More may not be better: reconsidering early clinical trial design in the era of targeted cancer therapeutics

Review Oncology

Oncology phase I trial design and conduct: time for a change- MDICT Guidelines 2022

D. Araujo et al.

Summary: In 2021, the FDA Oncology Center of Excellence launched Project Optimus to optimize dosage for oncology drugs. The MDICT Taskforce reviewed and discussed dosage optimization for oncology trials, providing recommendations for trial design and a practical guide for phase I trials. The aim is to improve dosage selection in early clinical trials of new anticancer treatments and ultimately enhance patient outcomes.

ANNALS OF ONCOLOGY (2023)

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Article Biochemistry & Molecular Biology

Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma

E. A. Rozeman et al.

Summary: The combination of neoadjuvant ipilimumab plus nivolumab showed high pathologic response rates (pRRs) in patients with macroscopic stage III melanoma. High tumor mutational burden (TMB) and high interferon-gamma-related gene expression signature score (IFN-gamma score) were associated with pathologic response and a low risk of relapse. These findings support the potential predictive value of TMB and IFN-gamma score in the treatment of melanoma patients.

NATURE MEDICINE (2021)

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Article Medicine, General & Internal

KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors

David S. Hong et al.

NEW ENGLAND JOURNAL OF MEDICINE (2020)

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Article Medicine, General & Internal

6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Helena M. Earl et al.

LANCET (2019)

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Article Oncology

Rendering the 3+3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Lei Nie et al.

CLINICAL CANCER RESEARCH (2016)

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Editorial Material Oncology

TARGETED THERAPIES Redefining the primary objective of phase I oncology trials

Mark J. Ratain

NATURE REVIEWS CLINICAL ONCOLOGY (2014)

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Article Oncology

Endpoints and other considerations in phase I studies of targeted anticancer therapy: Recommendations from the task force on methodology for the development of innovative Cancer Therapies (MDICT)

Christopher M. Booth et al.

EUROPEAN JOURNAL OF CANCER (2008)

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More may not be better: reconsidering early clinical trial design in the era of targeted cancer therapeutics

Related references

Oncology phase I trial design and conduct: time for a change- MDICT Guidelines 2022

Survival and biomarker analyses from the OpACIN-neo and OpACIN neoadjuvant immunotherapy trials in stage III melanoma

KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors

6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Rendering the 3+3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

TARGETED THERAPIES Redefining the primary objective of phase I oncology trials

Endpoints and other considerations in phase I studies of targeted anticancer therapy: Recommendations from the task force on methodology for the development of innovative Cancer Therapies (MDICT)

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