Metastatic Renal Cell CarcinomaPhase 2NCT00740441
A Phase II Study of AS1411 in Renal Cell Carcinoma
A Phase 2 study testing AS1411 in people with Metastatic Renal Cell Carcinoma, run by Antisoma Research at 7 sites in United States.
Trial summary
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- AS1411
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
- Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)
Who cannot join
- Collecting duct histology
- A history of bleeding disorders or currently taking oral vitamin K antagonise medication
- Unstable brain metastases
- History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
St Francis Hospital
Beech Grove, Indiana, 46107
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29403
City of Hope
Duarte, California, 91010
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202
University of California, Davis Cancer Center
Sacramento, California, 95817
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- AS1411
- Keywords
- renal cell carcinoma, rcc, kidney cancer
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1411Drug
AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AS1411 treatment Receives: Drug: AS1411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Overall Response Rate to AS1411
Secondary outcomes (6)
To measure progression free survival with AS1411
To measure time to disease progression with AS1411
To measure the duration of overall response and stable disease with AS1411
To determine the safety and tolerability of two cycles of AS1411
To assess the pharmacokinetic profile of AS1411
To assess pharmacodynamic markers of AS1411
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Greg Smith, MD, Principal investigator, WVU Medicine Thomas HospitalsHarry Drabkin, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740441
- Sponsor's protocol ID
- AS1411-C-202
- Status last verified
- Sep 2009
- First submitted
- 22 Aug 2008
- Last updated
- 25 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenberg JE, Bambury RM, Van Allen EM, Drabkin HA, Lara PN Jr, Harzstark AL, Wagle N, Figlin RA, Smith GW, Garraway LA, Choueiri T, Erlandsson F, Laber DA. A phase II trial of AS1411 (a novel nucleolin-targeted DNA aptamer) in metastatic renal cell carcinoma. Invest New Drugs. 2014 Feb;32(1):178-87. doi: 10.1007/s10637-013-0045-6. Epub 2013 Nov 16.
PubMed 24242861
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00740441
- Acronym / sponsor ID
- AS1411-C-202
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- renal cell carcinoma, rcc, kidney cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Aug 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 aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AS1411AS1411 treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
- Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)
Key exclusion criteria (4 listed)
- Collecting duct histology
- A history of bleeding disorders or currently taking oral vitamin K antagonise medication
- Unstable brain metastases
- History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)
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 |
|---|---|---|
| AS1411AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles | Drug | A |
Primary outcome
To determine the Overall Response Rate to AS1411
6 secondary outcomes
To measure progression free survival with AS1411
To measure time to disease progression with AS1411
To measure the duration of overall response and stable disease with AS1411
To determine the safety and tolerability of two cycles of AS1411
To assess the pharmacokinetic profile of AS1411
To assess pharmacodynamic markers of AS1411
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2009.
- Derived from this study: PubMed 24242861Rosenberg JE, Bambury RM, Van Allen EM, Drabkin HA, Lara PN Jr, Harzstark AL, Wagle N, Figlin RA, Smith GW, Garraway LA, Choueiri T, Erlandsson F, Laber DA. A phase II trial of AS1411 (a novel nucleolin-targeted DNA aptamer) in metastatic renal cell carcinoma. Invest New Drugs. 2014 Feb;32(1):178-87. doi: 10.1007/s10637-013-0045-6. Epub 2013 Nov 16.
Related trials for Metastatic Renal Cell Carcinoma
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Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
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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.
Greg Smith, MD principal investigator
WVU Medicine Thomas Hospitals
Harry Drabkin, MD principal investigator
Medical University of South Carolina
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS1411 in people with Metastatic Renal Cell Carcinoma, run by Antisoma Research at 7 sites in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To determine the Overall Response Rate to AS1411. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740441, which also lists 1 linked publication.
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 25 Sep 2009.