Carcinoma, Renal CellNCT00538772
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
An observational study of Carcinoma, Renal Cell, run by Kim Chi at 3 sites in Canada.
Trial summary
Purpose: The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Not applicable - blood tests/tissue specimen tests will be undertaken
- How many people
- 0 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2008to Nov 2010
- Phase
- Observational
- 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
Study population: Subjects from Canadian centres who have agreed to participate in the trial entitled "A randomized trial of Temsirolimus and Sorafenib as second line therapy in patients with advanced renal cell carcinoma who have failed first line Sunitinib therapy" will be approached to participate in this Exploratory Biomarker study
Who may be able to join
- All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
- Patients must provide written informed consent.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
BC Cancer Agency - Centre for Southern Interior
Kelowna, British Columbia, V1Y 5L3
BC Cancer Agency - Vancouver
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, V8R 6V5
About this study
Purpose:
The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.
Read the detailed description
It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Not applicable - blood tests/tissue specimen tests will be undertaken
- Keywords
- Metastatic Renal Cell Carcinoma, Biomarkers, Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - blood tests/tissue specimen tests will be undertakenOther
Not applicable - blood tests/tissue specimen tests will be undertaken
| Study group | Role | What they receive |
|---|---|---|
| Biomarker | Not described Receives: Other: Not applicable - blood tests/tissue specimen tests will be undertaken |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Measured: Not available as study withdrawn on November 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startJul 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Chi
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor-investigator, Kim Chi, British Columbia Cancer Agency
- Investigators
- Christian Kollmannsberger, MD, Principal investigator, BC Cancer Agency- Vancouver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538772
- Sponsor's protocol ID
- KNC-001
- Other IDs
- Biomarkers, Metastatic Renal Cell
- Status last verified
- Jul 2019
- First submitted
- 28 Sep 2007
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
- ClinicalTrials.gov ID
- NCT00538772
- Acronym / sponsor ID
- KNC-001
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Metastatic Renal Cell Carcinoma, Biomarkers, Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kim ChiUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jul 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 3 Oct 2007 (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.
Purpose:
The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.
Detailed description
It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biomarker | – | Other: Not applicable - blood tests/tissue specimen tests will be undertaken |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from Canadian centres who have agreed to participate in the trial entitled "A randomized trial of Temsirolimus and Sorafenib as second line therapy in patients with advanced renal cell carcinoma who have failed first line Sunitinib therapy" will be approached to participate in this Exploratory Biomarker study
Key inclusion criteria (2 listed)
- All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
- Patients must provide written informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Not applicable - blood tests/tissue specimen tests will be undertakenNot applicable - blood tests/tissue specimen tests will be undertaken | Other | Biomarker |
Primary outcome
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Time frame: Not available as study withdrawn on November 2010
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
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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.
Christian Kollmannsberger, MD principal investigator
BC Cancer Agency- Vancouver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Renal Cell, run by Kim Chi at 3 sites 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 2 inclusion and 0 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: withdrawn, as of the sponsor's last update on 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made (time frame: Not available as study withdrawn on November 2010). 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 11 Jul 2019.