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A Dose-escalation Study of MK-8776 (SCH 900776) With and Without Gemcitabine in Participants With Solid Tumors or Lymphoma (MK-8776-002/P05248)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779584
First received: October 22, 2008
Last updated: April 5, 2017
Last verified: April 2017
Results First Received: February 2, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms
Interventions: Drug: MK-8776
Drug: Gemcitabine

  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
MK-8776 10mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 10 mg/m^2 given as monotherapy as an intravenous (IV) infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 20mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 40mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 80mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 112mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 200mg+Gemcitabine 1000mg/m^2 Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.

Participant Flow:   Overall Study
    MK-8776 10mg/m^2+Gemcitabine 800mg/m^2   MK-8776 20mg/m^2+Gemcitabine 800mg/m^2   MK-8776 40mg/m^2+Gemcitabine 800mg/m^2   MK-8776 80mg/m^2+Gemcitabine 800mg/m^2   MK-8776 112mg/m^2+Gemcitabine 800mg/m^2   MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 200mg+Gemcitabine 1000mg/m^2
STARTED   3   3   7   6   7   6   8   3   2 
Treated   3   3   7   6   7   4   8   3   2 
COMPLETED   0   0   0   0   0   0   0   0   0 
NOT COMPLETED   3   3   7   6   7   6   8   3   2 
Protocol Violation                0                0                0                0                0                1                0                0                0 
Withdrawal by Subject                1                1                2                0                0                2                1                0                0 
Lost to Follow-up                0                0                0                0                1                0                0                0                0 
Progression of Disease                0                1                2                6                5                1                4                2                1 
Adverse Event                1                0                2                0                0                0                2                1                1 
Symptomatic Deterioration                1                1                1                0                0                1                1                0                0 
Ongoing in Study                0                0                0                0                1                1                0                0                0 



  Baseline Characteristics
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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-8776 10mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 10 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 20mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 20 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 40mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 40 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 80mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 112mg/m^2+Gemcitabine 800mg/m^2 Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 800 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 80 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 112 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2 Participants received MK-8776 150 mg/m^2 given as monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
MK-8776 200mg+Gemcitabine 1000mg/m^2 Participants received MK-8776 200 mg given as a flat dose monotherapy as an IV infusion on Cycle 0 Day 1 and as combination therapy with gemcitabine 1000 mg/m^2 starting with Cycle 1 on Days 1 and 8 of a 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
   MK-8776 10mg/m^2+Gemcitabine 800mg/m^2   MK-8776 20mg/m^2+Gemcitabine 800mg/m^2   MK-8776 40mg/m^2+Gemcitabine 800mg/m^2   MK-8776 80mg/m^2+Gemcitabine 800mg/m^2   MK-8776 112mg/m^2+Gemcitabine 800mg/m^2   MK-8776 80mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 112mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 150mg/m^2+Gemcitabine 1000mg/m^2   MK-8776 200mg+Gemcitabine 1000mg/m^2   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   7   6   7   6   8   3   2   45 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (16.0)   54.3  (8.6)   64.0  (16.1)   55.5  (5.0)   51.1  (5.7)   59.0  (13.4)   59.9  (9.1)   69.3  (5.5)   69.0  (8.5)   58.8  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      2  66.7%      0   0.0%      2  28.6%      2  33.3%      4  57.1%      2  33.3%      3  37.5%      1  33.3%      2 100.0%      18  40.0% 
Male      1  33.3%      3 100.0%      5  71.4%      4  66.7%      3  42.9%      4  66.7%      5  62.5%      2  66.7%      0   0.0%      27  60.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) During Cycle 0 and Cycle 1 Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v 3.0)   [ Time Frame: Through Cycle 0 and Cycle 1 (Up to 42 days) ]

2.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to approximately 72 weeks (Up to approximately 6 weeks after last dose of study treatment) ]

3.  Primary:   Number of Participants Who Discontinued Study Treatment Due to an AE   [ Time Frame: Up to approximatey 66 weeks ]

4.  Secondary:   MK-8776 Maximum Plasma Concentration (Cmax)   [ Time Frame: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion ]

5.  Secondary:   MK-8776 Area Under the Curve of the Plasma Concentration Versus Time From Time Zero to the Time of the Last Analytically Quantifiable Concentration (AUC0-last)   [ Time Frame: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion ]

6.  Secondary:   Time of MK-8776 Cmax (Tmax)   [ Time Frame: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion ]

7.  Secondary:   MK-8776 Terminal Phase Half-Life (t1/2)   [ Time Frame: At end of infusion of MK-8776 (Cycle 0) or gemcitabine (Cycle 1), and at 0.25, 1, 3, 6, 8, 24 and 48 hours after completion of MK-8776 infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00779584     History of Changes
Other Study ID Numbers: P05248
MK-8776-002 ( Other Identifier: Merck Protocol Number )
Study First Received: October 22, 2008
Results First Received: February 2, 2017
Last Updated: April 5, 2017