# Dose finding designs for late-onset toxicities

> **NIH NIH R01** · UNIVERSITY OF VIRGINIA · 2021 · $339,060

## Abstract

Project Summary / Abstract:
The current landscape of oncology drug development is posing a challenge to widely-accepted
methods used in dose-finding clinical trials. One of the biggest challenges in these trials is
identifying an appropriate recommended Phase II dose (RP2D) when relevant toxicity events
occur in later cycles of therapy. Accepted dose finding methods were intended for use in trials in
which toxicity is observed early on in the treatment course, and they may not be appropriate for
designing studies with the potential for pertinent toxicities beyond early cycles of therapy.
Consequently, many novel therapies are registered by the FDA at doses different than those
identified in Phase I. There is a growing need for new study designs that address the clinical
realities and statistical considerations arising by these new treatment paradigms. Thus, the goal
of this proposal is to develop novel dose-finding methods that account for late-onset toxicities in
guiding dose allocation and to more accurately define the overall tolerance of the treatment.

## Key facts

- **NIH application ID:** 10207019
- **Project number:** 1R01CA247932-01A1
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Nolan Wages
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $339,060
- **Award type:** 1
- **Project period:** 2021-03-01 → 2024-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10207019

## Citation

> US National Institutes of Health, RePORTER application 10207019, Dose finding designs for late-onset toxicities (1R01CA247932-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10207019. Licensed CC0.

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