G1 THERAPEUTICS, INC. Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2024-01-10: Study NCT06027268; Company role Collaborator; Phase Phase 2; Status Active not recruiting.
- 2022-10-12: Study NCT05578326; Company role Collaborator; Phase Phase 2; Status Recruiting.
- 2022-03-03: Study NCT05112536; Company role Lead sponsor; Phase Phase 2; Status Completed.
- 2021-12-08: Study NCT05113966; Company role Lead sponsor; Phase Phase 2; Status Terminated.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2024-01-10 | NCT06027268 Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer | Collaborator Lead: Wake Forest University Health Sciences | Phase 2 | Active not recruiting | Metastatic Triple-Negative Breast Cancer | 36 | 2027-08 |
| 2022-10-12 | NCT05578326 Study of Trilaciclib and Lurbinectidin | Collaborator Lead: UNC Lineberger Comprehensive Cancer Center | Phase 2 | Recruiting | Lung Cancer; Small-cell Lung Cancer | 30 | 2028-12-25 |
| 2022-03-03 | NCT05112536 Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer | Lead sponsor | Phase 2 | Completed Results posted | Triple Negative Breast Cancer; Breast Cancer | 24 | 2023-03-13 |
| 2021-12-08 | NCT05113966 Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer | Lead sponsor | Phase 2 | Terminated Results posted | Triple Negative Breast Cancer | 30 | 2024-06-13 |
| 2021-08-11 | NCT05071703 Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study | Collaborator Lead: Jiangsu Simcere Pharmaceutical Co., Ltd. | Phase 4 | Completed | Extensive-stage Small-cell Lung Cancer | 30 | 2022-11-30 |
| 2021-06-04 | NCT04887831 Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab | Lead sponsor | Phase 2 | Terminated Results posted | Urothelial Carcinoma; Bladder Cancer; Myelosuppression Adult; Chemotherapy-induced Neutropenia; Metastatic Bladder Cancer | 92 | 2024-03-01 |
| 2021-05-25 | NCT04902885 Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients | Collaborator Lead: Jiangsu Simcere Pharmaceutical Co., Ltd. | Phase 3 | Completed Results posted | Extensive-stage Small-cell Lung Cancer | 95 | 2022-12-31 |
| 2021-05-14 | NCT04799249 Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) | Lead sponsor | Phase 3 | Completed | TNBC - Triple-Negative Breast Cancer; Breast Cancer | 194 | 2024-05-24 |
| 2021-04-30 | NCT04863248 Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) | Lead sponsor | Phase 2 | Terminated Results posted | Metastatic Non-Small Cell Lung Cancer; NSCLC; Lung Cancer | 10 | 2022-02-02 |
| 2021-01-06 | NCT04607668 Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): | Lead sponsor | Phase 3 | Terminated Results posted | Colorectal Cancer Metastatic; Myelosuppression-Adult; Chemotherapeutic Toxicity | 326 | 2023-03-31 |
| 2020-08-15 | NCT05826756 Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting | Collaborator Lead: LUNGevity Foundation | Observational | Unknown | Lung Cancer Patients; Caregivers | 1,300 | 2025-12 |
| 2018-05-09 | NCT03455270 G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer | Lead sponsor | Phase 1 | Completed | Carcinoma, Ductal, Breast; Breast Cancer Female; Breast Neoplasm; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Stage IV Breast Cancer | 107 | 2022-09-29 |
| 2018-03-29 | NCT03455829 G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Carcinoma, Non-Small-Cell Lung; Lung Cancer; Non-small Cell Lung Cancer | 30 | 2022-02-14 |
| 2017-06-29 | NCT03041311 Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC | Lead sponsor | Phase 2 | Completed Results posted | Small Cell Lung Cancer | 107 | 2020-10-29 |
| 2017-02-02 | NCT02978716 Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) | Lead sponsor | Phase 2 | Terminated Results posted | Triple-Negative Breast Neoplasms; Breast Neoplasm; Breast Cancer; Triple-Negative Breast Cancer | 102 | 2020-02-28 |
| 2017-01 | NCT02983071 G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer | Lead sponsor | Phase 1, Phase 2 | Unknown | Carcinoma, Ductal, Breast; Breast Cancer; Breast Neoplasm | 102 | 2023-10 |
| 2016-05 | NCT02821624 First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 76 | 2017-04-04 |
| 2015-10-05 | NCT02514447 Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Small Cell Lung Cancer | 123 | 2021-10-04 |
| 2015-06-26 | NCT02499770 Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) | Lead sponsor | Phase 1, Phase 2 | Completed Results posted | Small Cell Lung Cancer | 122 | 2019-02-22 |
| 2014-09 | NCT02243150 Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1 | Lead sponsor | Phase 1 | Completed | Healthy Volunteers | 53 | 2015-12-18 |
| NCT04504513 Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer | Lead sponsor | Expanded_access | Approved for marketing | Myelosuppression Adult; Chemotherapeutic Toxicity; Small Cell Lung Cancer |