Overview

This trial is active, not recruiting.

Condition thymic carcinoma
Treatment milciclib maleate
Phase phase 2
Sponsor Tiziana Life Sciences, PLC
Start date March 2009
End date June 2016
Trial size 60 participants
Trial identifier NCT01011439, 2009-014338-79, CDKO-125a-006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
milciclib maleate PHA-848125AC
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.

Primary Outcomes

Measure
Progression-free survival rate at 3 months
time frame: 3 months since treatment start

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
Principal investigator Glen Weiss, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Tiziana Life Sciences, PLC.
Location data was received from the National Cancer Institute and was last updated in May 2016.