Use of Expansion Cohorts in Phase I Trials and Probability of Success in Phase II for 381 Anticancer Drugs

Purpose: Evaluate the association between the use of phase I expansion cohorts (ECs) and drug performance in phase II as well as time to approval by the FDA. Experimental Design: We performed a systematic search of MEDLINE for single-agent dose-finding adult oncology phase I trials published in 2006 to 2011 and subsequent phase II trials. Successful phase II trials were those that met their…

Read the full article here

Source: Clinical Cancer Research

Categories: Hem/Oncs

Tags: cancer

Tweets with this article

Dr Henry

Interesting read re trial designs and characteristics within #cancer DD. However, not set up to answer the Q of do expansion cohorts increase DD efficiency. Still, very valuable work. https://t.co/ZkSk7NeYjm

Using Indirect Comparisons of Prospective, Randomized Trials to Make Therapeutic Decisions in Melanoma: Cross-Trial Comparisons as Surrogates for Proper Head-To-Head Studies? | Journal of Clinical Oncology

Patients with metastatic cutaneous melanoma have several options for first-line therapy, with robust evidence-based current guidelines providing strong support for one of three general immunotherapy…

Dr Henry October 13, 2024

Michigan DO’s passion for surgery spurs four decades of annual missions

Every summer for the past 42 years, Harris M. Mainster, DO, has spent six weeks in the developing world performing surgery.

Dr Henry October 12, 2024

War and Peace

How common are armed conflict and peace between and within countries? How is this changing over time? Explore research and data on war and peace.

Dr Henry October 10, 2024

A scientific approach to entrepreneurial decision‐making: Large‐scale replication and extension

Research Summary This article runs a large-scale replication of Camuffo and colleagues in 2020, involving 759 firms in four randomized control trials. The larger sample…

Dr Henry September 27, 2024

Cancer Drug Prices in the United States: Efficacy, Innovation, Clinical Trial Evidence, and Epidemiology – PubMed

Cancer drug prices are set based on the original indication’s characteristics, thereby omitting the value of supplemental indications. Indication-specific pricing, coverage, and reimbursement policies considering…

Dr Henry September 23, 2024

Why is the market design for innovative pharmaceuticals not well understood?

A number of recent articles critical of the pharmaceutical industry have, in our view, betrayed a fundamental misunderstanding of its special ‘market design’. By this,…

Dr Henry September 11, 2024

Impact of hormone receptor status and tumor subtypes of breast cancer in young BRCA carriers

Hormone receptor expression is a known positive prognostic and predictive factor in breast cancer; however, limited evidence exists on its prognostic impact on prognosis of…

Dr Henry September 7, 2024

Real-world treatment patterns and outcomes in patients with HR+/HER2− metastatic breast cancer treated with chemotherapy in the United States

Until recently, treatment options for patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2−) metastatic breast cancer (mBC) and resistance to endocrine therapy were limited…

Dr Henry September 5, 2024

Endpoint Surrogacy in First-Line Chronic Lymphocytic Leukemia | Journal of Clinical Oncology

Purpose Surrogate endpoints are commonly used to estimate treatment efficacy in clinical studies of chronic lymphocytic leukemia (CLL). This patient- and trial-level analysis describes the…

Dr Henry September 1, 2024

High tumor mutation burden fails to predict immune checkpoint blockade response across all cancer types

High tumor mutation burden (TMB-H) has been proposed as a predictive biomarker for response to immune checkpoint blockade (ICB), largely due to the potential for…

Dr Henry August 28, 2024

Related Articles