Carcinoma, Renal CellPhase 1/2NCT00389285
Study of Recombinant Interleukin 21 in Combination With Sorafenib for Metastatic Renal Cell Carcinoma
A Phase 1/2 study testing rIL-21 only and rIL-21 + sorafenib in people with Carcinoma, Renal Cell, run by ZymoGenetics at 3 sites in United States.
Trial summary
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC). 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?
- rIL-21 only and rIL-21 + sorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to May 2009
- Phase
- Phase 1/2
- 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
- Diagnosis of RCC of predominantly clear cell histology
- Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
- At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
- Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)
Who cannot join
- Presence of acute infection or other significant systemic illness
- Central nervous system involvement by malignancy
- History of other cancer within 5 years
- Previously received rIL-21 or sorafenib
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama
Birmingham, Alabama, 35294
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Premiere Oncology of Arizona
Scottsdale, Arizona, 85260
About this study
Official title: A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma
The purpose of the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).
Read the detailed description
This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- rIL-21 only, rIL-21 + sorafenib
- Keywords
- Carcinoma, renal cell, interleukin-21, sorafenib, Immunotherapy
- 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.
rIL-21 onlyDrug
Part 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course
rIL-21 + sorafenibDrug
Part 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily)
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile, including incidence and severity of adverse events
Measured: During treatment and 28 days after last dose of rIL-21
Secondary outcomes (3)
Objective response rate at recommended dose of rIL-21
Measured: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
Progression-free survival at recommended dose of rIL-21
Measured: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
Pharmacokinetic profiles of rIL-21 and sorafenib
Measured: rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2009
- Study completionMay 2009
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 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZymoGenetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Naomi Hunder, MD, Study director, ZymoGenetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389285
- Sponsor's protocol ID
- 494F01
- Status last verified
- May 2009
- First submitted
- 16 Oct 2006
- Last updated
- 27 May 2009
- Results posted
- No
Publications
Bhatia S, Curti B, Ernstoff MS, Gordon M, Heath EI, Miller WH Jr, Puzanov I, Quinn DI, Flaig TW, VanVeldhuizen P, Byrnes-Blake K, Freeman JA, Bittner R, Hunder N, Souza S, Thompson JA. Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study. J Immunother Cancer. 2014 Jan 27;2:2. doi: 10.1186/2051-1426-2-2. eCollection 2014.
PubMed 24829759
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Dose Escalation Study to Assess the Safety and Pharmacokinetics of Recombinant Interleukin 21 (rIL-21) Administered Concomitantly With Sorafenib (Nexavar) in Subjects With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00389285
- Acronym / sponsor ID
- 494F01
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Carcinoma, renal cell, interleukin-21, sorafenib, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- ZymoGeneticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Oct 2006 (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 the study is to evaluate whether recombinant IL-21 used in combination with sorafenib is safe for patients with metastatic renal cell carcinoma (RCC).
Detailed description
This is a Phase 1/2 open-label dose-escalation study of rIL-21 given in combination with sorafenib to patients with metastatic RCC. The Phase 1 part of this study will estimate the maximum tolerated dose of rIL-21 given for 1 treatment course (consisting of two 5-day cycles of rIL-21) in combination with a standard dose of sorafenib administered during a 6-week treatment course. Increasing doses of rIL-21 will be studied sequentially in different groups of patients. The Phase 2 part of the study will further evaluate the safety and preliminary antitumor activity of rIL-21 at the dose recommended from Phase 1 in combination with sorafenib. Patients will be evaluated for safety over the course of the study. Disease evaluation (tumor restaging) will be performed during the last week of each 6-week treatment course. Patients with stable disease or better at this evaluation may go on to receive additional treatment courses. Patients may be in the study for 2 to 7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of RCC of predominantly clear cell histology
- Either no prior treatment or a maximum of 2 prior treatment regimens for metastatic RCC that included no more than 1 treatment regimen targeting the vascular endothelial growth factor (VEGF) pathway (Phase 1 only)
- At least 1 but no more than 2 prior systemic therapies for metastatic RCC that included no more than 1 therapy targeting the VEGF pathway (Phase 2 only)
- Disease measurable per the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase 2 only)
Key exclusion criteria (4 listed)
- Presence of acute infection or other significant systemic illness
- Central nervous system involvement by malignancy
- History of other cancer within 5 years
- Previously received rIL-21 or sorafenib
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 |
|---|---|---|
| rIL-21 onlyPart 1: rIL-21, IV, Day 1-5 and 15-19 of each 6-week treatment course | Drug | – |
| rIL-21 + sorafenibPart 2: rIL-21 IV, Day 1-5 and 15-19 of each 6-week treatment course + sorafenib (up to 400 mg taken orally twice daily) | Drug | – |
Primary outcome
Safety profile, including incidence and severity of adverse events
Time frame: During treatment and 28 days after last dose of rIL-21
3 secondary outcomes
Objective response rate at recommended dose of rIL-21
Time frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
Progression-free survival at recommended dose of rIL-21
Time frame: Every 6 weeks during treatment and then every 3 months after last dose of rIL-21 until 3 months after median survival is reached
Pharmacokinetic profiles of rIL-21 and sorafenib
Time frame: rIL-21: During treatment and 15 days after dosing; sorafenib: During treatment and 22 days after dosing
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 27 May 2009.
- Derived from this study: PubMed 24829759Bhatia S, Curti B, Ernstoff MS, Gordon M, Heath EI, Miller WH Jr, Puzanov I, Quinn DI, Flaig TW, VanVeldhuizen P, Byrnes-Blake K, Freeman JA, Bittner R, Hunder N, Souza S, Thompson JA. Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study. J Immunother Cancer. 2014 Jan 27;2:2. doi: 10.1186/2051-1426-2-2. eCollection 2014.
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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.
Naomi Hunder, MD study director
ZymoGenetics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rIL-21 only and rIL-21 + sorafenib in people with Carcinoma, Renal Cell, run by ZymoGenetics at 3 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 4 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: finished, as of the sponsor's last update on 27 May 2009. 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 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 combined 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.
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?
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?
Safety profile, including incidence and severity of adverse events (time frame: During treatment and 28 days after last dose of rIL-21). 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 NCT00389285, 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 27 May 2009.