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Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

NCT03913455 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-20

Study results available
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Summary

This is a phase II, open-label, single arm, single-stage study. Both, chemo-sensitive and chemo-resistant patients will be enrolled and treated with 4 cycles of combination of Guadecitabine and carboplatin

Conditions

Interventions

DRUG

Guadecitabine

Guadecitabine 30 mg/m2 subcutaneously Days 1-5

DRUG

Carboplatin

Carboplatin AUC 4 IV Day 5

Sponsors & Collaborators

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Indiana University School of Medicine

    collaborator OTHER

  • Shadia Jalal, MD

    lead OTHER

Principal Investigators

  • Shadia Jalal, MD, MBBS · Indiana University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2021-04-14
Completion
2022-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03913455 on ClinicalTrials.gov