MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01235897
First received: November 4, 2010
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: July 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Advanced Solid Tumors
Tumors
Cancer
Interventions: Drug: MK-2206
Drug: Paclitaxel
Drug: Trastuzumab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled on the study between April 2011 and January 2013. This is a phase one study; the number enrolled was guided by ongoing toxicity assessment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
17 patients were initially enrolled; however, one participant experienced rapid progression of disease before receiving any study treatment.

Reporting Groups
  Description
MK-2206 MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel

Participant Flow:   Overall Study
    MK-2206  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
all subjects receiving study treatment were included in study analysis

Reporting Groups
  Description
MK-2206 MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel

Baseline Measures
    MK-2206  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ( Full Range )
  52  
  ( 31 to 78 )  
Gender  
[units: participants]
 
Female     14  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Best Disease Response by Response Evaluation Criteria in Solid Tumor (RECIST), Version 1.1   [ Time Frame: 60 days after dose inititation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
MTD was defined as a dose resulting in 3 or fewer DLTs in 11 patients, plus a cohort of 4 patients by a modified TPI dose escalation method. Based on interim toxicity data from other studies, study dose did not exceed 135mg weekly.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jo Chien, MD
Organization: University of California, San Francisco
phone: 415-885-7577
e-mail: crss@ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01235897     History of Changes
Other Study ID Numbers: 10998
Study First Received: November 4, 2010
Results First Received: July 29, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration