MedPath

Clinical Trial News

Phase 1b Trial of Dostarlimab Combinations Shows Promise in Advanced Solid Tumors

A phase 1b clinical trial, IOLite, evaluated the safety and efficacy of dostarlimab in combination with niraparib or carboplatin–paclitaxel, with or without bevacizumab, in patients with advanced solid tumors. The study found these combinations to be safe and tolerable, with promising antitumor activity. The trial established recommended phase 2 doses for each combination and observed no new safety signals. Tumor response rates were encouraging, particularly in combinations involving bevacizumab, suggesting potential for further investigation in larger, randomized phase 3 studies.

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer

NCT02657889CompletedPhase 1
Tesaro, Inc.
Posted 4/15/2016

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042

NCT03307785Active, Not RecruitingPhase 1
Tesaro, Inc.
Posted 10/12/2017

Study Evaluates Intra-arterial Tenecteplase Following Endovascular Therapy for Acute Stroke

A new clinical trial, ATTENTION-IA, is investigating the efficacy and safety of intra-arterial tenecteplase after successful endovascular therapy (EVT) in patients with acute posterior circulation large or medium vessel occlusion. The trial aims to improve outcomes for stroke patients by addressing persistent distal hypoperfusion and microcirculatory obstruction, common issues even after successful EVT.

Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

NCT05684172CompletedPhase 2
The First Affiliated Hospital of University of Science and Technology of China
Posted 1/24/2023

FDA Approves Three Novel Therapies for Relapsed Multiple Myeloma

  • The FDA approved daratumumab (Darzalex) as a monotherapy for multiple myeloma patients who have undergone at least three prior treatments.
  • Ixazomib (Ninlaro), a proteasome inhibitor, was approved for relapsed multiple myeloma patients after one prior treatment, showing improved progression-free survival.
  • Elotuzumab (Empliciti) received approval for patients with one to three prior therapies, demonstrating extended progression-free survival when combined with lenalidomide and dexamethasone.

The Reporting of Adverse Events in Oncology Phase III Trials

A study comparing the current status of adverse events (AEs) reporting in oncology phase III trials with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership reveals significant discrepancies. While most reports include grade 3/4 AEs, there's a lack of comprehensive reporting on grade 5 AEs, AEs leading to study withdrawal, and dose reduction, contrary to EORTC members' expectations.

FDA Approves Record 45 New Drugs in 2015, Led by Breakthrough Cancer Immunotherapy Opdivo

• The FDA approved 45 new drugs in 2015, marking a significant rise in R&D productivity, with Bristol-Myers Squibb's immunotherapy Opdivo leading the pack with five new indications for various cancers.
• Novel treatments like Vertex's Orkambi for cystic fibrosis and Novartis's Entresto for heart failure demonstrated remarkable clinical innovation, though pricing concerns remained central to industry discussions.
• The year saw major developments in drug pricing debates, with the emergence of ICER as an independent US cost-effectiveness watchdog and increased scrutiny of pharmaceutical pricing practices.

Sanofi and Boehringer Ingelheim Announce €11.4B Asset Swap Deal to Reshape Consumer Health Market

  • Sanofi will acquire Boehringer Ingelheim's consumer health division valued at €6.7B, while divesting its animal health business Merial for €11.4B, positioning Sanofi as the global leader in consumer healthcare.
  • The strategic exchange includes a €4.7B cash payment to Sanofi from Boehringer Ingelheim, with the combined deal expected to create a consumer health business generating approximately €5.1B in annual revenue.
  • The asset swap, set to close in Q4 2016, maintains workforce stability with minimal redundancies planned, requiring regulatory approval and union consultation before completion.

Novel Cancer Drug Development Pipeline Shows Promise Across Multiple Therapeutic Areas

  • Recent advances in oncology drug development have shown significant progress across multiple cancer types, with several promising candidates entering late-stage clinical trials.
  • Pharmaceutical companies are increasingly focusing on targeted therapies and precision medicine approaches, leading to more personalized treatment options for cancer patients.
  • New drug development strategies are addressing previously challenging cancer targets, with improved efficacy and safety profiles compared to conventional treatments.

The BWEL Trial: A Study on Weight Loss and Breast Cancer Recurrence

The Breast Cancer Weight Loss (BWEL) trial investigates the impact of weight loss on reducing cancer recurrence in overweight or obese women with stage II-III breast cancer. This randomized, controlled trial compares a telephone-based weight loss intervention plus health education materials against health education materials alone, aiming for a ≥10% weight loss through increased physical activity and caloric restriction.

Breast Cancer WEight Loss Study (BWEL Study)

NCT02750826Active, Not RecruitingPhase 3
Alliance for Clinical Trials in Oncology
Posted 9/16/2016

Palbociclib Plus Letrozole Approved for First-Line ER+, HER2- Metastatic Breast Cancer

• Palbociclib, a CDK4/6 inhibitor, received FDA accelerated approval in combination with letrozole for postmenopausal women with ER+, HER2- metastatic breast cancer. • The approval was based on the PALOMA-1 trial, which demonstrated improved progression-free survival compared to letrozole alone in previously untreated patients. • Common adverse events associated with the combination therapy include neutropenia, leukopenia, and fatigue, requiring careful monitoring and dose adjustments. • Clinicians should consider toxicities, quality-of-life issues, and cost when making treatment decisions, as alternative regimens with different toxicity profiles exist.

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

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

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.

NCT00555906CompletedPhase 2
Pfizer
Posted 1/1/2008

Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer

NCT00721409CompletedPhase 2
Pfizer
Posted 9/15/2008

PD 0332991 and Cetuximab in Patients With Incurable SCCHN

NCT02101034CompletedPhase 1
Washington University School of Medicine
Posted 6/17/2014

A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

NCT01227434TerminatedPhase 2
University of California, San Francisco
Posted 9/1/2010

FDA Approves Trofinetide for Rett Syndrome Treatment

The US Food and Drug Administration (FDA) has approved trofinetide, a synthetic analog of glycine-proline-glutamate (GPE), for the treatment of Rett syndrome (RTT) in adults and pediatric patients aged 2 years and older. This approval marks a significant milestone in the treatment of RTT, a rare neurodevelopmental disorder, following years of scientific and clinical research.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.