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SGI-110 Plus Durvalumab/Tremelimumab in SCLC

NCT03085849 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DRUG

Durvalumab

1500 mg IV on day 8 (flat dose) until progression

DRUG

Tremelimumab

75 mg IV on day 8 (flat dose) x 4 doses

DRUG

SGI-110

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

Sponsors & Collaborators

  • Catherine Shu

    lead OTHER

Principal Investigators

  • Catherine Shu, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2018-11-26
Completion
2018-11-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03085849 on ClinicalTrials.gov