Metastatic Renal Cell CarcinomaPhase 2NCT00570882
Study of Sunitinib Administered as 4/2 vs. 2/1 Schedule in Advanced Renal Cell Carcinoma (RCC)
A Phase 2 study testing Sunitinib 2/1 and Sunitinib 4/2 in people with Metastatic Renal Cell Carcinoma, run by Asan Medical Center at 3 sites in South Korea.
Trial summary
This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population. 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?
- Sunitinib 2/1 and Sunitinib 4/2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Oct 2007to Jun 2014
- 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 confirmation of renal cell carcinoma with a clear cell histologic component
- Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
- ECOG performance status 2 or better
- Age 18 years or older
- Adequate bone marrow, hepatic, and renal function
- Life expectancy of > 3 months
- Singed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Who cannot join
- Known spinal cord compression or carcinomatous meningitis
- Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
- Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
- Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
- Pregnancy or breast feeding.
- Other severe acute or chronic medical or psychiatric condition
- Prior treatment on sunitinib, sorafenib, or bevacizumab.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Daegu Catholic University Hospital
Daegu
Yeungnam University Medical Center
Daegu
Asan Medical Center
Seoul, 138-736
About this study
Official title: A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma
This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Sunitinib 2/1, Sunitinib 4/2
- Keywords
- Renal cell carcinoma, Sunitinib, phase II study, Randomized study
- 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.
Sunitinib 2/1Drug
Sunitinib 50 mg PO 2 weeks followed by 1 week rest
Sunitinib 4/2Drug
Sunitinib 50 mg PO 4 weeks followed by 2 week rest
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib 4/2 | Active comparator | Sunitinib 50 mg PO 4-week on and 2-week off Receives: Drug: Sunitinib 4/2 |
| Sunitinib 2/1 | Experimental | Sunitinib 50 mg PO 2-week on 1-week off Receives: Drug: Sunitinib 2/1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
Measured: 12 months
Secondary outcomes (5)
Overall response rate
RECIST v.1.1 will be used to assess tumor responses
Measured: 6 months
quality of life
EORTC QLQ C30 and EQ5D will be used to assess the quality of life
Measured: 12 months
Progression free survival
Measured: 12 months
Overall survival
Measured: 36 months
Adverse events
CTC AE v.3.0
Measured: about 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2014
- Study completionJun 2014
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.
- More trials run by Asan Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JLee, Asan Medical Center
- Investigators
- Jae-Lyun Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570882
- Sponsor's protocol ID
- UOSG_AMC_0701
- Status last verified
- Sep 2014
- First submitted
- 10 Dec 2007
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7.
PubMed 26347107
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Of Sunitinib Administered Daily For 4 Weeks, Followed By 2-Week Rest Vs. 2-Week On And 1-Week Off In Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00570882
- Acronym / sponsor ID
- UOSG_AMC_0701
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- Renal cell carcinoma, Sunitinib, phase II study, Randomized study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Dec 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.
This study is to evaluate the efficacy, safety, and feasibility of sunitinib in 4/2 and 2/1 regimen in previously untreated metastatic RCC to select the most promising regimen, which should be used in further studies of this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunitinib 4/2 | Active comparator | Drug: Sunitinib 4/2Sunitinib 50 mg PO 4-week on and 2-week off |
| Sunitinib 2/1 | Experimental | Drug: Sunitinib 2/1Sunitinib 50 mg PO 2-week on 1-week off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmation of renal cell carcinoma with a clear cell histologic component
- Patients must present with stage IV disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- Measurable disease according to RECIST criteria are required but patients with evaluable lesions without measurable lesions are allowed to be enrolled to this study
- ECOG performance status 2 or better
- Age 18 years or older
Key exclusion criteria (7 listed)
- Known spinal cord compression or carcinomatous meningitis
- Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, or in situ carcinoma of cervix uteri
- Hypertension that cannot be controlled by medications (blood pressure > 150/90 mmHg despite optimal medical therapy)
- Treatment with anticonvulsant agents and treatment with therapeutic doses of coumadin currently or within 2 weeks prior to first day of sunitinib administration. Low dose coumadin for DVT prophylaxis is permitted (up to 2 mg/day).
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Sunitinib 2/1Sunitinib 50 mg PO 2 weeks followed by 1 week rest | Drug | Sunitinib 2/1 |
| Sunitinib 4/2Sunitinib 50 mg PO 4 weeks followed by 2 week rest | Drug | Sunitinib 4/2 |
Primary outcome
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death)
Time frame: 12 months
From the date of randomization to the date of progressive disease, treatment withdrawal, or death from any cause, which came first.
5 secondary outcomes
Overall response rate
Time frame: 6 months
quality of life
Time frame: 12 months
Progression free survival
Time frame: 12 months
Overall survival
Time frame: 36 months
Adverse events
Time frame: about 12 months
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 25 Sep 2014.
- Derived from this study: PubMed 26347107Lee JL, Kim MK, Park I, Ahn JH, Lee DH, Ryoo HM, Song C, Hong B, Hong JH, Ahn H. RandomizEd phase II trial of Sunitinib four weeks on and two weeks off versus Two weeks on and One week off in metastatic clear-cell type REnal cell carcinoma: RESTORE trial. Ann Oncol. 2015 Nov;26(11):2300-5. doi: 10.1093/annonc/mdv357. Epub 2015 Sep 7.
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 1/2
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
RecruitingPhase 1
A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Metastatic Solid Tumor, Recurrent Solid Tumor
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
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.
Jae-Lyun Lee, MD, PhD principal investigator
Asan Medical Center
3 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 Sunitinib 2/1 and Sunitinib 4/2 in people with Metastatic Renal Cell Carcinoma, run by Asan Medical Center at 3 sites in South Korea.
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 8 inclusion and 7 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 25 Sep 2014. 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 South Korea. 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?
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?
Treatment failure rate (progressive disease, treatment withdrawal due to unacceptable toxicities, or any death) (time frame: 12 months). 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 NCT00570882, 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 2014.