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

NCT ID: NCT01011439

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-22
• Study Completion Date: 2018-12-17

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.

Detailed Description

The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter 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.

Conditions

Thymic Carcinoma

Study Design

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

Study Groups

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

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

• 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

• 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

Glen Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Scottsdale Clinical Research Institute, USA

Benjamin Besse, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Gustave Roussy, Villejuif, France

Julien Mazières, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Larrey CHU, Toulouse, France

Silvia Novello, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Luigi Gonzaga, Orbassano, Italy

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

Locations

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, United States

NIH, Center for Cancer Research, Medical Oncology

Bethesda, Maryland, United States

Hopital Larrey

Toulouse, , France

Institut de cancerologie Gustave Roussy

Villejuif, , France

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, (MI), Italy

Azienda Ospedaliera San Luigi Gonzaga

Orbassano, , Italy

Countries

United States; France; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: CDKO-125a-006_ALG_V1

View Document

Document Type: Statistical Analysis Plan: CDKO-125a-006_TLG_V1

View Document

Other Identifiers

2009-014338-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDKO-125a-006

Identifier Type: -

Identifier Source: org_study_id