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A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma

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Trial Information

A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide

Inclusion Criteria


Inclusion Criteria

- Patients at least 18 years of age

- 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 (if applicable)

- KPS 60% or higher

- Adequate bone marrow function

Exclusion Criteria

- Histology other than astrocytoma grade IV or gliosarcoma

- Tumor foci below the tentorium or cranial vault

- Glioblastoma or gliosarcoma disease with leptomeningeal spread

- Elevated serum aspartate aminotransferase, alanine aminotransferase, or bilirubin

- Moderate to severe hepatic impairment

- Confirmed systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg

- History of orthostatic hypotension

- Renal insufficiency

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

determine the maximum tolerated dose of macitentan in combination with dose-dense temozolomide

Outcome Time Frame:

Phase I Dose Escalation period (Dose-Limiting Toxicity from Baseline to 28 days for each dose level)

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AC-055-115

NCT ID:

NCT01499251

Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Glioblastoma
  • glioblastoma
  • Glioblastoma

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096