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

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ClinicalTrials.gov Identifier: NCT03913455
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Astex Pharmaceuticals
Indiana University School of Medicine
Information provided by (Responsible Party):
Shadia Jalal, MD, Hoosier Cancer Research Network

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
Small Cell Lung Cancer Extensive-stage Small Cell Lung Cancer Drug: Guadecitabine Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Evaluating Efficacy and Safety of Hypomethylating Agent Guadecitabine in Combination With Carboplatin in Extensive Stage Small Cell Lung Cancer
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Carboplatin

Arm Intervention/treatment
Guadecitabine and Carboplatin
Each cycle = 28 days; Subjects receive 4 cycles
Drug: Guadecitabine
Guadecitabine 30 mg/m2 subcutaneously Days 1-5
Other Name: SGI-110

Drug: Carboplatin
Carboplatin AUC 4 IV Day 5
Other Name: Platinol




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 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 :
  1. Assess adverse events [ Time Frame: 2 years ]
    Occurrence of all treatment related toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  2. Objective Response Rate (ORR) [ Time Frame: 2 years ]
    ORR will include confirmed complete response (CR) + confirmed partial response (PR) and will be determined as per RECIST 1.1.

  3. Disease Control Rate (DCR) [ Time Frame: 2 years ]
    DCR defined as CR + PR + Stable Disease (SD) per RECIST 1.1

  4. Overall Survival (OS) [ Time Frame: 2 years ]
    OS as defined as the time from Day 1 of treatment until death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, age ≥ 18 years.
  • Histological or cytological diagnosis of extensive-stage small cell lung cancer. 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 a double-barrier method of birth control from the screening visit through 3 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913455


Contacts
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Contact: Shadia Jalal, MD, MBBS 1 317-274-3658 sjalal@iu.edu
Contact: Ahran Lee 317-634-5842 ext 14 Alee@hoosiercancer.org

Locations
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United States, Indiana
Indiana Univeristy Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Christina Glendenning    317-278-5601    cmnelson@iu.edu   
Principal Investigator: Shadia Jalal, MD         
IU Health Ball Memorial Cancer Center Recruiting
Muncie, Indiana, United States, 47303
Contact: Cathleen Carlos    765-751-5850    ccarlos@iuhealth.org   
Principal Investigator: Maitri Kalra, MD         
Sponsors and Collaborators
Shadia Jalal, MD
Astex Pharmaceuticals
Indiana University School of Medicine
Investigators
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Principal Investigator: Shadia Jalal, MD, MBBS Indiana University School of Medicine

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Responsible Party: Shadia Jalal, MD, Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT03913455     History of Changes
Other Study ID Numbers: HCRN LUN17-302
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Guadecitabine
Azacitidine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors