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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Nerviano Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT01301391
First received: February 15, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Malignant Thymoma
Drug: Milciclib Maleate
Phase 2

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 Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

Resource links provided by NLM:


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:
  • Adverse Events (NCI CTCAE) and hematological and blood chemistry parameters [ Time Frame: All cycles from enrollment to 28 days after last treatment ] [ Designated as safety issue: Yes ]
  • Objective Response Rate (ORR) by RECIST [ Time Frame: All treatment period ] [ Designated as safety issue: No ]
  • Disease Control rate (ORR+SD Rate) [ Time Frame: All treatment period ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: All treatment period ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: All treatment period ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milciclib
Milciclib Maleate capsules
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301391

Locations
United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Giuseppe Giaccone, MD    202-687-7072      
Principal Investigator: Giuseppe Giaccone, MD         
United States, Maryland
NIH, Center for Cancer Research, Medical Oncology Active, not recruiting
Bethesda, Maryland, United States, 20892
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Recruiting
Milano, (mi), Italy, 20133
Contact: Marina C. Garassino, MD.    +39 02 2390 ext 3813    marina.garassino@istitutotumori.mi.it   
Principal Investigator: Marina C. Garassino, MD.         
Sponsors and Collaborators
Nerviano Medical Sciences
Investigators
Study Director: Marcella Martignoni, Chem. Pharm. D. PhD CLIOSS (Nerviano Medical Sciences Group), 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

No publications provided

Responsible Party: Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT01301391     History of Changes
Other Study ID Numbers: CDKO-125a-007
Study First Received: February 15, 2011
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nerviano Medical Sciences:
B3 and C malignant thymoma

Additional relevant MeSH terms:
Thymoma
Thymus Neoplasms
Lymphatic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014