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

Phase 2
18 Years
Open (Enrolling)
Thymic Carcinoma

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Trial Information

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate at 3 months

Outcome Time Frame:

3 months since treatment start

Safety Issue:


Principal Investigator

Marcella Martignoni, BiolSci D

Investigator Role:

Study Director

Investigator Affiliation:

CLIOSS (Nerviano Medical Sciences Group), Italy


United States: Food and Drug Administration

Study ID:




Start Date:

November 2009

Completion Date:

November 2015

Related Keywords:

  • Thymic Carcinoma
  • B3 and C malignant thymoma
  • Carcinoma
  • Thymoma



TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258
NIH, Center for Cancer Research, Medical OncologyBethesda, Maryland  20892