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

Sponsor:	Nerviano Medical Sciences
Information provided by (Responsible Party):	Nerviano Medical Sciences
ClinicalTrials.gov Identifier:	NCT01011439

Purpose

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.

Condition	Intervention	Phase
Thymic Carcinoma	Drug: PHA-848125AC	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:

Progression-free survival rate at 3 months [ Time Frame: 3 months since treatment start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall safety profile [ Time Frame: All cycles from enrollment to 28 days after last treatment ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Explorative baseline characterization of biomarkers in tumor tissue of consenting patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011439

Contacts

Contact: Joyce Schaffer, RN

877 273 3713

clinicaltrials@shc.org

Locations

United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare	Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN 877-273-3713 clinicaltrials@shc.org
Principal Investigator: Glen Weiss, MD
United States, Maryland
NIH, Center for Cancer Research, Medical Oncology	Recruiting
Bethesda, Maryland, United States, 20892
Contact: Arlene Berman, RN, MS, OCN 301-435-5609 arleneb@mail.nih.gov
Principal Investigator: Giuseppe Giaccone, MD. Ph.D
France
Hopital Larrey	Recruiting
Toulouse Cedex, France, 31059
Contact: Julien Mazières, MD +33 05 67 77 18 37 mazieres.j@chu-toulouse.fr
Principal Investigator: Julien Mazières, MD
Institut de cancerologie Gustave Roussy	Recruiting
Villejuif Cedex, France, 94805
Contact: Benjamin Besse, MD PhD +33 142114322 besse@igr.fr
Principal Investigator: Benjamin Besse, MD PhD
Italy
Azienda Ospedaliera San Luigi Gonzaga	Recruiting
Orbassano, Italy, 10043
Contact: Silvia Novello, MD +39 011 9026978 silvia.novello@unito.it
Principal Investigator: Silvia Novello, MD

Sponsors and Collaborators

Nerviano Medical Sciences

Investigators

Study Director:	Angela Scaburri, BiolSci D	Nerviano Medical Sciences, 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:	Giuseppe Giaccone, MD. Ph.D	National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party:	Nerviano Medical Sciences
ClinicalTrials.gov Identifier:	NCT01011439 History of Changes
Other Study ID Numbers:	CDKO-125a-006, EudraCT Number 2009-014338-79
Study First Received:	November 10, 2009
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency

Keywords provided by Nerviano Medical Sciences:

B3 and C malignant thymoma

Additional relevant MeSH terms:

Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012