A Study of Radiation With Sorafenib in Advanced Cancer

A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00610246

Enrollment

Registered

2008-02-07

Start date

2007-05-31

Completion date

2011-05-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Thorax, Abdomen, Pelvis, Lesion, Cancer, Radiation, Chemotherapy, Phase 1, Advanced Cancer, Sorafenib, Nexavar, BAY43-9006

Brief summary

The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.

Interventions

DRUGSorafenib

Sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. Dose level 1 is 200mg of sorafenib. If full oral dose (400mg orally, twice a day) is reached in a given cohort then an additional dose level will open where sorafenib treatment is extended following radiation for a total of eight weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Maximum Tolerated Dose	Outcome is measured prior to each dose escalation.	To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.

Secondary

Measure	Time frame	Description
Sorafenib with radiation treatment efficacy	12 weeks from initiation of study treatment.	To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026