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Clinical Trials/EUCTR2014-001274-34-IT
EUCTR2014-001274-34-IT
Active, not recruiting
Phase 1

Phase II trial of abiraterone acetate in patients with relapsed and/or metastatic, castration resistant, salivary gland cancers.

Fondazione IRCCS Istituto Nazionale dei Tumori0 sites24 target enrollmentMay 8, 2014
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DrugsZytiga

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori
Enrollment
24
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 8, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Signed informed consent
  • •\- Histologically or cytologically confirmed salivary glands cancer.
  • •\- At least, one target lesion defined as RECIST 1\.1 (clear progression of disease is required in the presence of one target lesion previously treated with radiotherapy
  • •\- Clinical and/or radiological progression of disease on ADT
  • •\- No limits are required for the number of previous chemotherapy lines
  • •\- Age \=18 years
  • •\- Eastern Cooperative Oncology Group (ECOG) performance status of \=2
  • •\- Hemoglobin \= 9\.0 g/dL independent of transfusion
  • •\- Platelet count \= 100,000/µL
  • •\- Serum albumin \= 3\.0 g/dL

Exclusion Criteria

  • •\- Received abiraterone acetate within the last 5 years
  • •\- Serious or uncontrolled co\-existent non\-malignant disease, including active and uncontrolled infection
  • •\- Abnormal liver functions consisting of any of the following:
  • •Serum bilirubin \= 1\.5 x ULN (except for subjects with documented Gilbert’s disease, for whom the upper limit of serum bilirubin is 3 mg/dL)
  • •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \= 2\.5 x ULN
  • •Patients with ALT and/or AST not exceeding 5X ULN due to liver mets can be enrolled
  • •\- Uncontrolled hypertension (systolic blood pressure \=160 mmHg or diastolic blood pressure \=95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti\-hypertensive therapy.
  • •\- Active or symptomatic viral hepatitis or chronic liver disease
  • •\- History of pituitary or adrenal dysfunction
  • •\- Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction (LVEF) of \<50% at baseline

Outcomes

Primary Outcomes

Not specified

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