Status:
TERMINATED
Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma
Lead Sponsor:
Actelion
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, single arm, Phase 1 study to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide in adult patients with recurrent glioblastoma or gliosa...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed glioblastoma multiforme or gliosarcoma
- Recurrent disease with an:
- interval of at least 3 months following initial radiotherapy and temozolomide
- interval of at least 3 weeks between end of surgery for recurrent disease and start of protocol therapy for patients who have undergone surgery for recurrent disease
- KPS 60% or higher
- Adequate bone marrow function Women of childbearing potential must have a negative serum beta-HCG pregnancy test documented within 14 days prior to study initiation.
- Women of childbearing potential must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment.
- Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception from screening and up to 30 days after discontinuation of study treatment.
- Exclusion Criteria
- Histology other than astrocytoma grade IV (GBM or gliosarcoma)
- Tumor foci below the tentorium or or beyond the cranial vault
- Glioblastoma or gliosarcoma disease with leptomeningeal spread
- Patients with a history of any other cancer, unless in complete remission, and off all therapy for that disease for a minimum of 5 years
- Elevated serum aspartate aminotransferase, alanine aminotransferase, or bilirubin (unless there is medical justification for bilirubin elevation, and aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase are normal)
- Moderate to severe hepatic impairment
- Confirmed systolic blood pressure \< 100 mmHg or diastolic blood pressure \< 50 mmHg
- History of orthostatic hypotension
- Renal insufficiency or serum creatinine above the normal reference range
- Prior chemotherapy for recurrent glioblastoma with nitrosourea compounds or bevacizumab
- Prior focal radiotherapy
- Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic hepatitis; hematological and bone marrow diseases; severe malabsorption)
- No other active cancer
- No concurrent cytochrome P450 3A4 inducers
- No concurrent strong cytochrome P450 3A4 inhibitors
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01499251
Start Date
January 1 2012
End Date
April 1 2016
Last Update
May 5 2016
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030