SGI-110 Plus Durvalumab/Tremelimumab in SCLC

Part of paid clinical trials in New York, New York.

Sponsor
Catherine Shu
Study ID
NCT03085849
Phase
PHASE1
Status
Completed

Conditions

  • Extensive-stage Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    1500 mg IV on day 8 (flat dose) until progression
  • Tremelimumab — DRUG
    75 mg IV on day 8 (flat dose) x 4 doses
  • SGI-110 — DRUG
    SC daily for 5 days (days 1-5) until progression or toxicity Dose escalation scheme: Dose level -1 - SGI-110 20 mg/m2 SC daily; Dose level 0 - SGI-110 30 mg/m2 SC daily; Dose level 1 - SGI-110 45 mg/m2 SC daily; and SGI-110 given on days 1-5 of every 28 day cycle

Study Details

The purpose of this study is to determine if a combination of investigational agents is safe to give to people with small cell lung cancer (SCLC) after standard chemotherapy has been attempted. Subjects enrolled in this trial will receive 3 investigational drugs: SGI-110 (guadecitabine), durvalumab (MEDI4736) and tremelimumab.

Key Dates

First listed
Mar 21, 2017
Start date
Dec 15, 2017
Status verified
Dec 2018
Primary completion
Nov 26, 2018
Completion
Nov 26, 2018

Study Design

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

Arms

  • Experimental: Treatment
    Subjects with ES-SCLC, progressive after platinum-based first-line chemotherapy will receive SGI-110 followed by combined durvalumab plus tremelimumab. 1. Dose escalation phase: 6-12 patients 2. MTD expansion cohort: 10 patients

Primary Outcome Measure

Maximum tolerated dose (MTD) of SGI-110 [ Time Frame: Approximately 24 to 48 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By research site
Columbia University Medical Center· New York, NY

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