Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study
Introduction: Crotoxin has a broad antitumor activity but has shown frequent neurotoxic toxicity. To induce tolerance and limit this toxicity, we propose a new design with intra-patient dose escalation. Methods: A new Dose Limiting Toxicity definition was used. The concept of Target Ceiling Dose was...
Main Authors: | , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2017-09-01
|
Series: | Contemporary Clinical Trials Communications |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865416301053 |
id |
doaj-11519776c03a48f78a14cdffc55318b0 |
---|---|
record_format |
Article |
spelling |
doaj-11519776c03a48f78a14cdffc55318b02020-11-24T22:02:18ZengElsevierContemporary Clinical Trials Communications2451-86542017-09-017186188Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin studyJacques Medioni0Mara Brizard1Reza Elaidi2Paul F. Reid3Khadija Benlhassan4Dorothy Bray5Centre for Early-Phase Trials in Cancer (CEPEC), Hôpital Européen Georges Pompidou, Paris, France; Paris Descartes University, Paris, France; Corresponding author. Centre for Early-Phase Trials in Cancer (CEPEC), Hopital Européen Georges Pompidou, 20 rue Leblanc, 75015, Paris, France.Centre for Early-Phase Trials in Cancer (CEPEC), Hôpital Européen Georges Pompidou, Paris, France; ARTIC, Hôpital Européen Georges Pompidou, Paris, FranceARTIC, Hôpital Européen Georges Pompidou, Paris, FranceCeltic Biotech, Dublin, IrelandImmunoClin, London, United KingdomImmunoClin, London, United KingdomIntroduction: Crotoxin has a broad antitumor activity but has shown frequent neurotoxic toxicity. To induce tolerance and limit this toxicity, we propose a new design with intra-patient dose escalation. Methods: A new Dose Limiting Toxicity definition was used. The concept of Target Ceiling Dose was introduced. Results: Dose Limiting Toxicity was the inability to dose escalate twice. Target Ceiling Dose was the highest planned dose to be administered to a patient and could change for patients along time. Recommended Dose was defined similarly as in a (3 + 3) conventional design. Conclusion: This innovant design was used and the clinical trial is now closed for inclusions. Results will be presented later. Keywords: Clinical trial, Phase 1, Intra-patient dose escalation, Cancerhttp://www.sciencedirect.com/science/article/pii/S2451865416301053 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Jacques Medioni Mara Brizard Reza Elaidi Paul F. Reid Khadija Benlhassan Dorothy Bray |
spellingShingle |
Jacques Medioni Mara Brizard Reza Elaidi Paul F. Reid Khadija Benlhassan Dorothy Bray Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study Contemporary Clinical Trials Communications |
author_facet |
Jacques Medioni Mara Brizard Reza Elaidi Paul F. Reid Khadija Benlhassan Dorothy Bray |
author_sort |
Jacques Medioni |
title |
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study |
title_short |
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study |
title_full |
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study |
title_fullStr |
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study |
title_full_unstemmed |
Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study |
title_sort |
innovative design for a phase 1 trial with intra-patient dose escalation: the crotoxin study |
publisher |
Elsevier |
series |
Contemporary Clinical Trials Communications |
issn |
2451-8654 |
publishDate |
2017-09-01 |
description |
Introduction: Crotoxin has a broad antitumor activity but has shown frequent neurotoxic toxicity. To induce tolerance and limit this toxicity, we propose a new design with intra-patient dose escalation. Methods: A new Dose Limiting Toxicity definition was used. The concept of Target Ceiling Dose was introduced. Results: Dose Limiting Toxicity was the inability to dose escalate twice. Target Ceiling Dose was the highest planned dose to be administered to a patient and could change for patients along time. Recommended Dose was defined similarly as in a (3 + 3) conventional design. Conclusion: This innovant design was used and the clinical trial is now closed for inclusions. Results will be presented later. Keywords: Clinical trial, Phase 1, Intra-patient dose escalation, Cancer |
url |
http://www.sciencedirect.com/science/article/pii/S2451865416301053 |
work_keys_str_mv |
AT jacquesmedioni innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy AT marabrizard innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy AT rezaelaidi innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy AT paulfreid innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy AT khadijabenlhassan innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy AT dorothybray innovativedesignforaphase1trialwithintrapatientdoseescalationthecrotoxinstudy |
_version_ |
1725836602535575552 |