Status:
TERMINATED
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities ...
Detailed Description
Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination. Remaining patients on treatme...
Eligibility Criteria
Inclusion
- Written informed consent
- Male and female patients aged 18 years or older
- A history of uveal (ocular) melanoma with biopsy-confirmed metastatic disease
- Consent to providing 3 tumor biopsy samples throughout the course of the study
- Presence of measurable disease
- A WHO performance status of less than or equal to 1
Exclusion
- Presence of CNS lesions (stable lesions may be acceptable)
- Previous or concurrent malignancy, other than basal cell or squamous cell carcinoma of the skin: in situ carcinoma of the cervix, without evidence of recurrence for at least 3 years; a primary malignancy completely resected and no evidence of recurrence for at least 3 years
- Adverse event from prior chemotherapy, radiotherapy or surgery that has not recovered to CTCAE v4.03 Grade 1 or less, except for alopecia/sensory peripheral neuropathy, which must be less than Grade 2
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- Impaired cardiac function or clinically significant cardiac disease
- Impaired GI function or disease that could interfere with the absorption of AEB071 and/or MEK162
- Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment
- Females of child-bearing potential who are unwilling or unable to use highly effective means of contraception
- Males who are unwilling or unable to use a condom during sexual intercourse
- Prior exposure to a MEK or PKC inhibitor Other inclusion/exclusion criteria apply
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01801358
Start Date
August 1 2013
End Date
May 1 2015
Last Update
September 16 2020
Active Locations (7)
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1
Dana Farber Cancer Institute Dept. Onc
Boston, Massachusetts, United States, 02215
2
Memorial Sloan Kettering Cancer Center Dept of Onc..
New York, New York, United States, 90033
3
Pfizer Investigative Site
Paris, France, 75231
4
Pfizer Investigative Site
Essen, Germany, 45147