Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

NCT ID: NCT01301391

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-02
• Study Completion Date: 2018-12-17

Brief Summary

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

Detailed Description

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Conditions

Malignant Thymoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Milciclib

Milciclib Maleate capsules

Group Type: EXPERIMENTAL

Milciclib Maleate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PHA-848125AC

Eligibility Criteria

Inclusion Criteria

• Signed and dated IRB/Approved Informed Consent
• Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease
• Presence of measurable disease
• Age >=18 years old
• 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 (with the exception of myasthenia gravis), 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tiziana Life Sciences LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arun Rajan, MD.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Marina C. Garassino, MD.

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Giuseppe Giaccone, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Gergetown University Hospital

Locations

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

NIH, Center for Cancer Research, Medical Oncology

Bethesda, Maryland, United States

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, (mi), Italy

Countries

United States; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: CDKO-125a-007_ALG_V1

View Document

Document Type: Statistical Analysis Plan: CDKO-125a-007_TLG_V1

View Document

Other Identifiers

CDKO-125a-007

Identifier Type: -

Identifier Source: org_study_id