Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004)

This study has been terminated.
(This study was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00954512
First received: July 23, 2009
Last updated: January 11, 2016
Last verified: January 2016
Results First Received: November 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms
Interventions: Drug: Carboplatin
Drug: Epirubicin
Biological: Trastuzumab
Drug: Everolimus
Drug: Gemcitabine
Biological: Robatumumab
Biological: Cetuximab
Drug: Paclitaxel
Drug: Cisplatin
Drug: 5-FU
Drug: Erlotinib
Drug: Irinotecan
Drug: Folinic Acid

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
Regimen B: Carboplatin + Paclitaxel + Robatumumab Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
Regimen D: Trastuzumab + Robatumumab Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)

Participant Flow:   Overall Study
    Regimen A: FOLFIRI (± Cetuximab) + Robatumumab     Regimen B: Carboplatin + Paclitaxel + Robatumumab     Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab     Regimen D: Trastuzumab + Robatumumab     Regimen E: mTor Inhibitor (Everolimus) + Robatumumab     Regimen F: Gemcitabine (± Erlotinib) + Robatumumab  
STARTED     2     3     0     2     4     4  
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     2     3     0     2     4     4  
Withdrawal by Subject                 0                 0                 0                 0                 0                 1  
Adverse Event                 0                 0                 0                 0                 1                 2  
Physician Decision                 0                 1                 0                 1                 0                 0  
Symptomatic Deterioration                 0                 1                 0                 0                 2                 0  
Progression of Disease                 2                 1                 0                 1                 1                 1  



  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
Regimen A: FOLFIRI (± Cetuximab) + Robatumumab Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
Regimen B: Carboplatin + Paclitaxel + Robatumumab Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
Regimen D: Trastuzumab + Robatumumab Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
Regimen E: mTor Inhibitor (Everolimus) + Robatumumab Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
Regimen F: Gemcitabine (± Erlotinib) + Robatumumab Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
Total Total of all reporting groups

Baseline Measures
    Regimen A: FOLFIRI (± Cetuximab) + Robatumumab     Regimen B: Carboplatin + Paclitaxel + Robatumumab     Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab     Regimen D: Trastuzumab + Robatumumab     Regimen E: mTor Inhibitor (Everolimus) + Robatumumab     Regimen F: Gemcitabine (± Erlotinib) + Robatumumab     Total  
Number of Participants  
[units: participants]
  2     3     0     2     4     4     15  
Age  
[units: Years]
Mean (Standard Deviation)
  47.0  (2.8)     54.0  (4.4)         48.0  (2.8)     53.3  (13.5)     70.8  (3.0)     56.5  (11.4)  
Gender  
[units: Participants]
             
Female     2     3         2     1     3     11  
Male     0     0         0     3     1     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 2: Number of Participants With Each Type of Response Evaluation Criteria in Solid Tumors (RECIST)-Determined Overall Best Response   [ Time Frame: Up to ~30 days after the final dose of robatumumab (Up to ~14 months) ]

2.  Primary:   Part 1: Number of Participants Who Experienced One or More Adverse Events (AEs)   [ Time Frame: Up to ~30 days after the final dose of robatumumab (Up to ~14 months) ]


  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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00954512     History of Changes
Other Study ID Numbers: P04722
MK-7454-004 ( Other Identifier: Merck Protocol Number )
2009-011101-16 ( EudraCT Number )
Study First Received: July 23, 2009
Results First Received: November 18, 2015
Last Updated: January 11, 2016
Health Authority: United States: Food and Drug Administration