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Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors

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.
 
ClinicalTrials.gov Identifier: NCT02900157
Recruitment Status : Active, not recruiting
First Posted : September 14, 2016
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE September 2, 2016
First Posted Date  ICMJE September 14, 2016
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE August 9, 2016
Estimated Primary Completion Date January 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
  • Number of subjects reporting infusion related reactions [ Time Frame: First dose of study medication through 30 days after the first dose of study medication ]
  • Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090 [ Time Frame: First dose of study medication through 6 months after the last dose of study medication ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02900157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
  • Individual MEDI9090 concentrations [ Time Frame: First dose of study medication through 3 months after the last dose of study medication ]
  • Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after last dose of study medication ]
  • Number of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects with vital sign abnormalities reported as adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  • Number of subjects with ECG abnormalities reported as adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Brief Summary This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Biological: MEDI9090
    MEDI9090 will be administered by IV infusion
  • Biological: Durvalumab
    Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
Study Arms  ICMJE Experimental: MEDI9090
Interventions:
  • Biological: MEDI9090
  • Biological: Durvalumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
42
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2016)
30
Estimated Study Completion Date  ICMJE January 3, 2020
Estimated Primary Completion Date January 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects
  • 18 years and older
  • Must have histologic documentation of advanced solid tumors
  • Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option

Exclusion Criteria:

  • Concurrent enrollment in another clinical study
  • Prior participation in clinical studies that include durvalumab alone or in combination
  • Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02900157
Other Study ID Numbers  ICMJE D4190C00055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP