ReviewClinical cancer research : an official journal of the American Association for Cancer Research2014
Design of phase I combination trials: recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.
Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05145296 (Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Targeting Peripheral And Central Humoral Alloimmune Memory With Daratumumab And With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation), which is not on this map. Cited by 36 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Non-Randomized, Single-Center Pilot Trial Assessing The Safety/Efficacy Of Targeting Peripheral And Central Humoral Alloimmune Memory With Daratumumab And With Belatacept In Highly HLA-Sensitized Patients Awaiting Kidney Transplantation
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Olaparib monotherapy or combination therapy in lung cancer: an updated systematic review and meta- analysis.Frontiers in oncology · 2025Pooled it
- Systematic review of phase-I/II trials enrolling refractory and recurrent Ewing sarcoma: Actual knowledge and future directions to optimize the research.Cancer medicine · 2021Pooled it
- Quality and Reporting Accuracy of Phase 1 Drug Radiation Clinical Trials.JAMA oncology · 2016Pooled it
- Serum C-Telopeptide Collagen Crosslinks and Plasma Soluble VEGFR2 as Pharmacodynamic Biomarkers in a Trial of Sequentially Administered Sunitinib and Cilengitide.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015Trial
- Considerations on combination therapies for disease modification in Parkinson's.NPJ Parkinson's disease · 2026Article
- Additivity, Not Synergy, Underlies the Efficacy of Current Combination Regimens in Urothelial Cancer.Cancer research communications · 2026Article
- Peripheral nervous system safety signals of antibody-drug conjugates: cross-database reproducibility and labeling gaps identified using FAERS, JADER, and CVARD.Frontiers in pharmacology · 2026Article
- Analysis of Phase I Clinical Trial Design of Anti-Cancer Agents.Therapeutic innovation & regulatory science · 2025Article
- Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Article
- Additivity predicts the efficacy of most approved combination therapies for advanced cancer.Nature cancer · 2023Article
- Review
- Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.BMC medicine · 2023Review
- Early drug development in solid tumours: analysis of National Cancer Institute-sponsored phase 1 trials.Lancet (London, England) · 2022Article
- Pharmacology-based ranking of anti-cancer drugs to guide clinical development of cancer immunotherapy combinations.Journal of experimental & clinical cancer research : CR · 2021Review
- Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer.Cancer chemotherapy and pharmacology · 2021Article
- Comparison of Various Phase I Combination Therapy Designs in Oncology for Evaluation of Early Tumor Shrinkage Using Simulations.CPT: pharmacometrics & systems pharmacology · 2020Article
- Nanopharmaceutics: Part II-Production Scales and Clinically Compliant Production Methods.Nanomaterials (Basel, Switzerland) · 2020Review
- Review
- How to schedule VEGF and PD-1 inhibitors in combination cancer therapy?BMC systems biology · 2019Article
- Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.Journal of the National Cancer Institute · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
Anticancer drugs are combined in an effort to treat a heterogeneous tumor or to maximize the pharmacodynamic effect. The development of combination regimens, while desirable, poses unique challenges. These include the selection of agents for combination therapy that may lead to improved efficacy while maintaining acceptable toxicity, the design of clinical trials that provide informative results for individual agents and combinations, and logistic and regulatory challenges. The phase I trial is often the initial step in the clinical evaluation of a combination regimen. In view of the importance of combination regimens and the challenges associated with developing them, the Clinical Trial Design (CTD) Task Force of the National Cancer Institute Investigational Drug Steering Committee developed a set of recommendations for the phase I development of a combination regimen. The first two recommendations focus on the scientific rationale and development plans for the combination regimen; subsequent recommendations encompass clinical design aspects. The CTD Task Force recommends that selection of the proposed regimens be based on a biologic or pharmacologic rationale supported by clinical and/or robust and validated preclinical evidence, and accompanied by a plan for subsequent development of the combination. The design of the phase I clinical trial should take into consideration the potential pharmacokinetic and pharmacodynamic interactions as well as overlapping toxicity. Depending on the specific hypothesized interaction, the primary endpoint may be dose optimization, pharmacokinetics, and/or pharmacodynamics (i.e., biomarker).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.