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

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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

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: MEDI9090 Biological: Durvalumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Actual Study Start Date : August 9, 2016
Estimated Primary Completion Date : January 3, 2020
Estimated Study Completion Date : January 3, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: MEDI9090 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.




Primary Outcome Measures :
  1. Number of subjects reporting infusion related reactions [ Time Frame: First dose of study medication through 30 days after the first dose of study medication ]
  2. 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 ]

Secondary Outcome Measures :
  1. Individual MEDI9090 concentrations [ Time Frame: First dose of study medication through 3 months after the last dose of study medication ]
  2. Number of subjects reporting adverse events [ Time Frame: Screening through 3 months after last dose of study medication ]
  3. Number of subjects reporting serious adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  4. Number of subjects with vital sign abnormalities reported as adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]
  5. Number of subjects with ECG abnormalities reported as adverse events [ Time Frame: Screening through 3 months after the last dose of study medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900157


Locations
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United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85258
United States, California
Research Site
Los Angeles, California, United States, 90025
United States, Colorado
Research Site
Denver, Colorado, United States, 80218
United States, North Carolina
Research Site
Huntersville, North Carolina, United States, 28078
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Japan
Research Site
Koto-ku, Japan, 135-8550
Research Site
Sapporo-shi, Japan, 003-0804
Research Site
Sunto-gun, Japan, 411-8777
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC MedImmune LLC

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Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT02900157     History of Changes
Other Study ID Numbers: D4190C00055
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Keywords provided by MedImmune LLC:
Advanced Solid Tumor
Immunotherapy
MEDI9090
MEDI4736
Durvalumab
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents