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A Study of Radiation With Sorafenib in Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00610246
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 21, 2011
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Sorafenib Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
Study Start Date : May 2007
Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Sorafenib
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.

Primary Outcome Measures :
  1. To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities. [ Time Frame: Outcome is measured prior to each dose escalation. ]

Secondary Outcome Measures :
  1. To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria. [ Time Frame: 12 weeks from initiation of study treatment. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610246

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Anthony Brade Princess Margaret Hospital, Canada

Responsible Party: Dr Anthony Brade, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00610246     History of Changes
Other Study ID Numbers: TAP
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 21, 2011
Last Verified: October 2011

Keywords provided by University Health Network, Toronto:
Phase 1
Advanced Cancer

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs