Study of Azacitidine and Durvalumab in Advanced Solid Tumors

Sponsor
University Health Network, Toronto
Study ID
NCT02811497
Phase
PHASE2
Status
Completed

Conditions

  • Estrogen Receptor Positive and HER2 Negative Breast Cancer
  • Microsatellite Stable Colorectal Carcinoma
  • Platinum Resistant Epithelial Ovarian Cancer Type II

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a phase 2 study of investigational drug, durvalumab given in combination with azacitidine (CC-486). The main purpose of this phase 2 study is to assess the antitumor activity of azacitidine in combination with durvalumab patients with microsatellite stable colorectal carcinoma (MSS-CRC), platinum resistant epithelial ovarian cancer type II (PR-OC), and estrogen receptor positive and HER2 negative breast cancer.

Key Dates

Start date
Sep 30, 2016
Status verified
Mar 2021
Primary completion
Nov 8, 2018
Completion
Aug 4, 2020

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine and Durvalumab
    Azacitidine will be given by mouth at a fixed dose of 300 mg daily for 14 consecutive days of every 28 day cycle for 3 cycles. Durvalumab will be given intravenously (by vein) at a fixed dose of 1500 mg (over 1 hour) on Day 1 of every 28 day cycle for 12 months or until disease progression.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: 4 weeks ]

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