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Spots Global Cancer Trial Database for Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma

Official Title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

Study ID: NCT01011439

Interventions

Milciclib Maleate

Study Description

Brief Summary: The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.

Detailed Description: The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

TGen Clinical Research Services at Scottsdale Healthcare, Scottsdale, Arizona, United States

NIH, Center for Cancer Research, Medical Oncology, Bethesda, Maryland, United States

Hopital Larrey, Toulouse Cedex, , France

Institut de cancerologie Gustave Roussy, Villejuif Cedex, , France

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milano, (mi), Italy

Azienda Ospedaliera San Luigi Gonzaga, Orbassano, , Italy

Contact Details

Name: Glen Weiss, MD

Affiliation: Scottsdale Clinical Research Institute, USA

Role: PRINCIPAL_INVESTIGATOR

Name: Benjamin Besse, MD

Affiliation: Institut Gustave Roussy, Villejuif, France

Role: PRINCIPAL_INVESTIGATOR

Name: Julien Mazières, MD

Affiliation: Hopital Larrey CHU, Toulouse, France

Role: PRINCIPAL_INVESTIGATOR

Name: Silvia Novello, MD

Affiliation: Ospedale San Luigi Gonzaga, Orbassano, Italy

Role: PRINCIPAL_INVESTIGATOR

Name: Arun Rajan, MD.

Affiliation: National Cancer Institute (NCI)

Role: PRINCIPAL_INVESTIGATOR

Name: Marina C Garassino, MD

Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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