Clinical trials: Palbociclib, completed
Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started…
- Trial name
- NCT06463626
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Novartis
Soft Tissue Sarcoma
Molecular Profiling of Advanced Soft-tissue Sarcomas
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can…
- Trial name
- MULTISARC (NCT03784014)
- Testing
- Nilotinib, Ceritinib, Capmatinib
- Where
- 17 sites in France
- Volunteers
- 603 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
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
Metastatic Breast Cancer
Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified…
- Trial name
- NCT03238196
- Testing
- Erdafitinib, Palbociclib, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell
National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
The trial consists of a series of parallel multi-centre single arm phase II trial arms, each testing an experimental targeted drug in a population stratified by multiple pre-specified actionable target putative biomarkers.
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell, Adenocarcinoma
- Trial name
- NCT02664935
- Testing
- AZD4547, Vistusertib, Palbociclib
- Where
- 25 sites in United Kingdom
- Volunteers
- 423 people
- Sponsor
- University of Birmingham
Breast Cancer
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and…
- Trial name
- NCT02684032
- Testing
- Gedatolisib, Palbociclib, Letrozole
- Where
- 41 sites in United States
- Volunteers
- 141 people
- Sponsor
- Celcuity Inc
Metastatic Breast Cancer
CARE Initiative: Real-world Emulation of the PALOMA-2 Trial
The goal of this non-interventional study is to emulate the PALOMA-2 randomized controlled trial of palbociclib as first-line therapy in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor…
- Trial name
- NCT06607601
- Testing
- Palbociclib, Letrozole
- Volunteers
- 724 people
- Sponsor
- Aetion, Inc.
Healthy
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately…
- Trial name
- NCT01756768
- Testing
- [14C]-PD-0332991
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers
A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of…
- Trial name
- NCT01821066
- Testing
- PD-0332991 alone, Tamoxifen 60 mg, Tamoxifen 20 mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
HER2-positive Breast Cancer, Breast Cancer
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer.
- Conditions
- HER2-positive Breast Cancer, Breast Cancer, Breast Cancer Stage, Recurrent Breast Cancer
- Trial name
- T-DM1 (NCT03530696)
- Testing
- Palbociclib, T-DM1
- Where
- 16 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Arizona
Advanced Solid Tumours, Breast Cancer
PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib
Part A: This is a phase Ib trial combining the CDK4/6 inhibitor palbociclib with the PI3K inhibitors taselisib, or pictilisib. There are two treatment arms during the dose escalation phase where patients will receive either…
- Trial name
- PIPA (NCT02389842)
- Testing
- Palbociclib + Taselisib / Pictilisib
- Where
- 2 sites in United Kingdom
- Volunteers
- 79 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Neoplasm Female
Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant®…
- Trial name
- SAFIA (NCT03447132)
- Testing
- Fulvestrant 500mg, Palbociclib 125mg, Goserelin 3.6 MG
- Where
- 14 sites in Algeria, Egypt and 6 more
- Volunteers
- 354 people
- Sponsor
- International Cancer Research Group, United Arab Emirates
Lymphoma, Mantle-Cell
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.
- Trial name
- NCT00420056
- Testing
- PD-0332991
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Pfizer
Healthy
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption.
- Trial name
- NCT01844323
- Testing
- Palbociclib Formulation Reference, Palbociclib Formulation Test
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Solid Neoplasm, Stage III Pancreatic Cancer
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with…
- Conditions
- Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer
- Trial name
- NCT02897375
- Testing
- Carboplatin, Cisplatin, Palbociclib
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Emory University
Breast Cancer Female, Hormone Receptor Positive Malignant Neoplasm of Breast
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone…
- Trial name
- NCT03969121
- Testing
- Palbociclib, Endocrine therapy
- Where
- 25 sites in Australia, Hong Kong and 3 more
- Volunteers
- 141 people
- Sponsor
- Kyoto Breast Cancer Research Network
Triple Negative Breast Cancer
Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer
This study is an interventional, prospective, multicentric, single-arm, open label, phase Ib clinical trial. This study will be carried out in patients diagnosed of metastatic or locally advanced unresectable triple negative…
- Trial name
- PALBOBIN (NCT04494958)
- Testing
- Combination, Palbociclib + Binimetinib
- Where
- 8 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Fundacion Oncosur
Breast Cancer
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
The objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth…
- Trial name
- NCT05452798
- Where
- Denmark
- Volunteers
- 1,054 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).
The goal of the study for patients with metastatic breast cancer (MBC) is to show that palbociclib + endocrine therapy shows a significant improvement in time-to-treatment failure over chemotherapy regimen (mono-chemotherapy with…
- Trial name
- PADMA (NCT03355157)
- Testing
- Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
- Where
- Germany
- Volunteers
- 130 people
- Sponsor
- GBG Forschungs GmbH
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.