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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01577745
First received: April 5, 2012
Last updated: March 21, 2017
Last verified: March 2017
Results First Received: January 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Solid Tumors
Intervention: Biological: MEDI0639

  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
A total of 58 participants were screened at 7 sites in the United States of America (USA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 58 participants were screened for this study, of which 25 participants were enrolled and received study treatment.

Reporting Groups
  Description
MEDI0639 Cohort 1 Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 2 Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 3 Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 4 Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 5 Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 6 Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.

Participant Flow:   Overall Study
    MEDI0639 Cohort 1   MEDI0639 Cohort 2   MEDI0639 Cohort 3   MEDI0639 Cohort 4   MEDI0639 Cohort 5   MEDI0639 Cohort 6
STARTED   3   3   3   6   5   5 
COMPLETED   0   0   1   0   0   1 
NOT COMPLETED   3   3   2   6   5   4 
Withdrawal by Subject                0                1                0                3                2                0 
Death                3                2                2                1                1                3 
Physician Decision                0                0                0                1                1                0 
Lost to Follow-up                0                0                0                0                0                1 
Alternative Therapy                0                0                0                1                1                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.
Safety Population included all participants who received at least one dose of MEDI0639.

Reporting Groups
  Description
MEDI0639 Cohort 1 Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 2 Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 3 Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 4 Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 5 Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
MEDI0639 Cohort 6 Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
Total Total of all reporting groups

Baseline Measures
   MEDI0639 Cohort 1   MEDI0639 Cohort 2   MEDI0639 Cohort 3   MEDI0639 Cohort 4   MEDI0639 Cohort 5   MEDI0639 Cohort 6   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   6   5   5   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.7  (14.0)   57.3  (22.5)   67.7  (13.7)   62.2  (9.3)   62.2  (5.2)   62.6  (10.8)   61.6  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      0   0.0%      3 100.0%      1  33.3%      3  50.0%      3  60.0%      3  60.0%      13  52.0% 
Male      3 100.0%      0   0.0%      2  66.7%      3  50.0%      2  40.0%      2  40.0%      12  48.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      1  33.3%      1  33.3%      0   0.0%      0   0.0%      1  20.0%      0   0.0%      3  12.0% 
Not Hispanic or Latino      2  66.7%      2  66.7%      3 100.0%      6 100.0%      4  80.0%      5 100.0%      22  88.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  33.3%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   4.0% 
White      3 100.0%      2  66.7%      3 100.0%      6 100.0%      5 100.0%      5 100.0%      24  96.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of MEDI0639   [ Time Frame: From the first dose of MEDI0639 to 21 days after the first dose ]

2.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs)   [ Time Frame: From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months. ]

3.  Primary:   Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)   [ Time Frame: From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years. ]

4.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters   [ Time Frame: From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months. ]

5.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination   [ Time Frame: From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months. ]

6.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations   [ Time Frame: From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months. ]

7.  Primary:   Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations   [ Time Frame: From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months. ]

8.  Secondary:   Area Under the Concentration‑Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639   [ Time Frame: Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1 ]

9.  Secondary:   Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639   [ Time Frame: Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1 ]

10.  Secondary:   Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639   [ Time Frame: Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1 ]

11.  Secondary:   Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639   [ Time Frame: Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1 ]

12.  Secondary:   Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639   [ Time Frame: On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months. ]

13.  Secondary:   Percentage of Participants With Best Overall Response   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

14.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

15.  Secondary:   Percentage of Participants With Disease Control   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

16.  Secondary:   Time to Response   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

17.  Secondary:   Duration of Response (DR)   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

18.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]

19.  Secondary:   Overall Survival   [ Time Frame: From study entry through the end of the study. Maximum time frame across participants was 4 years. ]


  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
OMs relationship modulation of DLL4-Notch signaling pathway in tumor and clinical response analysis was not conducted due to low number of evaluable tumor samples and low response rate. Study was terminated early due to lack of clinical activity.


  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: Mohammed Dar
Organization: MedImmune, LLC
phone: 301-398-1008
e-mail: information.center@astrazeneca.com



Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01577745     History of Changes
Other Study ID Numbers: CD-ON-MEDI0639-1078
Study First Received: April 5, 2012
Results First Received: January 23, 2017
Last Updated: March 21, 2017