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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Thymoma

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Trial Information

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


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

Type of Study:

Interventional

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:

No

Principal Investigator

Marcella Martignoni, Biol.Sci. D.

Investigator Role:

Study Director

Investigator Affiliation:

CLIOSS (Nerviano Medical Sciences Group), Italy

Authority:

United States: Food and Drug Administration

Study ID:

CDKO-125a-007

NCT ID:

NCT01301391

Start Date:

January 2011

Completion Date:

December 2015

Related Keywords:

  • Malignant Thymoma
  • B3 and C malignant thymoma
  • Thymoma

Name

Location

NIH, Center for Cancer Research, Medical Oncology Bethesda, Maryland  20892