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Clinical Trial News

India Revamps Clinical Trial Regulations to Align with Global Standards

  • India has significantly reformed its clinical trial regulations, extending SAE reporting timelines from 10 to 14 days to match international standards and streamlining the approval process.
  • The regulatory framework now requires trials to be evaluated based on risk-benefit assessment, innovation value, and unmet medical needs in the country, ensuring greater transparency.
  • New draft standards for accreditation of sites, investigators, and ethics committees have been introduced by CDSCO, aiming to enhance operational standards across clinical research.

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 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

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

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

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

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 (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

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 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

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

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

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

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

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.

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

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

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

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

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

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

NCT02184195CompletedPhase 3
AstraZeneca
Posted 12/16/2014

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

NCT01924533CompletedPhase 3
AstraZeneca
Posted 9/3/2013

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

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

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

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

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

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.

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.
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