Try our beta test site

Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Ohio State University
Dana-Farber Cancer Institute
Weill Medical College of Cornell University
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00645333
First received: March 24, 2008
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: MK-0752, Docetaxel, Pegfilgrastim

  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
Eligible subjects included men or women with metastatic (Stage IV)breast cancer, or with locally advanced breast cancer (Stages IIIA> 10cm, or stages IIIB and IIIC) that did not respond to first-line anthracycline-based chemotherapy.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There must b at least a 6 month interval since prior taxane therapy.

Reporting Groups
  Description
MK-0752 and Docetaxel MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.

Participant Flow:   Overall Study
    MK-0752 and Docetaxel
STARTED   30 
COMPLETED   30 
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.
No text entered.

Reporting Groups
  Description
MK-0752 and Docetaxel MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.

Baseline Measures
   MK-0752 and Docetaxel 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
 
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   5 
Gender 
[Units: Participants]
 
Female   30 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   30 
Metastatic sites (multiple sites possible) [1] 
[Units: Participants]
 
Bone   12 
Lung/Pleura   16 
Liver   13 
Lymph Nodes   11 
Skin   5 
Other   7 
[1] Metastatic sites at baseline. Patients may have more than one metastatic site at baseline and therefore the total numbers for all categories (all metastatic sites) may be greater than the overall number of baseline participants.
Number of Metastatic Sites 
[Units: Participants]
 
 4 
 6 
 6 
>=3   14 
Tumor Hormone Receptor Status 
[Units: Participants]
 
ER positive/or PgR positive   18 
ER negative and PgR negative   12 
HER-2/neu status 
[Units: Participants]
 
Negative   28 
Positive   2 
Prior Therapy For Metastatic Disease [1] 
[Units: Participants]
 
None   7 
Chemotherapy   7 
Hormonal Therapy   0 
Chemotherapy and Hormonal Therapy   16 
[1] Prior therapy for metastatic disease. Patients may have had more than one prior therapy and therefore the total numbers for all categories (all prior therapies) may be greater than the overall number of baseline participants.
Number of Prior Metastatic Chemotherapy Regimens [1] 
[Units: Participants]
 
 7 
 2 
2+   21 
[1] Number of prior metastatic chemotherapy regimens. Patients may have more than one prior metastatic chemotherapy regimen and therefore the total numbers for all categories (all prior metastatic chemotherapy regimens) may be greater than the overall number of baseline participants.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Limiting Toxicity (DLT)   [ Time Frame: first 21 days ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: Up to 3 years ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame During therapy and for 30 days after therapy completion
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
MK-0752 MK-0752 in escalating doses, orally days 1-3, followed by docetaxel 80 mg/m2 IV on day 8, and pegfilgrastim 6mg SQ day 9. Cycle repeated every 21 days.

Other Adverse Events
    MK-0752
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   30/30 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin   
# participants affected / at risk   11/30 (36.67%) 
# events   16 
Leukocytes   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Lymphopenia   
# participants affected / at risk   4/30 (13.33%) 
# events   5 
Platelets   
# participants affected / at risk   4/30 (13.33%) 
# events   5 
Cardiac disorders   
Cardiac Arrhythmia - Other (Specify)   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Eye disorders   
Dry eye syndrome   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Watering eyes   
# participants affected / at risk   6/30 (20.00%) 
# events   8 
Gastrointestinal disorders   
Abdominal pain   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Constipation   
# participants affected / at risk   6/30 (20.00%) 
# events   6 
Diarrhea   
# participants affected / at risk   10/30 (33.33%) 
# events   12 
GI - Other (Specify)   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Nausea   
# participants affected / at risk   15/30 (50.00%) 
# events   17 
Vomiting   
# participants affected / at risk   6/30 (20.00%) 
# events   6 
General disorders   
Edema limbs   
# participants affected / at risk   5/30 (16.67%) 
# events   6 
Fatigue   
# participants affected / at risk   20/30 (66.67%) 
# events   26 
Fever   
# participants affected / at risk   7/30 (23.33%) 
# events   10 
Pain - Other   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Sweating   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Immune system disorders   
Allergic reaction   
# participants affected / at risk   4/30 (13.33%) 
# events   6 
Infections and infestations   
Skin infection   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Investigations   
Alanine aminotransferase increased   
# participants affected / at risk   5/30 (16.67%) 
# events   9 
Alkaline phosphatase increased   
# participants affected / at risk   8/30 (26.67%) 
# events   12 
Aspartate aminotransferase increased   
# participants affected / at risk   7/30 (23.33%) 
# events   13 
Metabolism and nutrition disorders   
Anorexia   
# participants affected / at risk   7/30 (23.33%) 
# events   7 
Hyperglycemia   
# participants affected / at risk   10/30 (33.33%) 
# events   19 
Hypoalbuminemia   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Hypocalcemia   
# participants affected / at risk   9/30 (30.00%) 
# events   10 
Hypokalemia   
# participants affected / at risk   9/30 (30.00%) 
# events   12 
Musculoskeletal and connective tissue disorders   
Back pain   
# participants affected / at risk   5/30 (16.67%) 
# events   6 
Bone pain   
# participants affected / at risk   6/30 (20.00%) 
# events   7 
Joint pain   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Nervous system disorders   
Hand-and-foot syndrome   
# participants affected / at risk   7/30 (23.33%) 
# events   10 
Headache   
# participants affected / at risk   4/30 (13.33%) 
# events   5 
Peripheral sensory neuropathy   
# participants affected / at risk   8/30 (26.67%) 
# events   13 
Taste alteration   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Psychiatric disorders   
Depression   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Insomnia   
# participants affected / at risk   5/30 (16.67%) 
# events   5 
Renal and urinary disorders   
Urinary tract infection   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Reproductive system and breast disorders   
Breast pain   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Respiratory, thoracic and mediastinal disorders   
Bronchitis   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Cough   
# participants affected / at risk   6/30 (20.00%) 
# events   7 
Dyspnea   
# participants affected / at risk   4/30 (13.33%) 
# events   7 
Nasal congestion   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Pharyngolaryngeal pain   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Pleural effusion   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
Upper respiratory infection   
# participants affected / at risk   4/30 (13.33%) 
# events   5 
Skin and subcutaneous tissue disorders   
Alopecia   
# participants affected / at risk   7/30 (23.33%) 
# events   8 
Dermatology/Skin - Other (Specify)   
# participants affected / at risk   5/30 (16.67%) 
# events   6 
Dry skin   
# participants affected / at risk   3/30 (10.00%) 
# events   3 
Nail changes   
# participants affected / at risk   10/30 (33.33%) 
# events   11 
Rash   
# participants affected / at risk   5/30 (16.67%) 
# events   7 
Vascular disorders   
Hot flashes   
# participants affected / at risk   2/30 (6.67%) 
# events   2 
* Events were collected by non-systematic assessment



  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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anne F. Schott, MD
Organization: University of Michigan
phone: 1-800-865-1125
e-mail: canceranswerline@umich.edu


Publications of Results:

Responsible Party: Ann Schott, MD, University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT00645333     History of Changes
Other Study ID Numbers: UMCC 2006.119
Study First Received: March 24, 2008
Results First Received: August 9, 2013
Last Updated: February 24, 2014