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G1T28 (CDK 4/6 Inhibitor) in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)

Information source: G1 Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: G1T28 + carboplatin/ etoposide (Drug); Placebo + carboplatin/ etoposide (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: G1 Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Clinical Contact, Study Director, Affiliation: G1 Therapeutics, Inc.

Overall contact:
G1Therapeutics Clinical Contact, Email: clinicalinfo@g1therapeutics.com

Summary

This is a study to investigate the potential clinical benefit of G1T28 in protecting the bone marrow and preserving the immune system when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 80 patients will be enrolled in the study.

Clinical Details

Official title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Dose Limiting Toxicity

Treatment related adverse events (AE)

Secondary outcome:

Pharmacokinetic profile for G1T28, Carboplatin and Etoposide

Progression free survival (PFS)

Overall survival (OS)

Hematologic parameters

Tumor response based on RECIST, Version 1.1

Need for RBC and platelet transfusions

Need for treatment with hematopoietic growth factors

Incidence of chemotherapy dose reductions and dose interruptions overall

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects aged ≥18 years

- Histologically or cytologically confirmed confirmed diagnosis of SCLC, including the

presence of neuroendocrine features by immunohistochemistry

- At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1. 1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

- Adequate organ function

Exclusion Criteria:

- Prior chemotherapy for extensive-stage SCLC

- Presence of symptomatic brain metastases requiring immediate treatment with radiation

therapy or steroids.

- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart

failure

- Known history of stroke or cerebrovascular accident within 6 months prior to

enrollment

- Other uncontrolled serious chronic disease or conditions that in the investigator's

opinion could affect compliance or follow-up in the protocol

- Concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to

enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)

- Receipt of any investigational medication within 4 weeks prior to enrollment

Locations and Contacts

G1Therapeutics Clinical Contact, Email: clinicalinfo@g1therapeutics.com

Genesis Cancer Center, Hot Springs, Arkansas 71913, United States; Recruiting
Laura Sellers, RN, Email: lsellers@genesiscancercenter.com
R. Timothy Webb, MD, Principal Investigator

University Cancer and Blood Center, LLC, Athens, Georgia 30607, United States; Recruiting
Jamie Hodgson, Phone: 706-353-2990, Ext: 279, Email: jhodgson@universitycancer.com
Petros Nikolanikos, MD, Principal Investigator

Center For Cancer and Blood Disorders, Bethesda, Maryland 20817, United States; Recruiting
Natalie Bongiorno, RN, Phone: 301-571-2016
Ralph Boccia, MD, Principal Investigator

Oklahoma University - Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma 73117, United States; Recruiting
Ingrid Block, Phone: 405-271-8001, Ext: 48160, Email: Ingrid-Block@ouhsc.edu
Raid Aljumaily, MD, Principal Investigator

Additional Information

Starting date: June 2015
Last updated: August 3, 2015

Page last updated: August 23, 2015

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