- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330783
Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients
May 7, 2017 updated by: Jun Guo, Peking University Cancer Hospital & Institute
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
106
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun Guo, MD,PHD
- Phone Number: 0086-10-88196317
- Email: guoj307@126.com
Study Locations
-
-
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Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Principal Investigator:
- Jun Guo, MD,PHD
-
Sub-Investigator:
- Xinan Sheng, MD
-
Beijing, China, 100034
- Recruiting
- Peking University First Hospital
-
Contact:
- Zhisong He, MD
- Phone Number: 0086-10-83572211
- Email: wyj7074@sohu.com
-
Principal Investigator:
- Zhisong He, MD
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Shanghai, China, 200032
- Not yet recruiting
- Cancer Hospital, FuDan University
-
Contact:
- Dingwei Ye, MD
- Phone Number: 0086-21-64175590
- Email: dwye@163.com
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Principal Investigator:
- Dingwei Ye, MD
-
-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Not yet recruiting
- Sun Yat-sen University Cancer Center
-
Contact:
- Fangjian Zhou, MD
- Phone Number: 0086-20-87343088
- Email: zhoufj@sysucc.org.cn
-
Principal Investigator:
- Fangjian Zhou, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab plus Sorafenib
Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
|
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)
Other Names:
400mg twice daily by oral of each 4-week cycle
Other Names:
|
Active Comparator: Sorafenib
Sorafenib 400mg Bid
|
400mg twice daily by oral of each 4-week cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progress-free survival,PFS
Time Frame: 2 years
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival,OS
Time Frame: 3 years
|
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
|
3 years
|
Safety: adverse events
Time Frame: 1 years
|
adverse events
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jun Guo, MD,PHD, Peking University Cancer Hospital & Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: J Clin Oncol. 2008 Sep 10;26(26):4363. Figg, William D [added].
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
January 2, 2015
First Posted (Estimate)
January 5, 2015
Study Record Updates
Last Update Posted (Actual)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 7, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sorafenib
- Bevacizumab
Other Study ID Numbers
- BCH-RCC-141201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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