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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Thymic Carcinoma	Drug: Milciclib Maleate	Phase 2

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
Study Start Date :	March 2009
Estimated Primary Completion Date :	October 2017
Estimated Study Completion Date :	June 2019

Arms and Interventions

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Arm	Intervention/treatment
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	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

Outcome Measures

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Primary Outcome Measures :

1. Progression-free survival rate at 3 months [ Time Frame: 3 months since treatment start ]

Secondary Outcome Measures :

1. Overall safety profile [ Time Frame: All cycles from enrollment to 28 days after last treatment ]
2. 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 ]
3. Explorative baseline characterization of biomarkers in tumor tissue of consenting patients [ Time Frame: Baseline ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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 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

Contacts and Locations

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Locations

United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, Maryland
NIH, Center for Cancer Research, Medical Oncology
Bethesda, Maryland, United States, 20892
France
Hopital Larrey
Toulouse Cedex, France, 31059
Institut de cancerologie Gustave Roussy
Villejuif Cedex, France, 94805
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milano, (mi), Italy, 20133
Azienda Ospedaliera San Luigi Gonzaga
Orbassano, Italy, 10043

Sponsors and Collaborators

Tiziana Life Sciences, PLC

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Tiziana Life Sciences, PLC
ClinicalTrials.gov Identifier:	NCT01011439 History of Changes
Other Study ID Numbers:	CDKO-125a-006; 2009-014338-79 ( EudraCT Number )
First Posted:	November 11, 2009
Last Update Posted:	July 18, 2017
Last Verified:	July 2017

Keywords provided by Tiziana Life Sciences, PLC:

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; Maleic acid; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action