Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02978716
Status:
TERMINATED
Last Update Posted:
2022-03-23
First Post:
2016-11-18
Brief Title:
Trilaciclib G1T28 a CDK 46 Inhibitor in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer mTNBC
Sponsor:
G1 Therapeutics Inc
Organization:
G1 Therapeutics Inc
Study Overview
Official Title:
Phase 2 Study of the Safety Efficacy and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary Analysis and survival follow up completed per protocol Not stopped due to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was 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 carboplatin and gemcitabine GC therapy for participants with metastatic triple negative breast cancer
The study was an open-label and 102 participants were randomly assigned 111 fashion to 1 of the 3 following treatment groups
Group 1 GC therapy Days 1 and 8 of 21-day cycles only n34
Group 2 GC therapy Days 1 and 8 plus trilaciclib G1T28 on Days 1 and 8 of 21-day cycles n33
Group 3 GC therapy Days 2 and 9 plus trilaciclib G1T28 on Days 1 2 8 and 9 of 21-day cycles n35
The study included 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 study was an open-label and 102 participants were randomly assigned 111 fashion to 1 of the 3 following treatment groups
Group 1 GC therapy Days 1 and 8 of 21-day cycles only n34
Group 2 GC therapy Days 1 and 8 plus trilaciclib G1T28 on Days 1 and 8 of 21-day cycles n33
Group 3 GC therapy Days 2 and 9 plus trilaciclib G1T28 on Days 1 2 8 and 9 of 21-day cycles n35
The study included 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
Detailed Description:
The posted results represent the final results of Study G1T28-04 a Phase 2 study of the safety efficacy and pharmacokinetics of trilaciclib G1T28 in patients with locally recurrentmetastatic triple negative breast cancer receiving gemcitabine and carboplatin chemotherapy
The final myelopreservation efficacy results are reported from database lock 1 DBL1 data cut-off DCO date of 30 July 2018 Final anti-tumor efficacy ORR PFS and final summary exposure and safety data are reported from database lock 2 DBL2 DCO 28 June 2019 which occurred to support filing of the trilaciclib New Drug Application NDA Final overall survival OS data are reported from the final database lock which occurred on 17 July 2020 with a last patient last visit date of 28 February 2020
The final myelopreservation efficacy results are reported from database lock 1 DBL1 data cut-off DCO date of 30 July 2018 Final anti-tumor efficacy ORR PFS and final summary exposure and safety data are reported from database lock 2 DBL2 DCO 28 June 2019 which occurred to support filing of the trilaciclib New Drug Application NDA Final overall survival OS data are reported from the final database lock which occurred on 17 July 2020 with a last patient last visit date of 28 February 2020
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004466-26 | EUDRACT_NUMBER | None | None |