A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours

Part of paid clinical trials in Chicago, Illinois.

Sponsor
AstraZeneca
Study ID
NCT02586987
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase I, open-label, multi-centre, drug combination study of double and triple combination oral selumetinib (AZD6244 Hyd-sulfate) plus intravenous (IV) MEDI4736 and oral selumetinib plus IV MEDI4736 and IV tremelimumab in patients with advanced solid tumours.

Key Dates

Start date
Dec 28, 2015
Status verified
Nov 2019
Primary completion
Jul 25, 2018
Completion
Sep 20, 2019

Study Design

Enrollment
58 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation: Selumetinib+MEDI4736
    An oral formulation of selumetinib will be administered in combination with an IV dose of MEDI4736. 4 cohorts of double combination (Selumetinib+MEDI4736). The decision to escalate to the next dose level/cohort will be made by the Safety Review Committee (SRC) following the completion of the dose limiting toxicity (DLT) assessment period for at least 3 evaluable patients in each cohort.
  • Experimental: Mandatory paired biopsy expansion cohort: Selumetinib+MEDI4736
    One or more independent mandatory paired biopsy expansion cohorts for double combination treatment will start after safety and tolerability have been established for the relevant dose. It will be tumour-type specific for double combination, the tumor type will be determined from emerging data.
  • Experimental: Dose escalation: Selumetinib+MEDI4736+tremelimumab
    An oral formulation of selumetinib will be administered in combination with an IV dose of MEDI4736 and an IV dose of tremelimumab. For triple combination treatment, the starting dose of selumetinib (DL1) will be determined by the SRC based on emerging data from dose escalation cohorts of double combination treatment.
  • Experimental: Mandatory paired biopsy expansion cohort: triple combination
    One or more independent mandatory paired biopsy expansion cohorts for triple combination treatment will start after safety and tolerability have been established for the relevant dose. It will be tumour-type specific for triple combination, the tumor type will be determined from emerging data.

Primary Outcome Measure

Safety and tolerability of Selumetinib in combination with MEDI4736, and in combination with MEDI4736+ tremelimumab by assessment of Adverse Events [ Time Frame: From screening until approximately 30 days after last dose of study drug at disease progression ]

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteChicagoIllinois60637-
Research SiteBostonMassachusetts02215-
Research SiteLas VegasNevada89169-3321-
Research SiteNew BrunswickNew Jersey08901-
Research SiteCharlotteNorth Carolina28204-
Research SitePittsburghPennsylvania15232-

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