Clinical trials: Palbociclib
Solid Tumor, Precision Medicine
Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion
The main purpose of this study is to explore the feasibility of selecting treatment plans based on genomic variations guided by MTB in patients with advanced refractory solid tumors.
- Trial name
- NCT06739395
- Testing
- Olaparib tablet, Temozolomide capsule, Anlotinib
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Tianjin Medical University Second Hospital
Breast Cancer, Gastrointestinal Cancer
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
This is a randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial Study. The main objective of the study is to evaluate the efficacy (meant as overall response rate ORR) of TT (targeted Therapy) vs SoC…
- Conditions
- Breast Cancer, Gastrointestinal Cancer, Non Small Cell Lung Cancer, Other Cancer
- Trial name
- ROME (NCT04591431)
- Testing
- Erlotinib, Trastuzumab, Trastuzumab emtansine
- Where
- 37 sites in Italy
- Volunteers
- 400 people
- Sponsor
- Fondazione per la Medicina Personalizzata
Breast Cancer
Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt
Cyclin-dependent kinases CDK4/6 inhibitors (CDK4/6i) combined with ET are considered the standard of care for first-line therapy of patients with hormone receptor positive, HER2 negative, advanced BC (HR+/HER2-ABC).
- Trial name
- Clinical and P (NCT07487129)
- Testing
- Palbocicilib, Ribociclib, Abemaciclib
- Where
- Egypt
- Volunteers
- 206 people
- Sponsor
- Beni-Suef University
Breast Cancer
Chidamide in Combination With Abemaciclib and Endocrinotherapy（Doctor's Choice） in Breast Cancer Patients Previously Treated With Palbociclib
To evaluate the efficacy and safety of chidamide in combination with abemaciclib and endocrinotherapy（doctor's choice） in locally advanced/metastatic HR+/HER2- breast cancer who had failed prior palbociclib therapy
- Trial name
- CINDERELLA (NCT05464173)
- Testing
- Chidamide, Abemaciclib, endocrinotherapy（doctor's choice）
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Biyun Wang, MD
Squamous Cell Carcinoma of the Head and Neck
Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug combination of palbociclib (Ibrance) plus carboplatin in patients with metastatic head and…
- Trial name
- NCT03194373
- Testing
- Palbociclib, Carboplatin
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- University of Michigan Rogel Cancer Center
Metastatic Breast Cancer
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase…
- Trial name
- NCT02738866
- Testing
- Palbociclib, Fulvestrant
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen…
- Trial name
- AMEERA-5 (NCT04478266)
- Testing
- SAR439859, Palbociclib, Letrozole
- Where
- 249 sites in United States, Argentina and 28 more
- Volunteers
- 1,068 people
- Sponsor
- Sanofi
Breast Cancer, Hormone Receptor Positive Tumor
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INGE-B (NCT02894398)
- Testing
- Palbociclib, Letrozole, Anastrozole
- Where
- 70 sites in Germany
- Volunteers
- 388 people
- Sponsor
- iOMEDICO AG
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05216432
- Testing
- RLY-2608, Fulvestrant, Palbociclib 125mg
- Where
- 37 sites in United States, Australia and 3 more
- Volunteers
- 930 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
- Trial name
- NCT00721409
- Testing
- PD 0332991, letrozole
- Where
- 104 sites in United States, Canada and 10 more
- Volunteers
- 177 people
- Sponsor
- Pfizer
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Breast Cancer, Adjuvant Therapy
Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the…
- Trial name
- SENIOR (NCT07005557)
- Testing
- Chemotherapy, CDK4/6 Inhibitor, Endocrine therapy
- Volunteers
- 1,244 people
- Sponsor
- Fudan University
Breast Cancer
PD0332991/Paclitaxel in Advanced Breast Cancer
This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer.
- Trial name
- NCT01320592
- Testing
- PD0332991, Paclitaxel
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable…
- Trial name
- NCT04858516
- Testing
- palbociclib and exemestane plus trastuzumab and pyrotinib
- Volunteers
- 57 people
- Sponsor
- Guangdong Provincial People's Hospital
Breast Neoplasm Female
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line…
- Trial name
- NCT03425838
- Testing
- CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
- Where
- 72 sites in Netherlands
- Volunteers
- 1,050 people
- Sponsor
- Borstkanker Onderzoek Groep
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metastatic Renal Cell Carcinoma, Metastatic Renal Cancer
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation…
- Conditions
- Metastatic Renal Cell Carcinoma, Metastatic Renal Cancer, Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
- Trial name
- SPARCC (NCT07123090)
- Testing
- Sasanlimab, Palbociclib, Axitinib
- Where
- 2 sites in United States
- Volunteers
- 25 people
- Sponsor
- Stephanie Berg
Metastatic Breast Cancer
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2…
- Trial name
- PARSIFAL (NCT02491983)
- Testing
- Palbociclib, Fulvestrant, Letrozole
- Where
- 48 sites in Czechia, France and 5 more
- Volunteers
- 486 people
- Sponsor
- MedSIR
Solid Tumors, NSCLC
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor…
- Conditions
- Solid Tumors, NSCLC, CRC, KRAS Gene Mutation
- Trial name
- NCT03965845
- Testing
- Telaglenestat (CB-839), Palbociclib Oral Capsule or Tablet [Ibrance]
- Where
- 10 sites in United States
- Volunteers
- 53 people
- Sponsor
- Calithera Biosciences, Inc