MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies
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|ClinicalTrials.gov Identifier: NCT01235897|
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : November 19, 2013
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Tumors Cancer||Drug: MK-2206 Drug: Paclitaxel Drug: Trastuzumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Dose-escalation Trial of the AKT Inhibitor MK2206 in Combination With Weekly Paclitaxel With or Without Trastuzumab|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||November 2013|
|Experimental: Maximum tolerated dose||
Different dose levels of MK-2206 will studied, and co-administered with paclitaxel and trastuzumab. MK-2206 will be given orally with a starting dose of 135 mg weekly
80 mg/m2 weekly - paclitaxel
2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab
Other Name: Herceptin
- Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose of MK-2206 Administered Weekly in Combination With Weekly Paclitaxel 80 mg/m^2 and Trastuzumab 2 mg/m^2 [ Time Frame: 30 days from initiation of dose ]The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-ﬁnding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.
- Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1 [ Time Frame: 60 days after dose inititation ]
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Stable Disease (SD): Neither sufﬁcient shrinkage to qualify for PR nor sufﬁcient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Non-PR/Non-PD: clinical response of chest wall disease not evaluable by RECIST
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): NCT01235897
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Jo Chien, MD||University of California, San Francisco|