Clinical trials: CDK4/6 Inhibitor
Liposarcoma, Dedifferentiated
Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas
Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with…
- Trial name
- NCT05580588
- Testing
- SPH4336
- Where
- 9 sites in United States
- Volunteers
- 14 people
- Sponsor
- Shanghai Pharma Biotherapeutics USA Inc.
Metastatic Pancreatic Ductal Adenocarcinoma
Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD…
- Trial name
- NCT02501902
- Testing
- Palbociclib, Nab-Paclitaxel
- Where
- 26 sites in United States, Spain
- Volunteers
- 76 people
- Sponsor
- Pfizer
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
The purpose of this study is to learn about the safety and how effective the study medicine (PF-07220060) plus fulvestrant is compared to the study doctor's choice of treatment in people with advanced or metastatic breast cancer.
- Trial name
- NCT06105632
- Testing
- PF-07220060 CDK4 inhibitor, Fulvestrant, Everolimus
- Where
- 48 sites in United States, Argentina and 12 more
- Volunteers
- 333 people
- Sponsor
- Pfizer
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or…
- Trial name
- PRESERVE 2 (NCT04799249)
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 194 people
- Sponsor
- G1 Therapeutics, Inc.
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
Myelosuppression Adult, Chemotherapeutic Toxicity
Expanded Access to Trilaciclib for Patients Receiving Chemotherapy for Small Cell Lung Cancer
The purpose of this expanded access protocol is to provide access to trilaciclib for chemotherapy-induced myelosuppression in patients receiving chemotherapy as a treatment for small cell lung cancer (SCLC).
- Conditions
- Myelosuppression Adult, Chemotherapeutic Toxicity, Small Cell Lung Cancer
- Trial name
- NCT04504513
- Testing
- Trilaciclib
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American…
- Trial name
- NCT07760714
- Where
- United States
- Volunteers
- 945 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast…
- Trial name
- NCT01740427
- Testing
- PD-0332991, Letrozole
- Where
- 305 sites in United States, Australia and 16 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
Triple Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast…
- Trial name
- NCT05112536
- Testing
- Trilaciclib, Cylophosphamide, Doxorubicin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- G1 Therapeutics, Inc.
Solid Tumor, Solid Tumor, Adult
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of…
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor
- Trial name
- NCT06264921
- Testing
- NKT3447
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- NiKang Therapeutics, Inc.
Locally Advanced or Metastatic Breast Cancer
Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.
- Trial name
- NCT05860465
- Testing
- SPH4336 Tablets
- Where
- 22 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Non-small Cell Lung Cancer
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.
- Trial name
- NCT02292550
- Testing
- Ribociclib, Ceritinib
- Where
- 8 sites in United States, France and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Mantle Cell Lymphoma
Study of LY2835219 for Mantle Cell Lymphoma
The purpose of this study is to estimate the disease control rate with abemaciclib for relapsed or refractory mantle cell lymphoma.
- Trial name
- NCT01739309
- Testing
- Abemaciclib
- Where
- 7 sites in France, Germany
- Volunteers
- 28 people
- Sponsor
- Eli Lilly and Company
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic…
- Trial name
- Veronica (NCT03584009)
- Testing
- Venetoclax, Fulvestrant
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2…
- Trial name
- NCT07766018
- Testing
- Elacestrant
- Where
- 19 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Stemline Therapeutics, Inc.