Renal Cell CarcinomaPhase 2NCT02626754
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
A Phase 2 study testing Sunitinib malate in people with Renal Cell Carcinoma, run by vghtpe user at 7 sites in Taiwan.
Trial summary
This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Sunitinib malate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 7 sitesTaiwan
- Study dates
- 12 Aug 2015to 2 Jan 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced renal cell carcinoma with histology confirmation
- Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
- ECOG performance status 0 or 1
- Appropriate vital organ functions
Who cannot join
- Prior systemic treatment of mRCC
- Patients treated with any neoadjuvant or adjuvant systemic therapy
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
- Pregnant
- Allergic history to sunitinib
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Kaohsiung Medical University Chung-HO Memorial Hospital
Kaohsiung City, 80756
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Taipei Vterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 11490
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
About this study
This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.
Read the detailed description
Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Sunitinib malate
- Keywords
- Sunitinib, 2/1 schedule, Renal cell carcinoma
- 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 malateDrug
Also called Sutent
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Sunitinib malate, 12.5mg/capsule, 50mg/day Receives: Drug: Sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (safety and tolerability)
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
Measured: 24 months
Secondary outcomes (3)
Objective Response Rate (ORR)
to evaluate the best response rate of sunitinib 2/1 schedule
Measured: 24 months
progression free survival (PFS)
to evaluate the progression-free survival of sunitinib 2/1 schedule
Measured: 24 months
patient reported outcome (PRO)
to evaluate the change of quality of life with sunitinib 2/1 schedule
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start12 Aug 2015
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Why it stopped: In most sites had difficult to recruitting subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- vghtpe user
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Yen-Hwa Chang, M.D. Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626754
- Sponsor's protocol ID
- 2014-10-002A
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
- ClinicalTrials.gov ID
- NCT02626754
- Acronym / sponsor ID
- 2014-10-002A
- Conditions
- Renal Cell Carcinoma
- Keywords
- Sunitinib, 2/1 schedule, Renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In most sites had difficult to recruitting subjects.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- vghtpe userOther government
- Study start
- 12 Aug 2015 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 10 Dec 2015 (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 is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.
Detailed description
Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: Sunitinib malateSunitinib malate, 12.5mg/capsule, 50mg/day |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced renal cell carcinoma with histology confirmation
- Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest
- ECOG performance status 0 or 1
- Appropriate vital organ functions
Key exclusion criteria (5 listed)
- Prior systemic treatment of mRCC
- Patients treated with any neoadjuvant or adjuvant systemic therapy
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated
- Pregnant
- Allergic history to sunitinib
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 malateAlso: SutentSunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest. | Drug | Sunitinib |
Primary outcome
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: 24 months
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
progression free survival (PFS)
Time frame: 24 months
patient reported outcome (PRO)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: In most sites had difficult to recruitting subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Yen-Hwa Chang, M.D. Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
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 Sunitinib malate in people with Renal Cell Carcinoma, run by vghtpe user at 7 sites in Taiwan.
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 5 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: stopped early, as of the sponsor's last update on 26 Jun 2018. 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 Taiwan. 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 was stopped early (reason given: In most sites had difficult to recruitting subjects.). 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?
Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: 24 months). 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 26 Jun 2018.