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

NCT01011439 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-02-06

Study results available
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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.

Conditions

  • Thymic Carcinoma

Interventions

DRUG

Milciclib Maleate

150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle. Number of cycles: until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Tiziana Life Sciences LTD

    lead INDUSTRY

Principal Investigators

  • Glen Weiss, MD · Scottsdale Clinical Research Institute, USA

  • Benjamin Besse, MD · Institut Gustave Roussy, Villejuif, France

  • Julien Mazières, MD · Hopital Larrey CHU, Toulouse, France

  • Silvia Novello, MD · Ospedale San Luigi Gonzaga, Orbassano, Italy

  • Arun Rajan, MD. · National Cancer Institute (NCI)

  • Marina C Garassino, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-22
Primary Completion
2017-05-31
Completion
2018-12-17

Countries

  • United States
  • France
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011439 on ClinicalTrials.gov