Back to resultsA Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Primary Purpose
Uveal Melanoma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AEB071
MEK162
Sponsored by
About this trial
This is an interventional treatment trial for Uveal Melanoma focused on measuring Melanoma,, melanoma of the eye,, uveal,, MEK162,, AEB071
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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- Treatment with medicines or herbal supplements that are known inhibitors or inducers of CYP3A4/5 and cannot be withdrawn prior to study treatment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
Sites / Locations
- Dana Farber Cancer Institute Dept. Onc
- Memorial Sloan Kettering Cancer Center Dept of Onc..
- Pfizer Investigative Site
- Pfizer Investigative Site
- Pfizer Investigative Site
- Pfizer Investigative Site
- Pfizer Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
AEB071 and MEK162 combined
MEK162 alone
Outcomes
Primary Outcome Measures
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Phase II: Progression Free Survival (PFS)
The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Secondary Outcome Measures
Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)
Serious adverse event (SAE) is defined as one of the following:
Is fatal or life-threatening
Results in persistent or significant disability/incapacity
Constitutes a congenital anomaly/birth defect
Is medically significant
Requires inpatient hospitalization or prolongation of existing hospitalization
Note that hospitalizations for the following reasons should not be reported as serious adverse events:
Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition
Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent
Social reasons and respite care in the absence of any deterioration in the patient's general condition
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Full Information
NCT ID
NCT01801358
First Posted
February 21, 2013
Last Updated
September 14, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01801358
Brief Title
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Official Title
A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
The trial was terminated for scientific reasons.
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed
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 treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveal Melanoma
Keywords
Melanoma,, melanoma of the eye,, uveal,, MEK162,, AEB071
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
AEB071 and MEK162 combined
Arm Title
Arm B
Arm Type
Experimental
Arm Description
MEK162 alone
Intervention Type
Drug
Intervention Name(s)
AEB071
Other Intervention Name(s)
Sotrastaurin
Intervention Description
Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)
Intervention Type
Drug
Intervention Name(s)
MEK162
Intervention Description
Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)
Primary Outcome Measure Information:
Title
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Description
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Time Frame
Cycle 1 (up to 28 days)
Title
Phase II: Progression Free Survival (PFS)
Description
The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Secondary Outcome Measure Information:
Title
Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)
Description
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)
Description
Serious adverse event (SAE) is defined as one of the following:
Is fatal or life-threatening
Results in persistent or significant disability/incapacity
Constitutes a congenital anomaly/birth defect
Is medically significant
Requires inpatient hospitalization or prolongation of existing hospitalization
Note that hospitalizations for the following reasons should not be reported as serious adverse events:
Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition
Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent
Social reasons and respite care in the absence of any deterioration in the patient's general condition
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Description
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Time Frame
Cycle 1 (up to 28 days)
Title
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)
Description
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.
Time Frame
Cycle 1 (up to 28 days)
Title
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)
Description
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.
PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Time Frame
Cycle 1 (up to 28 days)
Title
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)
Description
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Description
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)
Description
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)
Description
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.
Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.
Due to an enrollment halt, the Phase II part of the study was not conducted.
Time Frame
From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)
Title
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
Title
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
Title
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
Title
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 1)
Title
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
Title
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
Title
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)
Description
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Time Frame
Cycle 1 (Day 15)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Dana Farber Cancer Institute Dept. Onc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Dept of Onc..
City
New York
State/Province
New York
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigative Site
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Pfizer Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Pfizer Investigative Site
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Pfizer Investigative Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Pfizer Investigative Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
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