CancerPhase 1NCT00610246
A Study of Radiation With Sorafenib in Advanced Cancer
A Phase 1 study testing Sorafenib in people with Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
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 group | Role | What they receive |
|---|---|---|
| Sorafenib and Radiation | Experimental | Eligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive 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. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.
Measured: Outcome is measured prior to each dose escalation.
Secondary outcomes (1)
Sorafenib with radiation treatment efficacy
To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria.
Measured: 12 weeks from initiation of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Brade, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610246
- Sponsor's protocol ID
- TAP
- Other IDs
- DDPDRO-003
- Status last verified
- Feb 2019
- First submitted
- 24 Jan 2008
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)
- ClinicalTrials.gov ID
- NCT00610246
- Acronym / sponsor ID
- TAP
- Conditions
- Cancer
- Keywords
- Thorax, Abdomen, Pelvis, Lesion, Cancer, Radiation, Chemotherapy, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Radiation | Experimental | Drug: SorafenibEligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive 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. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibSorafenib 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. | Drug | Sorafenib and Radiation |
Primary outcome
Maximum Tolerated Dose
Time frame: 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.
1 secondary outcome
Sorafenib with radiation treatment efficacy
Time frame: 12 weeks from initiation of study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Brade principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sorafenib in people with Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: Outcome is measured prior to each dose escalation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.