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

NCT ID: NCT03913455

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2022-02-02

Brief 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

Small Cell Lung Cancer; Extensive-stage Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guadecitabine and Carboplatin

Each cycle = 28 days; Subjects receive 4 cycles

Group Type: OTHER

Guadecitabine

Intervention Type: DRUG

Guadecitabine 30 mg/m2 subcutaneously Days 1-5

Carboplatin

Intervention Type: DRUG

Carboplatin AUC 4 IV Day 5

Interventions

Guadecitabine

Guadecitabine 30 mg/m2 subcutaneously Days 1-5

Intervention Type: DRUG

Carboplatin

Carboplatin AUC 4 IV Day 5

Intervention Type: DRUG

Other Intervention Names

SGI-110; Platinol

Eligibility Criteria

Inclusion Criteria

• Male or female subjects, age ≥ 18 years.
• Histological or cytological diagnosis of small cell lung cancer. Subjects must have extensive-stage disease is defined as disease beyond the ipsilateral hemithorax, mediastinum and ipsilateral supraclavicular area and including malignant pleural or pericardial effusion or hematogenous metastases.
• Patient should not have received more than 1 prior line of chemotherapy (could have received immunotherapy which does not count as chemotherapy).
• ECOG PS 0-1
• Measurable disease as per RECIST v1.1. Subjects may have bone-only disease. NOTE: Bone-only subjects are eligible if their disease can be documented/evaluated by bone scans, CT or MRI. Their disease will be assessed using MD Anderson criteria. NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation.
• Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:

• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN). For subjects with Gilbert's Disease, total bilirubin ≤ 3 x ULN
• ALT and AST ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5×ULN
• International Normalized Ratio (INR) ≤1.5, if not therapeutically anticoagulated. Subjects who are being therapeutically anticoagulated may be included provided that the anticoagulation regimen is stable and closely monitored.
• Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute/1.73 m2 as determined using the Cockcroft-Gault formula.
• Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.
• Male and female subjects of child- bearing potential must agree to use an effective method of birth control from the screening visit through 6 months after the last dose of study drug.

Exclusion Criteria

• Platinum refractory disease defined as disease progression during first line platinum containing chemotherapy regimen. Progression following platinum based therapy is allowed.
• Prior therapy with a hypomethylating agent.
• Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain metastases are permitted.
• Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and/or their compliance with the protocol.
• Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV/AIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.)
• Hypersensitivity to (IMP) or components of the study treatment regimen.
• Treated with any investigational drug within 3 weeks of first dose of study treatment.
• Pregnant or breastfeeding.
• Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astex Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Indiana University School of Medicine

OTHER

Sponsor Role: collaborator

Shadia Jalal, MD

OTHER

Sponsor Role: lead

Responsible Party

Shadia Jalal, MD

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shadia Jalal, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana Univeristy Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

IU Health Ball Memorial Cancer Center

Muncie, Indiana, United States

University of Virginia Health System

Charlottesville, Virginia, United States

University of Wisconsin, Clinical Cancer Center

Milwaukee, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HCRN LUN17-302

Identifier Type: -

Identifier Source: org_study_id