A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.

Part of paid clinical trials in Newnan, Georgia.

Sponsor
AstraZeneca
Study ID
NCT02734004
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Breast
  • Gastric Cancers
  • Ovarian
  • SCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

Key Dates

First listed
Apr 12, 2016
Start date
Mar 17, 2016
Status verified
Jul 2026
Primary completion
Sep 17, 2021
Completion
Sep 17, 2026

Study Design

Enrollment
264 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1
  • Experimental: Arm 2
    Includes 2nd stage cohorts (modules 5 \& 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1
  • Experimental: Arm 3
    Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1

Primary Outcome Measure

Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12 [ Time Frame: RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteNewnanGeorgia30265-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02114-
Research SiteDetroitMichigan48202-
Research SiteSt LouisMissouri63110-
Research SiteHilliardOhio43026-
Research SitePhiladelphiaPennsylvania19104-

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