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Metastatic Renal Cell CarcinomaPhase 2NCT02330783

Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients

A Phase 2 study testing Bevacizumab and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 4 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 The sponsor has not verified this record for over two years, so it may be out of date.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

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of… 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?
Bevacizumab and Sorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
4 sitesChina
Study dates
Dec 2014to Dec 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 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 cellcarcinoma is diagnosed histologically or pathologically
  • 1st line treatment of Sunitinib and 2nd line treatment of Everolimus and no more systemic anti-angiogenesis targeted drug therapy
  • Have 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 chemotherapy, 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

  • 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)
Show all 12Show fewer
  • A history of allogeneic organ transplantation
  • Patients with evidence of hemorrhagic constitution or a past history of hemorrhage
  • Patients currently receiving renal dialysis
  • Past or present concomitant tumors with the primary lesions or histological characteristics different from the tumors evaluated in this study, excluding other tumor cured longer than 3 years before enrollment
  • Patients participating in other clinical trials simultaneously
  • Other conditions unsatisfying the inclusion criteria in the investigator's opinions

Trial locations and contacts

4 sites in 1 country.

Xinan Sheng, MD contact

0086-10-88196951

doctor_sheng@126.com

Jun Guo, MD,PHD contact

0086-10-88196317

guoj307@126.com

China4 sites, 4 recruiting

  • Peking University First Hospital

    Beijing, 100034

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

    Zhisong He, MD

    Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Xinan Sheng, MD, 0086-10-88196951, doctor_sheng@126.com

    Jun Guo, MD,PHD

    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, 200032

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

    Dingwei Ye, MD

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus Sorafenib Versus Sorafenib for the Third-line Treatment of Patients With Metastatic Renal Cell Carcinoma

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Read the detailed description

Therapies targeting VEGF and mTOR signalling pathways represent standard first-line and second-line treatment options for patients with metastatic renal cell carcinoma. There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.To the best of the investigators knowledge, GOLD study is the first phase 3 trial in the third-line setting after both VEGF-inhibitor and mTOR-inhibitor drugs.From this study,Sorafenib may be option for the third-line treatment.The Best trial demonstrated that Bevacizumab/sorafenib had best efficacy in advance renal cancer canrcinoma and the VEGF/VEGFR co-inhibition strategy may warrant further investigation possibly with more selective VEGFR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Being tested
Bevacizumab, Sorafenib
Keywords
Metastatic Renal Cell Carcinoma, Third-line treatment, Sorafenib, Bevacizumab
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.

  • BevacizumabDrug

    Also called Avstin

    5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)

  • SorafenibDrug

    Also called Nexavar

    400mg twice daily by oral of each 4-week cycle

Study groups in NCT02330783
Study groupRoleWhat they receive
Bevacizumab plus SorafenibExperimentalBevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
Receives: Drug: Bevacizumab; Drug: Sorafenib
SorafenibActive comparatorSorafenib 400mg Bid
Receives: Drug: Sorafenib

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 31 December 2017 cut of date

    Measured: 2 years

Secondary outcomes (2)

  1. overall survival,OS

    Time from enrollment to the dates of death from any cause or last follow up reported between date of first patient enrollment until 31 December 2017 cut of date

    Measured: 3 years

  2. Safety: adverse events

    adverse events

    Measured: 1 years

Timeline

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

  1. First posted5 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (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
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330783
Sponsor's protocol ID
BCH-RCC-141201
Status last verified
May 2017
First submitted
29 Dec 2014
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

    PubMed 24556040

  • Sosman JA, Puzanov I, Atkins MB. Opportunities and obstacles to combination targeted therapy in renal cell cancer. Clin Cancer Res. 2007 Jan 15;13(2 Pt 2):764s-769s. doi: 10.1158/1078-0432.CCR-06-1975.

    PubMed 17255307

  • Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC. Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol. 2008 Aug 1;26(22):3709-14. doi: 10.1200/JCO.2007.10.8332.

    PubMed 18669456

  • Pal SK, Vogelzang NJ. Sequential treatment strategies and combination therapy regimens in metastatic renal cell carcinoma. Clin Adv Hematol Oncol. 2013 Mar;11(3):146-55.

    PubMed 23598982

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Sorafenib in people with Metastatic Renal Cell Carcinoma, run by Peking University Cancer Hospital & Institute at 4 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 12 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Xinan Sheng, MD (0086-10-88196951, doctor_sheng@126.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 NCT02330783, which also lists 4 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 9 May 2017.

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