Improving Dose-Optimization Processes Used in Oncology Drug Development to Minimize Toxicity and Maximize Benefit to Patients

FIGHT-101, a first-in-human study of potent and selective FGFR 1–3 inhibitor pemigatinib in pan-cancer patients with FGF/FGFR alterations and advanced malignancies

(2022) V. Subbiah et al.   ANNALS OF ONCOLOGY

FDA Approval Summary: Revised Indication and Dosing Regimen for Ponatinib Based on the Results of the OPTIC Trial

(2022) E Dianne Pulte et al.   ONCOLOGIST

Call to Action for Improving Oral Anticancer Agent Adherence

(2022) Laura A. Levit et al.   JOURNAL OF CLINICAL ONCOLOGY

Randomised Phase 1 clinical trials in oncology

(2021) Alexia Iasonos et al.   BRITISH JOURNAL OF CANCER

Moving Beyond 3+3: The Future of Clinical Trial Design

(2021) Razelle Kurzrock et al.   American Society of Clinical Oncology educational book / ASCO. American Society of Clinical Oncology. Meeting

The Drug-Dosing Conundrum in Oncology — When Less Is More

(2021) Mirat Shah et al.   NEW ENGLAND JOURNAL OF MEDICINE

Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study

(2020) Ghassan K Abou-Alfa et al.   LANCET ONCOLOGY

Efficacy of Selpercatinib in RET Fusion–Positive Non–Small-Cell Lung Cancer

(2020) Alexander Drilon et al.   NEW ENGLAND JOURNAL OF MEDICINE

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma

(2019) Yohann Loriot et al.   NEW ENGLAND JOURNAL OF MEDICINE

An Integrative Approach to Inform Optimal Administration of OX40 Agonist Antibodies in Patients with Advanced Solid Tumors

(2019) Rui Wang et al.   CLINICAL CANCER RESEARCH

Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study

(2019) Sagar Lonial et al.   LANCET ONCOLOGY

FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33‐Positive Acute Myeloid Leukemia

(2018) Kelly J. Norsworthy et al.   ONCOLOGIST

Dose Finding of Small-Molecule Oncology Drugs: Optimization throughout the Development Life Cycle

(2016) P. A. Ja nne et al.   CLINICAL CANCER RESEARCH

Lessons Learned: Dose Selection of Small Molecule-Targeted Oncology Drugs

(2016) J. M. Bullock et al.   CLINICAL CANCER RESEARCH

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

(2016) L. Nie et al.   CLINICAL CANCER RESEARCH

Nonclinical Evaluations of Small-Molecule Oncology Drugs: Integration into Clinical Dose Optimization and Toxicity Management

(2016) D. M. Dambach et al.   CLINICAL CANCER RESEARCH

Seamless Oncology-Drug Development

(2016) Tatiana M. Prowell et al.   NEW ENGLAND JOURNAL OF MEDICINE

Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example

(2015) J. R. Sachs et al.   CLINICAL CANCER RESEARCH

First-In-Human Phase I Study of Lurbinectedin (PM01183) in Patients with Advanced Solid Tumors

(2014) M. E. Elez et al.   CLINICAL CANCER RESEARCH

Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

(2014) Leonard V. Sacks et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial

(2014) Caroline Robert et al.   LANCET

Redefining the primary objective of phase I oncology trials

(2014) Mark J. Ratain   Nature Reviews Clinical Oncology

Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter?

(2009) S Postel-Vinay et al.   BRITISH JOURNAL OF CANCER

Maximum tolerated dose: clinical endpoint for a bygone era?

(2009) Chris H. Takimoto   Targeted Oncology

A History of Cancer Chemotherapy

(2008) Vincent T. DeVita et al.   CANCER RESEARCH

Optimising the design of phase II oncology trials: The importance of randomisation

(2008) Mark J. Ratain et al.   EUROPEAN JOURNAL OF CANCER

Challenges and Pitfalls of Combining Targeted Agents in Phase I Studies

(2008) Stephen A. Cannistra   JOURNAL OF CLINICAL ONCOLOGY