A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer

Shadia Jalal, MD4 sites in 1 country24 target enrollmentJune 6, 2019

ConditionsSmall Cell Lung Cancer Extensive-stage Small Cell Lung Cancer

InterventionsGuadecitabine Carboplatin

DrugsGuadecitabine Carboplatin

Overview

Phase: Phase 2
Intervention: Guadecitabine
Conditions: Small Cell Lung Cancer
Sponsor: Shadia Jalal, MD
Enrollment: 24
Locations: 4
Primary Endpoint: Progression Free Survival (PFS)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 6, 2019

End Date

February 2, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shadia Jalal, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Shadia Jalal, MD

Sponsor-Investigator

Hoosier Cancer Research Network

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.
•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

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.

Arms & Interventions

Guadecitabine and Carboplatin

Each cycle = 28 days; Subjects receive 4 cycles

Intervention: Guadecitabine

Guadecitabine and Carboplatin

Each cycle = 28 days; Subjects receive 4 cycles

Intervention: Carboplatin

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: Time of treatment start until the criteria for disease progression or death. Up to a maximum of 7 months.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.

Secondary Outcomes

Objective Response Rate (ORR)(Up to a maximum of 7 months)
Disease Control Rate (DCR)(Up to a maximum of 7 months)
Adverse Events(AEs had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 5 months)
Overall Survival (OS)(Time of treatment start until death or date of last contact, up to a maximum of 16 months.)