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Impaired cardio-/vascular function or clinically significant cardiovascular diseases, including any of the following:
- History/evidence of acute coronary syndromes (including MI, unstable angina, CABG, coronary angioplasty, or stenting) ≤ 6 months prior to starting study drugs
- Thromboembolic event (DVT, CVA, PE) ≤ 6 months prior to starting study
- Symptomatic CHF, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality
- Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg (average of 3 consecutive readings)
- History of melena, hematemesis or hemoptysis within the last 3 months
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
Other protocol-defined inclusion/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352273
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute Moffitt 4 | |
Tampa, Florida, United States, 33612 | |
United States, Oregon | |
Oregon Health & Science University OHSU 3 | |
Portland, Oregon, United States, 97239 | |
United States, Utah | |
University of Utah / Huntsman Cancer Institute Huntman 2 | |
Salt Lake City, Utah, United States, 84103 | |
Canada, Alberta | |
Pfizer Investigative Site | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Quebec | |
Pfizer Investigative Site | |
Montreal, Quebec, Canada, H3T 1E3 | |
Norway | |
Pfizer Investigative Site | |
Oslo, Norway, NO-0379 | |
Spain | |
Pfizer Investigative Site | |
Madrid, Spain, 28050 | |
Switzerland | |
Pfizer Investigative Site | |
Zürich, Switzerland, 8091 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Array Biopharma, now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT01352273 |
Other Study ID Numbers: |
CMEK162X2102 2010-023812-14 ( EudraCT Number ) |
First Posted: | May 11, 2011 Key Record Dates |
Last Update Posted: | September 30, 2020 |
Last Verified: | September 2020 |
advanced Solid tumors harboring RAS harboring BRAFV600E |
Neoplasms |