A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
Inclusion Criteria:
- Advanced cancer not eligible for curative treatment.
- A measurable lesion in the thorax, abdomen or pelvis.
- Normal organ and bone marrow function.
- Able to receive protocol prescribed radiation. Please refer to the protocol for
detailed inclusion criteria.
Exclusion Criteria:
- Overlap of treatment field with a previous radiation field.
- Inability to meet mandated normal tissue radiation dose constraints.
- Brain metastases (unless previously treated and controlled)
- Previous treatment with Sorafenib.
- Poorly controlled Hypertension.
- Unable to swallow sorafenib tablets.
- Intercurrent cardiac dysfunction.
- Uncontrolled intercurrent illness. Please refer to the protocol for detailed
exclusion criteria.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.
Outcome Time Frame:
Outcome is measured prior to each dose escalation.
Safety Issue:
Yes
Principal Investigator
Anthony Brade
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Health Canada
Study ID:
TAP
NCT ID:
NCT00610246
Start Date:
May 2007
Completion Date:
Related Keywords:
- Cancer
- Thorax
- Abdomen
- Pelvis
- Lesion
- Cancer
- Radiation
- Chemotherapy
- Phase 1
- Advanced Cancer
- Sorafenib
- Nexavar
- BAY43-9006
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