A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)
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ClinicalTrials.gov Identifier: NCT00848718 |
Recruitment Status :
Completed
First Posted : February 20, 2009
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Locally Advanced, Metastatic Solid Tumors |
Interventions |
Drug: MK-2206 Drug: docetaxel Drug: erlotinib Drug: carboplatin Drug: paclitaxel Drug: corticosteroid |
Enrollment | 77 |
Participant Flow
Recruitment Details | 77 participants were allocated to one of 3 treatment combinations with MK-2206 according to clinical presentation but 5 participants were not treated due to disease progression before initiation of treatment. |
Pre-assignment Details |
Arm/Group Title | MK-2206 45 mg QOD+Carboplatin+Paclitaxel | MK-2206 60 mg QOD+Carboplatin+Paclitaxel | MK-2206 90 mg Q3W+Carboplatin+Paclitaxel | MK-2206 135 mg Q3W+Carboplatin+Paclitaxel | MK-2206 200 mg Q3W+Carboplatin+Paclitaxel | MK-2206 45 mg QOD+Docetaxel 75 mg/m^2 | MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 45 mg QOD+Erlotinib 100 mg | MK-2206 45 mg QOD+Erlotinib 150 mg | MK-2206 135 mg QW+Erlotinib 100 mg | MK-2206 135 mg QW+Erlotinib 150 mg |
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Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle. |
Period Title: Overall Study | |||||||||||||
Started | 7 | 9 | 6 | 5 | 6 | 5 | 3 | 5 | 4 | 9 | 4 | 6 | 8 |
Treated | 6 [1] | 9 | 5 [1] | 5 | 6 | 5 | 3 | 4 [1] | 4 | 9 | 4 | 6 | 6 [2] |
Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Not Completed | 7 | 9 | 6 | 5 | 6 | 5 | 3 | 5 | 4 | 9 | 4 | 6 | 8 |
Reason Not Completed | |||||||||||||
Adverse Event | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 2 |
Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Physician Decision | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 1 |
Progressive disease before treatment | 1 | 5 | 1 | 3 | 4 | 4 | 2 | 1 | 2 | 7 | 3 | 6 | 2 |
Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Progressive disease during treatment | 3 | 0 | 3 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 |
[1]
1 participant was allocated but did not receive treatment due to progression of disease
[2]
2 participants were allocated but did not receive treatment due to progression of disease
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Baseline Characteristics
Arm/Group Title | MK-2206 45 mg QOD+Carboplatin+Paclitaxel | MK-2206 60 mg QOD+Carboplatin+Paclitaxel | MK-2206 90 mg Q3W+Carboplatin+Paclitaxel | MK-2206 135 mg Q3W+Carboplatin+Paclitaxel | MK-2206 200 mg Q3W+Carboplatin+Paclitaxel | MK-2206 45 mg QOD+Docetaxel 75 mg/m^2 | MK-2206 90 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 135 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 200 mg Q3W+Docetaxel 60 mg/m^2 | MK-2206 45 mg QOD+Erlotinib 100 mg | MK-2206 45 mg QOD+Erlotinib 150 mg | MK-2206 135 mg QW+Erlotinib 100 mg | MK-2206 135 mg QW+Erlotinib 150 mg | Total | |
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Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 60 mg administered PO on Days 1, 3, 5, and 7 in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 90 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 135 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 200 mg administered PO in combination with carboplatin AUC 6 and paclitaxel 200 mg/m^2 administered IV on Day 1 of each 21-day cycle. | Participants received MK-2206 45 mg administered PO on Days 1, 3, 5, and 7 in combination with Docetaxel 75 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 90 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 135 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 200 mg administered PO on Day 1 in combination with Docetaxel 60 mg/m^2 administered IV on Day 1 of each 21-day cycle. Participants also received an oral corticosteroid PO daily. | Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 45 mg administered PO every other day (Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19 and 21) in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 100 mg administered PO once every day of each 21-day cycle. | Participants received MK-2206 135 mg administered PO on Days 1, 8 and 15 in combination with Erlotinib 150 mg administered PO once every day of each 21-day cycle. | Total of all reporting groups | |
Overall Number of Baseline Participants | 7 | 9 | 6 | 5 | 6 | 5 | 3 | 5 | 4 | 9 | 4 | 6 | 8 | 77 | |
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All participants who were allocated to receive treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 7 participants | 9 participants | 6 participants | 5 participants | 6 participants | 5 participants | 3 participants | 5 participants | 4 participants | 9 participants | 4 participants | 6 participants | 8 participants | 77 participants | |
51.6 (15.3) | 58.4 (13.6) | 56.2 (10.4) | 63.6 (7.8) | 38.8 (12.4) | 57.4 (19.7) | 64.7 (12.0) | 57.4 (8.0) | 54.0 (9.4) | 61.6 (6.1) | 61.0 (6.4) | 55.7 (12.7) | 54.1 (10.9) | 56.2 (12.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 7 participants | 9 participants | 6 participants | 5 participants | 6 participants | 5 participants | 3 participants | 5 participants | 4 participants | 9 participants | 4 participants | 6 participants | 8 participants | 77 participants | |
Female |
4 57.1%
|
6 66.7%
|
2 33.3%
|
4 80.0%
|
1 16.7%
|
2 40.0%
|
1 33.3%
|
4 80.0%
|
3 75.0%
|
2 22.2%
|
1 25.0%
|
2 33.3%
|
4 50.0%
|
36 46.8%
|
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Male |
3 42.9%
|
3 33.3%
|
4 66.7%
|
1 20.0%
|
5 83.3%
|
3 60.0%
|
2 66.7%
|
1 20.0%
|
1 25.0%
|
7 77.8%
|
3 75.0%
|
4 66.7%
|
4 50.0%
|
41 53.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 7 participants | 9 participants | 6 participants | 5 participants | 6 participants | 5 participants | 3 participants | 5 participants | 4 participants | 9 participants | 4 participants | 6 participants | 8 participants | 77 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 16.7%
|
1 20.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 11.1%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
3 3.9%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
1 11.1%
|
0 0.0%
|
0 0.0%
|
1 16.7%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 2.6%
|
|
White |
7 100.0%
|
8 88.9%
|
6 100.0%
|
5 100.0%
|
4 66.7%
|
4 80.0%
|
3 100.0%
|
5 100.0%
|
4 100.0%
|
8 88.9%
|
4 100.0%
|
6 100.0%
|
8 100.0%
|
72 93.5%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
Outcome Measures
Adverse Events