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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01011439
First Posted: November 11, 2009
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tiziana Life Sciences, PLC
November 10, 2009
November 11, 2009
July 18, 2017
March 2009
October 2017   (Final data collection date for primary outcome measure)
Progression-free survival rate at 3 months [ Time Frame: 3 months since treatment start ]
Same as current
Complete list of historical versions of study NCT01011439 on ClinicalTrials.gov Archive Site
  • Overall safety profile [ Time Frame: All cycles from enrollment to 28 days after last treatment ]
  • Assessment of additional measures of tumor control to further characterize the efficacy profile of PHA-848125AC [ Time Frame: Every 6 weeks during the entire study ]
  • Explorative baseline characterization of biomarkers in tumor tissue of consenting patients [ Time Frame: Baseline ]
  • Overall safety profile [ Time Frame: All cycles from enrollment to 28 days after last treatment ]
  • Assessment of additional measures of tumor control to further characterize the efficacy profile of PHA-848125AC [ Time Frame: Every 6 weeks during the entire study ]
  • Explorative baseline characterization of selected biomarkers in tumor tissue of consenting patients [ Time Frame: Baseline ]
Not Provided
Not Provided
 
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
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.
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicentre 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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Thymic Carcinoma
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.

Other Name: PHA-848125AC
Experimental: Milciclib Maleate (PHA-848125AC)
100 and 50 mg Capsule 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
Intervention: Drug: Milciclib Maleate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2019
October 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
  • Presence of measurable disease
  • Age >=18 years
  • ECOG performance status 0-1
  • Negative pregnancy test (if female in reproductive years)
  • Use of effective contraceptive methods if men and women of child producing potential
  • Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
  • Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min.
  • Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >=100,000cells/mm3 Hemoglobin >=9.0g/dL
  • Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)
  • Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1

Exclusion Criteria:

  • Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
  • Grade >1 retinopathy
  • Known brain metastases
  • Known active infections
  • Pregnant or breast feeding women
  • Diabetes mellitus uncontrolled
  • Gastrointestinal disease that would impact on drug absorption
  • Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
  • Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   United States
 
 
NCT01011439
CDKO-125a-006
2009-014338-79 ( EudraCT Number )
No
Not Provided
Not Provided
Tiziana Life Sciences, PLC
Tiziana Life Sciences, PLC
Not Provided
Study Director: Anna Petroccione, MD CLIOSS (Nerviano Medical Sciences Group), Italy
Principal Investigator: Glen Weiss, MD Scottsdale Clinical Research Institute, USA
Principal Investigator: Benjamin Besse, MD Institut Gustave Roussy, Villejuif, France
Principal Investigator: Julien Mazières, MD Hopital Larrey CHU, Toulouse, France
Principal Investigator: Silvia Novello, MD Ospedale San Luigi Gonzaga, Orbassano, Italy
Principal Investigator: Arun Rajan, MD. National Cancer Institute (NCI)
Principal Investigator: Marina C Garassino, MD Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Tiziana Life Sciences, PLC
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP