MedPath

Clinical Trial News

Palbociclib Plus Letrozole Significantly Extends Progression-Free Survival in ER+ Breast Cancer

• Palbociclib, a CDK4/6 inhibitor, combined with letrozole, an aromatase inhibitor, significantly improved progression-free survival (PFS) in postmenopausal women with ER+/HER2- metastatic breast cancer. • The PALOMA-1/TRIO-18 phase II trial demonstrated a median PFS of 20.2 months with the palbociclib-letrozole combination, compared to 10.2 months with letrozole alone. • Palbociclib received accelerated FDA approval based on these results, pending confirmatory phase III trial outcomes, marking a significant advancement in targeted therapy for hormone receptor-positive breast cancer. • Common adverse events associated with the combination therapy included neutropenia and leukopenia, manageable through dose modification and blood count monitoring.

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

NCT02297438Active, Not RecruitingPhase 3
Pfizer
Posted 3/23/2015

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)

NCT01976169CompletedPhase 1
University of Texas Southwestern Medical Center
Posted 1/24/2014

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

NCT02389842Unknown StatusPhase 1
Royal Marsden NHS Foundation Trust
Posted 3/25/2015

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

NCT02384239CompletedPhase 2
University of California, San Francisco
Posted 10/19/2015

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

NCT02296801CompletedPhase 2
NSABP Foundation Inc
Posted 1/1/2015

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

NCT02028507CompletedPhase 3
Spanish Breast Cancer Research Group
Posted 3/13/2014

A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

NCT01684215CompletedPhase 2
Pfizer
Posted 10/19/2012

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

NCT02308020CompletedPhase 2
Eli Lilly and Company
Posted 4/20/2015

PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

NCT01723774Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 4/10/2013

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

NCT01864746CompletedPhase 3
German Breast Group
Posted 10/30/2013

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

NCT02040857CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2014

Pancreatic Cancer Action Network and Perthera Launch "Know Your Tumor" Initiative for Precision Treatment

  • The Pancreatic Cancer Action Network has partnered with Perthera to launch "Know Your Tumor" initiative, offering molecular profiling services to guide personalized treatment decisions for pancreatic cancer patients.
  • The program aims to streamline molecular testing processes, providing comprehensive tumor analysis reports within one month of biopsy, while building a database of approximately 3000 patient molecular profiles over three years.
  • With pancreatic cancer's dire 6% five-year survival rate, this initiative represents a significant step toward the goal of doubling survival rates by 2020 through personalized treatment approaches.

Serum Free Light Chain Levels Predict Need for Future PCI in STEMI Patients

  • Combined free immunoglobulin light chain (cFLC) levels were evaluated in ST-elevation myocardial infarction (STEMI) patients, showing a peak on day 7 post-MI.
  • cFLC levels in STEMI patients correlated with cystatin C and negatively correlated with CD14++CD16- monocytes, indicating associations with renal function and inflammation.
  • Elevated cFLC concentrations were associated with an increased need for future percutaneous coronary intervention (PCI), suggesting a predictive value.
  • The study highlights the potential of cFLC levels as a biomarker for risk stratification in STEMI patients regarding future interventional needs.

Novartis Revolutionizes Clinical Trial Recruitment Through Digital Innovation and Social Media

  • Novartis has launched a dedicated Twitter channel @NovartisCancrUS reaching nearly 10,000 followers to promote cancer clinical trials and facilitate patient recruitment in the United States.
  • The company has developed an interactive global clinical trials database with GPS functionality, allowing patients worldwide to locate and connect with nearby trial opportunities.
  • Novartis's innovative Signature trial program enables personalized cancer trials across the US, matching patients' genetic alterations to relevant drugs while allowing them to receive treatment closer to home.

Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer

NCT02069093CompletedPhase 2
Novartis Pharmaceuticals
Posted 5/1/2014

PARP Inhibitors Show Promise in Epithelial Ovarian and Breast Cancers with BRCA1/2 Mutations

  • PARP inhibitors have demonstrated efficacy in platinum-sensitive epithelial ovarian cancer, particularly in high-grade serous disease, and in breast cancer with BRCA1/2 mutations.
  • Olaparib maintenance therapy significantly improved progression-free survival in relapsed high-grade serous ovarian cancer, especially in patients with BRCA1/2 mutations.
  • Clinical trials are underway to evaluate PARP inhibitors like veliparib, rucaparib, and niraparib in various solid tumors, aiming to identify predictive biomarkers for patient selection.
  • Research suggests PARP inhibitors' mechanism involves multiple aspects of PARP1 biology, including BER inhibition, PARP1 trapping, defective BRCA1 recruitment, and NHEJ activation.

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer

NCT02032823Active, Not RecruitingPhase 3
AstraZeneca
Posted 4/22/2014

Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

NCT01924533CompletedPhase 3
AstraZeneca
Posted 9/3/2013

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer

NCT01847274CompletedPhase 3
Tesaro, Inc.
Posted 6/21/2013

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

NCT02106546CompletedPhase 3
AbbVie
Posted 4/10/2014

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

NCT01968213CompletedPhase 3
pharmaand GmbH
Posted 4/7/2014

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

NCT02184195CompletedPhase 3
AstraZeneca
Posted 12/16/2014

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

NCT02000622Active, Not RecruitingPhase 3
AstraZeneca
Posted 3/27/2014

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

NCT01844986Active, Not RecruitingPhase 3
AstraZeneca
Posted 8/26/2013

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

NCT01905592TerminatedPhase 3
Tesaro, Inc.
Posted 2/25/2014

A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer

NCT02163694CompletedPhase 3
AbbVie
Posted 4/8/2014

A Study Evaluating Safety and Efficacy of the Addition of ABT-888 Plus Carboplatin Versus the Addition of Carboplatin to Standard Chemotherapy Versus Standard Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer

NCT02032277CompletedPhase 3
AbbVie
Posted 4/2/2014

Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

NCT02152982Active, Not RecruitingPhase 2
National Cancer Institute (NCI)
Posted 12/15/2014

Tyra Biosciences Advances FGFR Inhibitor Pipeline with Multiple Clinical Trials

  • Tyra Biosciences is developing TYRA-300, a selective FGFR3 inhibitor, for bladder cancer and skeletal dysplasia, with Phase 2 trials for achondroplasia expected to begin in Q1 2025.
  • SURF201, a Phase 1 clinical study, is evaluating TYRA-200, an oral FGFR1/2/3 inhibitor, in patients with advanced cholangiocarcinoma and other solid tumors harboring FGFR2 alterations.
  • The FDA has cleared Tyra Biosciences' IND for TYRA-430, a FGFR4/3-biased inhibitor, allowing a Phase 1 study in advanced hepatocellular carcinoma and other solid tumors with FGF/FGFR pathway aberrations.

Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations

NCT06160752RecruitingPhase 1
Tyra Biosciences, Inc
Posted 11/22/2023

NIH-Sponsored Trials Validate Severity of Persistent Lyme Disease Symptoms

  • Four NIH-sponsored, double-blind, randomized, placebo-controlled trials validate the severity of Persistent Lyme Disease Symptoms (PLDS).
  • PLDS result in a quality of life comparable to other serious chronic illnesses, impacting fatigue, pain, role function, psychopathology, and cognition.
  • The trials refute claims that PLDS are merely "aches and pains of daily living" or symptoms unrelated to Lyme disease.
  • Findings suggest physicians should address PLDS with the same vigor as other chronic illnesses, focusing on cure or symptom amelioration.

Real-World Evidence Shows Positive Impact on HTA Drug Approvals, Analysis Reveals

• Analysis of 1,840 Health Technology Assessment decisions reveals that submissions including real-world evidence achieved 77% approval rate compared to 67% without RWE.
• Case studies from Australia, Scotland, and France demonstrate how real-world evidence helped secure positive reimbursement decisions for drugs like Yervoy, Zaltrap, and Myozyme.
• Despite proven benefits, real-world evidence was only utilized in 6% of HTA evaluations, suggesting significant untapped potential for both pharmaceutical companies and assessment agencies.

Beyond the Pill: Pharmaceutical Industry Shifts Focus to Holistic Patient Solutions

  • Healthcare systems' financial constraints and rising patient expectations are forcing pharmaceutical companies to expand beyond traditional drug development to provide comprehensive healthcare solutions.
  • Innovation in pharmaceutical industry now encompasses smart packaging, diagnostic tools, and digital health solutions to improve medication adherence and patient outcomes.
  • Companies must redefine 'unmet needs' to include broader healthcare challenges, focusing on value demonstration and improved patient outcomes rather than just pharmacological interventions.

Navigating the $35 Billion Biosimilar Market: New Marketing Paradigms for Success

  • The biosimilar market is projected to reach $35 billion by 2020, presenting significant opportunities within the $169 billion biologics sector for companies that can effectively differentiate their products.
  • Marketing biosimilars presents a unique challenge: manufacturers must first establish similarity to gain physician trust, then differentiate their products through innovative delivery systems and value-added services.
  • With over 700 biosimilars currently in development, success requires extensive market education, strategic differentiation, and substantial investment in patient-centric solutions beyond competitive parity.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.