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

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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