The Experts below are selected from a list of 296505 Experts worldwide ranked by ideXlab platform
Keyvan Rezai - One of the best experts on this subject based on the ideXlab platform.
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validation of a population pharmacokinetic ppk model for onapristone ona in patients pts with cancer analysis of 2 clinical trials
Journal of Clinical Oncology, 2016Co-Authors: Keyvan Rezai, Samuel Huguet, Fanny Bret, Paul Cottu, Gerhardt Attard, Antoine Italiano, Andrea Varga, Jacques Bonneterre, Mario Campone, Anuradha JayaramAbstract:e14099Background: A type I progesterone receptor (PR) antagonist that prevents PR-induced DNA Transcription, ONA is being developed to target PR-expressing tumors. It has shown anti-cancer activity...
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safety and pharmacokinetic pk results from phase 1 of an ongoing phase 1 2 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2015Co-Authors: Antoine Italiano, Keyvan Rezai, Andrea Varga, Jacques Bonneterre, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne LesoinAbstract:e16517 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. ONA anti-cancer activity is documented in multiple pre-clinical models and clinical studies in pts wit...
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a randomized parallel dose phase 1 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2014Co-Authors: Paul Cottu, Andrea Varga, C Lhomme, Francois Lokiec, S Giacchetti, Eric Leblanc, M Espie, Anas Gazzah, V Dieras, Keyvan RezaiAbstract:TPS2643 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Presence of Transcriptionally activated PR (APR), could indicate potential for ONA anticancer activity and could be used as a predictive biomarker. Development of an IHC companion diagnostic which identifies distinct subnuclear PR distribution patterns is ongoing, and could help select patients with PR-positive cancers most likely to respond to ONA, including endometrial and breast cancers. ONA anti-cancer activity has been documented in multiple preclinical models. Prior ONA clinical studies led to objective responses in pts with hormone therapy-naive or tamoxifen-resistant breast cancer. ONA appeared well tolerated with the exception of LFT abnormalities, which would not preclude development in oncology. An extended-release (ER) tablet formulation of ONA was designed to address the LFT elevations seen with immediate-release (IR) ONA, by reducing the Cmax. Methods: This is a multi-center, open-label, randomize...
Antoine Italiano - One of the best experts on this subject based on the ideXlab platform.
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validation of a population pharmacokinetic ppk model for onapristone ona in patients pts with cancer analysis of 2 clinical trials
Journal of Clinical Oncology, 2016Co-Authors: Keyvan Rezai, Samuel Huguet, Fanny Bret, Paul Cottu, Gerhardt Attard, Antoine Italiano, Andrea Varga, Jacques Bonneterre, Mario Campone, Anuradha JayaramAbstract:e14099Background: A type I progesterone receptor (PR) antagonist that prevents PR-induced DNA Transcription, ONA is being developed to target PR-expressing tumors. It has shown anti-cancer activity...
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safety and pharmacokinetic pk results from phase 1 of an ongoing phase 1 2 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2015Co-Authors: Antoine Italiano, Keyvan Rezai, Andrea Varga, Jacques Bonneterre, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne LesoinAbstract:e16517 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. ONA anti-cancer activity is documented in multiple pre-clinical models and clinical studies in pts wit...
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onapristone ona in progesterone receptor pr expressing tumors efficacy and biomarker results of a dose escalation phase 1 study
Journal of Clinical Oncology, 2015Co-Authors: Paul Cottu, Antoine Italiano, Andrea Varga, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C LhommeAbstract:5593 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Immediate release (IR) 100 mg ONA was active in multiple preclinical models and in patients (pts) with b...
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phase 2 clinical study of onapristone ona in patients pts with uterine endometrioid adenocarcinoma ec expressing the activated progesterone receptor aprpos
Journal of Clinical Oncology, 2015Co-Authors: Jacques Bonneterre, Antoine Italiano, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C Lhomme, Dorothee ChocteauboujuAbstract:TPS5616 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Presence of Transcriptionally-activated PR (APR), seen as an aggregated subnuclear PR distribution pattern, is being explored as a predictive biomarker for ONA activity. The proposed IHC companion diagnostic could select pts with uterine EC most likely to respond to ONA. An extended-release (ER) formulation has been developed to provide constant target exposure to the anti-progestin and address previously-observed liver function test abnormalities. ONA anti-cancer activity has been documented in multiple preclinical models. Pts with APRpos EC, breast and ovarian cancers have experienced clinical benefit (PR or SD ≥ 6 months) on ONA, with excellent tolerability. The current study was designed to test the hypothesis that the APR companion diagnostic identifies the pts most likely to respond to ONA, with 80% power to detect a response rate of 30%. Methods: This is an ongoing multi-center, open-label, randomized, p...
Andrea Varga - One of the best experts on this subject based on the ideXlab platform.
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validation of a population pharmacokinetic ppk model for onapristone ona in patients pts with cancer analysis of 2 clinical trials
Journal of Clinical Oncology, 2016Co-Authors: Keyvan Rezai, Samuel Huguet, Fanny Bret, Paul Cottu, Gerhardt Attard, Antoine Italiano, Andrea Varga, Jacques Bonneterre, Mario Campone, Anuradha JayaramAbstract:e14099Background: A type I progesterone receptor (PR) antagonist that prevents PR-induced DNA Transcription, ONA is being developed to target PR-expressing tumors. It has shown anti-cancer activity...
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safety and pharmacokinetic pk results from phase 1 of an ongoing phase 1 2 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2015Co-Authors: Antoine Italiano, Keyvan Rezai, Andrea Varga, Jacques Bonneterre, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne LesoinAbstract:e16517 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. ONA anti-cancer activity is documented in multiple pre-clinical models and clinical studies in pts wit...
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onapristone ona in progesterone receptor pr expressing tumors efficacy and biomarker results of a dose escalation phase 1 study
Journal of Clinical Oncology, 2015Co-Authors: Paul Cottu, Antoine Italiano, Andrea Varga, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C LhommeAbstract:5593 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Immediate release (IR) 100 mg ONA was active in multiple preclinical models and in patients (pts) with b...
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a randomized parallel dose phase 1 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2014Co-Authors: Paul Cottu, Andrea Varga, C Lhomme, Francois Lokiec, S Giacchetti, Eric Leblanc, M Espie, Anas Gazzah, V Dieras, Keyvan RezaiAbstract:TPS2643 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Presence of Transcriptionally activated PR (APR), could indicate potential for ONA anticancer activity and could be used as a predictive biomarker. Development of an IHC companion diagnostic which identifies distinct subnuclear PR distribution patterns is ongoing, and could help select patients with PR-positive cancers most likely to respond to ONA, including endometrial and breast cancers. ONA anti-cancer activity has been documented in multiple preclinical models. Prior ONA clinical studies led to objective responses in pts with hormone therapy-naive or tamoxifen-resistant breast cancer. ONA appeared well tolerated with the exception of LFT abnormalities, which would not preclude development in oncology. An extended-release (ER) tablet formulation of ONA was designed to address the LFT elevations seen with immediate-release (IR) ONA, by reducing the Cmax. Methods: This is a multi-center, open-label, randomize...
Anne Lesoin - One of the best experts on this subject based on the ideXlab platform.
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safety and pharmacokinetic pk results from phase 1 of an ongoing phase 1 2 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2015Co-Authors: Antoine Italiano, Keyvan Rezai, Andrea Varga, Jacques Bonneterre, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne LesoinAbstract:e16517 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. ONA anti-cancer activity is documented in multiple pre-clinical models and clinical studies in pts wit...
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onapristone ona in progesterone receptor pr expressing tumors efficacy and biomarker results of a dose escalation phase 1 study
Journal of Clinical Oncology, 2015Co-Authors: Paul Cottu, Antoine Italiano, Andrea Varga, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C LhommeAbstract:5593 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Immediate release (IR) 100 mg ONA was active in multiple preclinical models and in patients (pts) with b...
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phase 2 clinical study of onapristone ona in patients pts with uterine endometrioid adenocarcinoma ec expressing the activated progesterone receptor aprpos
Journal of Clinical Oncology, 2015Co-Authors: Jacques Bonneterre, Antoine Italiano, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C Lhomme, Dorothee ChocteauboujuAbstract:TPS5616 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Presence of Transcriptionally-activated PR (APR), seen as an aggregated subnuclear PR distribution pattern, is being explored as a predictive biomarker for ONA activity. The proposed IHC companion diagnostic could select pts with uterine EC most likely to respond to ONA. An extended-release (ER) formulation has been developed to provide constant target exposure to the anti-progestin and address previously-observed liver function test abnormalities. ONA anti-cancer activity has been documented in multiple preclinical models. Pts with APRpos EC, breast and ovarian cancers have experienced clinical benefit (PR or SD ≥ 6 months) on ONA, with excellent tolerability. The current study was designed to test the hypothesis that the APR companion diagnostic identifies the pts most likely to respond to ONA, with 80% power to detect a response rate of 30%. Methods: This is an ongoing multi-center, open-label, randomized, p...
Paul Cottu - One of the best experts on this subject based on the ideXlab platform.
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validation of a population pharmacokinetic ppk model for onapristone ona in patients pts with cancer analysis of 2 clinical trials
Journal of Clinical Oncology, 2016Co-Authors: Keyvan Rezai, Samuel Huguet, Fanny Bret, Paul Cottu, Gerhardt Attard, Antoine Italiano, Andrea Varga, Jacques Bonneterre, Mario Campone, Anuradha JayaramAbstract:e14099Background: A type I progesterone receptor (PR) antagonist that prevents PR-induced DNA Transcription, ONA is being developed to target PR-expressing tumors. It has shown anti-cancer activity...
-
onapristone ona in progesterone receptor pr expressing tumors efficacy and biomarker results of a dose escalation phase 1 study
Journal of Clinical Oncology, 2015Co-Authors: Paul Cottu, Antoine Italiano, Andrea Varga, Mario Campone, Anne Floquet, Alexandra Leary, Dominique Bertonrigaud, Mariepaule Sablin, Anne Lesoin, C LhommeAbstract:5593 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Immediate release (IR) 100 mg ONA was active in multiple preclinical models and in patients (pts) with b...
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a randomized parallel dose phase 1 study of onapristone ona in patients pts with progesterone receptor pr expressing cancers
Journal of Clinical Oncology, 2014Co-Authors: Paul Cottu, Andrea Varga, C Lhomme, Francois Lokiec, S Giacchetti, Eric Leblanc, M Espie, Anas Gazzah, V Dieras, Keyvan RezaiAbstract:TPS2643 Background: ONA is a type I PR antagonist, which prevents PR-induced DNA Transcription. Presence of Transcriptionally activated PR (APR), could indicate potential for ONA anticancer activity and could be used as a predictive biomarker. Development of an IHC companion diagnostic which identifies distinct subnuclear PR distribution patterns is ongoing, and could help select patients with PR-positive cancers most likely to respond to ONA, including endometrial and breast cancers. ONA anti-cancer activity has been documented in multiple preclinical models. Prior ONA clinical studies led to objective responses in pts with hormone therapy-naive or tamoxifen-resistant breast cancer. ONA appeared well tolerated with the exception of LFT abnormalities, which would not preclude development in oncology. An extended-release (ER) tablet formulation of ONA was designed to address the LFT elevations seen with immediate-release (IR) ONA, by reducing the Cmax. Methods: This is a multi-center, open-label, randomize...