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Metastatic Renal Cell CarcinomaPhase 2NCT02398552

A Phase II Trila of Sunitinib Schedule 4/2 vs. Shedule 2/1 as First Line Therapy in Metastatic Renal Cell Carcinoma.

A Phase 2 study testing Sunitinib in people with Metastatic Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
6 sitesChina
Study dates
Mar 2015to Mar 2017
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age≥18 years, ≤75 years, male or female
  • Advanced renal cell carcinoma is diagnosed histologically or pathologically
  • Treatment naive at diagnosed
  • At least one measurable tumor lesion (Response Evaluation Criteria In Solid Tumors)
  • Eastern Cooperative Oncology Group（ECOG) performance scale is 0 or 1
  • The expected life span is ≥12 weeks
  • No contraindications for targeted therapy, with enough liver function and renal function and normal ECG recording Peripheral hemogram: neutrophil≥1.5×109/L, Plt≥100×109/L, Hgb≥90g/L Renal function: serum creatinine≤1.5 folds the upper limit of normal (ULN) For patients with non-metastatic liver dysfunction:alanine aminotransferase and aspartate aminotransferase≤2.5 ULN, For patients with metastatic liver dysfunction: alanine aminotransferase and aspartate aminotransferase≤5 ULN
  • The patients participate voluntarily and have signed the informed consent form

Who cannot join

  • Patients who have received any systemic therapy including targeted therapy,immunotherapy,chemotherapy etc at diagnosed.
  • Pregnant and lactating women, or female patients of child-bearing age without taking contraceptive measures
  • Patients with severe acute infection without being controlled effectively or having pyogenic and chronic infections with persistently unhealed wounds
  • Past history of serious heart diseases, including: cardiac function classification ≥NYHA class II, unstable angina pectoris, myocardial infarction, arrhythmia requiring anti-arrhythmic drug therapy (excluding β-blockers or digoxin), and uncontrolled hypertension
  • Patients with a history of HIV infection or active phase of chronic hepatitis B/C
  • negative imaging examination result 4 weeks prior to enrollment)
  • Epilepsy patients requiring drug therapy (e.g. steroids or antiepileptic drugs)
  • A history of allogeneic organ transplantation

Trial locations and contacts

6 sites in 1 country.

Chuanliang Cui, MD contact

0086-10-88196951

1008ccl@163.com

Jun Guo, MD,PHD contact

0086-10-88196317

guoj307@126.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Chinese acadamy of medical science cancer institute & hospital

    Beijing, Beijing Municipality, 100021

    Changling Li, MD, 0086-10-67781331, changllss@yahoo.com.cn

    Changling Li, MD

    Not yet recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Zhisong He, MD, 0086-10-83572211, wyj7074@sohu.com

    Zhisong He, MD

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Chuanliang Cui, MD, 0086-10-88196951, 1008ccl@163.com

    Jun Guo, MD,PHD, 0086-10-88196317, guoj307@126.com

    Recruiting

  • Sun Yat-sen university cancer center

    Guangzhou, Guangdong, 510060

    Fangjian Zhou, MD, 0086-20-87343088, zhoufj@sysucc.org.cn

    Fangjian Zhou, MD

    Not yet recruiting

  • Cancer Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Dingwei Ye, MD, 0086-21-64175590, dwye@163.com

    Dingwei Ye, MD

    Not yet recruiting

  • Tianjin medical university cancer institute & hospital

    Tianjin, Tianjin Municipality, 300060

    Xin Yao, MD, 0086-22-23340123, yaoxin1969@yahoo.com.cn

    Xin Yao, MD

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized Phase II Trila of Sunitinib Four-weeks on/Two-weeks Off Versus Two-weeks on/One-week Off as First Line Therapy in Metastatic Renal Cell Carcinoma.

Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. So investigators conducte this randomized, multi-center phase II study to determine whether a sunitinib regimen of 50 mg/day 2-weeks on/1-week off could provide the same efficacy in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity.

Read the detailed description

Sunitinib given at 50 mg/day on schedule 4/2 (4 weeks on treatment, 2 weeks off) is the standard care for first-line treatment of metastatic renal cell carcinoma, but the schedule was reported with a high rate of dose reduction and dose discontinuation because of the safety profile. Sunitinib 50mg/day on schedule 2/1 (2 weeks on treatment, 1 weeks off) was reported to be associated with significantly decrease toxicities in patients who initially experienced grade 3 or greater toxicity on the schedule 4/2 and could extend treatment duration considerably. Through this research, we would like to explore whether the schedule 2/1 of sunitinib 50 mg/day as first line therapy could provide the same efficacy as standard schedule 4/2 in terms of progression-free survival, objective response, and overall survival, while reducing drug-related toxicity in metastatic renal cell carcinoma patients.

Being tested
Sunitinib
Keywords
metastatic renal cell carcinoma, sunitinib, schedule 2weeks on/1 week off
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.

  • SunitinibDrug

    Also called Sutent

    altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.

Study groups in NCT02398552
Study groupRoleWhat they receive
Sunitinib 50mg/day schedule 4/2Active comparatorSunitinib 50mg/day 4 weeks on/2 weeks off per 6 weeks till disease progression or intolerable toxicity.
Receives: Drug: Sunitinib
Sunitinib 50mg/day schedule 2/1ExperimentalSunitinib 50mg/day 2 weeks on/1 week off per 6 weeks till disease progression or intolerable toxicity.
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progress-free survival (PFS)

    Time from enrollment to the dates of disease progression,death from any cause or last tumor assessment reported between date of first patient enrollment until March 2017 cut off date

    Measured: 2 years

Secondary outcomes (1)

  1. The percentage of patients who can get complete response, partial response.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02398552
Sponsor's protocol ID
BCH-RCC-150212
Status last verified
Feb 2016
First submitted
20 Mar 2015
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. doi: 10.1200/JCO.2008.20.1293. Epub 2009 Jun 1.

    PubMed 19487381

  • Houk BE, Bello CL, Poland B, Rosen LS, Demetri GD, Motzer RJ. Relationship between exposure to sunitinib and efficacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother Pharmacol. 2010 Jul;66(2):357-71. doi: 10.1007/s00280-009-1170-y. Epub 2009 Dec 5.

    PubMed 19967539

  • Neri B, Vannini A, Brugia M, Muto A, Rangan S, Rediti M, Tassi R, Cerullo C. Biweekly sunitinib regimen reduces toxicity and retains efficacy in metastatic renal cell carcinoma: a single-center experience with 31 patients. Int J Urol. 2013 May;20(5):478-83. doi: 10.1111/j.1442-2042.2012.03204.x. Epub 2012 Nov 1.

    PubMed 23113655

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sunitinib in people with Metastatic Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 6 sites in China.

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 8 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 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

Contact Chuanliang Cui, MD (0086-10-88196951, 1008ccl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progress-free survival (PFS) (time frame: 2 years). 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 NCT02398552, which also lists 3 linked publications.

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 1 Mar 2016.

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