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Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514447
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
G1 Therapeutics, Inc.

Study Description
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Brief Summary:

This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for 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. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Trilaciclib Drug: Placebos Drug: Topotecan Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
Actual Study Start Date : October 5, 2015
Actual Primary Completion Date : September 28, 2018
Estimated Study Completion Date : July 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Trilaciclib (G1T28) + Topotecan
All patients in Part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy, topotecan. Patients will have PK assessment completed on days 1 and 4 in cycle 1 only. All patients will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
 Drug: Trilaciclib
Other Names:
  • G1T28
  • CDK 4/6 inhibitor

Drug: Topotecan
Experimental: Trilaciclib (G1T28) + Topotecan -PART 2
All patients in Part 2 will be randomized 2:1 to receive trilaciclib (G1T28) to be administered prior to standard chemotherapy, topotecan. Patients will have limited PK assessments completed on day 4 in cycle 1 only. All patients will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
 Drug: Trilaciclib
Other Names:
  • G1T28
  • CDK 4/6 inhibitor

Drug: Topotecan
Experimental: Placebo + Topotecan -PART 2
All patients in Part 2 will be randomized 1:2 to receive placebo administered prior to standard chemotherapy, topotecan. Patients will have limited PK assessments completed on day 4 in cycle 1 only. All patients will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
 Drug: Placebos
Drug: Topotecan


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Days 1-21 of Cycle 1 ]
  2. Treatment related adverse events (AE) [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile for Trilaciclib (G1T28) and Topotecan [ Time Frame: Days 1 and 4 of Cycle 1 ]
    Blood samples for the determination of trilaciclib (G1T28) and topotecan

  2. Progression free survival (PFS) [ Time Frame: 24 Months ]
  3. Overall survival (OS) [ Time Frame: 24 Month ]
  4. Hematologic parameters [ Time Frame: Up to 20 weeks ]
    The following will be assessed: hemoglobin, hematocrit, white blood cells with differential and platelet counts

  5. Tumor response based on RECIST, Version 1.1 [ Time Frame: Up to 20 weeks ]
  6. Need for RBC and platelet transfusions [ Time Frame: Up to 20 weeks ]
  7. Need for treatment with hematopoietic growth factors [ Time Frame: Day 22 ]
  8. Incidence of chemotherapy dose reductions and dose interruptions overall [ Time Frame: Up to 20 weeks ]

Eligibility Criteria
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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 aged ≥18 years
  • Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
  • Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy
  • At least 1 target lesion that is measurable by RECIST, Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
  • Adequate organ function

Exclusion Criteria:

  • 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 2 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 2 weeks prior to enrollment
  • History of topotecan treatment for SCLC
Contacts and Locations
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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): NCT02514447


Locations
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Sponsors and Collaborators
G1 Therapeutics, Inc.
Investigators
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Study Director: Clinical Contact G1 Therapeutics, Inc.
More Information
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Responsible Party: G1 Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02514447    
Other Study ID Numbers: G1T28-03
2016-004611-13 ( EudraCT Number )
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: February 10, 2020
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
Keywords provided by G1 Therapeutics, Inc.:
SCLC
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
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents