Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Guadecitabine and Carboplatin Each cycle = 28 days; Subjects receive 4 cycles |
Drug: Guadecitabine
Guadecitabine 30 mg/m2 subcutaneously Days 1-5
Other Names:
Drug: Carboplatin
Carboplatin AUC 4 IV Day 5
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [2 years]
• PFS as defined as the time from Day 1 of treatment until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause, whichever occurs first.
Secondary Outcome Measures
- Assess adverse events [2 years]
Occurrence of all treatment related toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Objective Response Rate (ORR) [2 years]
ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.
- Disease Control Rate (DCR) [2 years]
DCR defined as CR + PR + Stable Disease (SD) per RECIST 1.1
- Overall Survival (OS) [2 years]
OS as defined as the time from Day 1 of treatment until death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects, age ≥ 18 years.
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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.
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Patient should not have received more than 1 prior line of chemotherapy (could have received immunotherapy which does not count as chemotherapy).
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ECOG PS 0-1
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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.
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Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:
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Hemoglobin ≥ 9.0 g/dL
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Absolute neutrophil count (ANC) ≥ 1,500/mm3
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Platelet count ≥ 100,000/mm3
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Total bilirubin ≤ 1.5 x upper limit of normal (ULN). For subjects with Gilbert's Disease, total bilirubin ≤ 3 x ULN
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ALT and AST ≤ 2.5 x ULN. For subjects with documented liver metastases, ALT and AST ≤ 5×ULN
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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.
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Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute/1.73 m2 as determined using the Cockcroft-Gault formula.
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Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.
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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:
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Platinum refractory disease defined as disease progression during first line platinum containing chemotherapy regimen. Progression following platinum based therapy is allowed.
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Prior therapy with a hypomethylating agent.
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Previously untreated (non-irradiated), symptomatic brain metastases. No prior treatment is required for non-symptomatic brain metastases. Previously treated symptomatic brain metastases are permitted.
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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.
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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.)
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Hypersensitivity to (IMP) or components of the study treatment regimen.
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Treated with any investigational drug within 3 weeks of first dose of study treatment.
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Pregnant or breastfeeding.
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Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana Univeristy Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 2 | IU Health Ball Memorial Cancer Center | Muncie | Indiana | United States | 47303 |
| 3 | University of Virginia Health System | Charlottesville | Virginia | United States | 22908 |
| 4 | University of Wisconsin, Clinical Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Shadia Jalal, MD
- Astex Pharmaceuticals, Inc.
- Indiana University School of Medicine
Investigators
- Principal Investigator: Shadia Jalal, MD, MBBS, Indiana University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HCRN LUN17-302