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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 : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
G1 Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 3, 2015
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE October 5, 2015
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Dose Limiting Toxicity [ Time Frame: Days 1-21 of Cycle 1 ]
  • Treatment related adverse events (AE) [ Time Frame: Up to 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02514447 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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
  • Progression free survival (PFS) [ Time Frame: 24 Months ]
  • Overall survival (OS) [ Time Frame: 24 Month ]
  • Hematologic parameters [ Time Frame: Up to 20 weeks ]
    The following will be assessed: hemoglobin, hematocrit, white blood cells with differential and platelet counts
  • Tumor response based on RECIST, Version 1.1 [ Time Frame: Up to 20 weeks ]
  • Need for RBC and platelet transfusions [ Time Frame: Up to 20 weeks ]
  • Need for treatment with hematopoietic growth factors [ Time Frame: Day 22 ]
  • Incidence of chemotherapy dose reductions and dose interruptions overall [ Time Frame: Up to 20 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Pharmacokinetic profile for G1T28 and Topotecan [ Time Frame: Days 1 and 4 of Cycle 1 ]
    Blood samples for the determination of G1T28 and Topotecan
  • Progression free survival (PFS) [ Time Frame: 24 Months ]
  • Overall survival (OS) [ Time Frame: 24 Month ]
  • Hematologic parameters [ Time Frame: Up to 20 weeks ]
    The following will be assessed: hemoglobin, hematocrit, white blood cells with differential and platelet counts
  • Tumor response based on RECIST, Version 1.1 [ Time Frame: Up to 20 weeks ]
  • Need for RBC and platelet transfusions [ Time Frame: Up to 20 weeks ]
  • Need for treatment with hematopoietic growth factors [ Time Frame: Day 22 ]
  • Incidence of chemotherapy dose reductions and dose interruptions overall [ Time Frame: Up to 20 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
Official Title  ICMJE Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Trilaciclib
    Other Names:
    • G1T28
    • CDK 4/6 inhibitor
  • Drug: Placebos
  • Drug: Topotecan
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Trilaciclib
    • 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.
    Interventions:
    • Drug: Trilaciclib
    • 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.
    Interventions:
    • Drug: Placebos
    • Drug: Topotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
120
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
40
Estimated Study Completion Date  ICMJE January 2020
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Bosnia and Herzegovina,   Croatia,   North Macedonia,   Serbia,   Slovakia,   Slovenia,   United States
Removed Location Countries Macedonia, The Former Yugoslav Republic of
 
Administrative Information
NCT Number  ICMJE NCT02514447
Other Study ID Numbers  ICMJE G1T28-03
2016-004611-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party G1 Therapeutics, Inc.
Study Sponsor  ICMJE G1 Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Contact G1 Therapeutics, Inc.
PRS Account G1 Therapeutics, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP