11 completed, 5 terminated, 2 unknown, 1 active not recruiting. 12 Phase 2, 7 Phase 1, 3 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 5, Terminated 4, Active not recruiting 1, Recruiting 1, Unknown 1 |
| Phase 1 | 7 | Completed 6, Unknown 1 |
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer Trilaciclib, Pembrolizumab, Gemcitabine - Metastatic Triple-Negative Breast Cancer | Phase 2 | Active not recruiting | Wake Forest University Health Sciences | 36 | 2024-01-10 | 2026-08-20 |
| Study of Trilaciclib and Lurbinectidin Trilaciclib, Lurbinectedin - Lung Cancer, Small-cell Lung Cancer | Phase 2 | Recruiting | UNC Lineberger Comprehensive Cancer Center | 30 | 2022-10-12 | 2026-09-21 |
| Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer Trilaciclib, Cylophosphamide, Doxorubicin - Triple Negative Breast Cancer, Breast Cancer | Phase 2 | Completed | G1 Therapeutics, Inc. | 24 | 2022-03-03 | 2024-03-12 |
| Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer Trilaciclib, Sacituzumab Govitecan-hziy - Triple Negative Breast Cancer | Phase 2 | Terminated | G1 Therapeutics, Inc. | 30 | 2021-12-08 | 2025-01-29 |
| 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 Trilaciclib - Extensive-stage Small-cell Lung Cancer | Phase 4 | Completed | Jiangsu Simcere Pharmaceutical Co., Ltd. | 30 | 2021-08-11 | 2023-10-06 |
| Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab Trilaciclib, Gemcitabine, Cisplatin - Urothelial Carcinoma, Bladder Cancer | Phase 2 | Terminated | G1 Therapeutics, Inc. | 92 | 2021-06-04 | 2025-09-08 |
| Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients Trilaciclib, carboplatin, etoposideļ¼or Topotecan, placebo, carboplatin, etoposideļ¼or Topotecan - Extensive-stage Small-cell Lung Cancer | Phase 3 | Completed | Jiangsu Simcere Pharmaceutical Co., Ltd. | 95 | 2021-05-25 | 2024-07-10 |
| Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) Trilaciclib, Placebo, Gemcitabine - TNBC - Triple-Negative Breast Cancer, Breast Cancer | Phase 3 | Completed | G1 Therapeutics, Inc. | 194 | 2021-05-14 | 2024-08-01 |
| Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRESERVE 4) Trilaciclib, Placebo, Docetaxel - Metastatic Non-Small Cell Lung Cancer, NSCLC | Phase 2 | Terminated | G1 Therapeutics, Inc. | 10 | 2021-04-30 | 2023-04-14 |
| Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC): Trilaciclib, Placebo - Colorectal Cancer Metastatic, Myelosuppression-Adult | Phase 3 | Terminated | G1 Therapeutics, Inc. | 326 | 2021-01-06 | 2024-11-26 |
| Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting There are no interventions in this study. All participants complete online surveys. - Lung Cancer Patients, Caregivers | Unknown | LUNGevity Foundation | 1300 | 2020-08-15 | 2023-04-28 | |
| G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer G1T48, Palbociclib - Carcinoma, Ductal, Breast, Breast Cancer Female | Phase 1 | Completed | G1 Therapeutics, Inc. | 107 | 2018-05-09 | 2026-09-21 |
| G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer G1T38, Osimertinib - Carcinoma, Non-Small-Cell Lung, Lung Cancer | Phase 1 / Phase 2 | Completed | G1 Therapeutics, Inc. | 30 | 2018-03-29 | 2023-05-06 |
| Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC Trilaciclib, Placebo, Carboplatin - Small Cell Lung Cancer | Phase 2 | Completed | G1 Therapeutics, Inc. | 107 | 2017-06-29 | 2025-09-25 |
| Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC) Trilaciclib, Gemcitabine, Carboplatin - Triple-Negative Breast Neoplasms, Breast Neoplasm | Phase 2 | Terminated | G1 Therapeutics, Inc. | 102 | 2017-02-02 | 2022-03-23 |
| G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer G1T38, Fulvestrant - Carcinoma, Ductal, Breast, Breast Cancer | Phase 1 / Phase 2 | Unknown | G1 Therapeutics, Inc. | 102 | 2017-01-01 | 2023-02-15 |
| First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers G1T38 (CDK 4/6 Inhibitor), Placebo - Healthy Volunteers | Phase 1 | Completed | G1 Therapeutics, Inc. | 76 | 2016-05-01 | 2017-06-14 |
| Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy Trilaciclib, Placebo, Topotecan - Small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | G1 Therapeutics, Inc. | 123 | 2015-10-05 | 2025-09-25 |
| Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC) Carboplatin, Placebo, Trilaciclib - Small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | G1 Therapeutics, Inc. | 122 | 2015-06-26 | 2020-08-21 |
| Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1 G1T28-1 (CDK 4/6 Inhibitor), Placebo - Healthy Volunteers | Phase 1 | Completed | G1 Therapeutics, Inc. | 53 | 2014-09-01 | 2018-12-17 |
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Small Cell Lung Carcinoma (8) · Breast Neoplasms (5) · Lung Neoplasms (5) · Triple Negative Breast Neoplasms (5) · Neoplasm Metastasis (4) · Carcinoma, Non-Small-Cell Lung (3) · Carcinoma, Ductal, Breast (2) · Carcinoma, Transitional Cell (1) · Colorectal Neoplasms (1) · Neutropenia (1) · Tobacco Use (1) · Urinary Bladder Neoplasms (1)
trilaciclib (15) · Carboplatin (9) · Gemcitabine (4) · Etoposide (2) · Glucose (2) · Water (2) · pembrolizumab (2) · Cisplatin (1) · Cyclophosphamide (1) · Docetaxel (1) · Doxorubicin (1) · Drug Therapy (1) · Fulvestrant (1) · PM 01183 (1) · Paclitaxel (1)
United States (15) · Bulgaria (5) · Georgia (5) · Spain (5) · China (4) · France (4) · Moldova (4) · Ukraine (4) · Belgium (3) · Hungary (3) · Netherlands (3) · Poland (3) · Croatia (2) · North Macedonia (2) · Serbia (2)
Antoinette Tan, MD (1) · Jared Weiss, MD (1) · Regner Tiessen, MD (1) · Renger Tiessen, MD (1) · Upal Basu Roy, PhD, MPH (1) · Ying Cheng, Doctor (1) · Yongxing Chen (1)
PMID 33595690, PMID 34405547, PMID 34408488, PMID 31504118, PMID 33004541, PMID 33123968, PMID 34777341, PMID 34873975, PMID 35842567, PMID 36135712, PMID 39113428, PMID 39579142, PMID 41810725
2016 (5), 2017 (3)