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Trial record 1 of 1 for:    NCT01248949
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A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248949
First Posted: November 25, 2010
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MedImmune LLC
Results First Submitted: December 2, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Advanced Solid Tumors
Advanced Recurrent Ovarian Tumors
Interventions: Drug: MEDI3617
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Carboplatin

  Participant Flow
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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
A total of 162 participants were screened, of which 46 did not meet eligibility criteria and were considered as screen failures; the remaining 116 participants entered into the study and treated with MEDI3617.

Reporting Groups
  Description
MEDI3617 SINGLE AGENT TOTAL Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.

Participant Flow:   Overall Study
    MEDI3617 SINGLE AGENT TOTAL   MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL   MEDI3617 + BEVACIZUMAB Q2W TOTAL   MEDI3617 + PACLITAXEL TOTAL   MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL
STARTED   42   16   38   13   7 
COMPLETED   9   3   1   3   3 
NOT COMPLETED   33   13   37   10   4 
Lost to Follow-up                2                2                2                1                0 
Withdrawal by Subject                5                3                11                3                1 
Death                22                7                21                6                2 
Alternative Therapy                1                0                0                0                0 
Alternative Therapy.                1                0                0                0                0 
Palliative Radiation To Brain Metastases                1                0                0                0                0 
Entered Hospice And Refused Follow Up                0                0                0                0                1 
Participant Went To Hospice                0                0                1                0                0 
Per Sponsor Request o Discontinue Drug                1                0                0                0                0 
Pi Decision Due To Declining Status                0                0                1                0                0 
Pi Discretion Due To Hospitalisation                0                1                0                0                0 
Lesion In ThoracicSpine Requires Therapy                0                0                1                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.
Safety population included all participants who receive any treatment with MEDI3617.

Reporting Groups
  Description
MEDI3617 SINGLE AGENT TOTAL Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
Total Total of all reporting groups

Baseline Measures
   MEDI3617 SINGLE AGENT TOTAL   MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL   MEDI3617 + BEVACIZUMAB Q2W TOTAL   MEDI3617 + PACLITAXEL TOTAL   MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   16   38   13   7   116 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.4  (12.4)   57.4  (11.9)   57.7  (11.2)   60.4  (12.7)   56.7  (12.3)   59.2  (11.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      27  64.3%      7  43.8%      18  47.4%      8  61.5%      5  71.4%      65  56.0% 
Male      15  35.7%      9  56.3%      20  52.6%      5  38.5%      2  28.6%      51  44.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLTs)   [ Time Frame: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1) ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1) ]

3.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)   [ Time Frame: From start of study drug administration up to 90 days after the last dose of MEDI3617 ]

4.  Primary:   Number of Participants With Laboratory Abnormalities Recorded as Adverse Events (AEs)   [ Time Frame: From start of study drug administration up to 90 days after the last dose of MEDI3617 ]

5.  Primary:   Number of Participants With Vital Sign Abnormalities Recorded as Adverse Events (AEs)   [ Time Frame: From start of study drug administration up to 90 days after the last dose of MEDI3617 ]

6.  Primary:   Number of Participants With Echocardiogram Abnormalities Recorded as Adverse Events (AEs)   [ Time Frame: From start of study drug administration up to 90 days after the last dose of MEDI3617 ]

7.  Primary:   Number of Participants With Electrocardiogram Abnormalities Recorded as Adverse Events (AEs)   [ Time Frame: From start of study drug administration up to 90 days after the last dose of MEDI3617 ]

8.  Primary:   Number of Participants With a Decline in Karnofsky Performance Status (KPS) of ≥ 20 Points at Worst Record On-study Compared With Baseline   [ Time Frame: From start of study drug administration up to 30 days after the last dose of MEDI3617 ]

9.  Secondary:   Maximum Observed Serum Concentration (Cmax) of MEDI3617   [ Time Frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose ]

10.  Secondary:   Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI3617   [ Time Frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose ]

11.  Secondary:   Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3617   [ Time Frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose ]

12.  Secondary:   Systemic Clearance (CL) of MEDI3617   [ Time Frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose ]

13.  Secondary:   Terminal Elimination Half Life (t1/2) of MEDI3617   [ Time Frame: Days 1, 2 (MEDI3617 single agent only), 4, 8, 15 (Cycle 1); Day 1 (Cycle 2 and every cycle after), Day 15 (MEDI3617 + bev Q2W and MEDI3617 + paclitaxel only, Cycle 2 and every cycle after); end of treatment; 30 days and 3 months post last dose ]

14.  Secondary:   Number of Participants With Positive Anti-Drug Antibody (ADA)   [ Time Frame: Presence of ADA to MEDI3617 were assessed prior to infusion with MEDI3617 on Day 1 of each dosing cycle, as well as the end of treatment, and 30 days, 3 months, and 6 months post last dose of MEDI3617 ]

15.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Time from the first dose of investigational product until end of study ]

16.  Secondary:   Time to Response (TTR)   [ Time Frame: Time from the first dose of investigational product until end of study ]

17.  Secondary:   Duration of Response (DOR)   [ Time Frame: Time from the first dose of investigational product until end of study ]

18.  Secondary:   Time to Progression (TTP)   [ Time Frame: Time from the first dose of investigational product until end of study ]

19.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Time from the first dose of investigational product until end of study ]

20.  Secondary:   Overall Survival (OS)   [ Time Frame: Time from the first dose of investigational product until death due to any cause ]

21.  Secondary:   Circulating Levels of Angiopoietin 2 (Ang2)   [ Time Frame: Prior to infusion on Cycle 4 and Cycle 5 ]


  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: Mohammed Dar, MD
Organization: MedImmune, LLC
phone: 301-398-0000
e-mail: information.center@astrazeneca.com



Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01248949     History of Changes
Other Study ID Numbers: CD-ON-MEDI3617-1043
First Submitted: November 23, 2010
First Posted: November 25, 2010
Results First Submitted: December 2, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017