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Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Renal Cell; Adenocarcinoma, Renal Cell; Nephroid Carcinoma,; Hypernephroid

Intervention: RAD001(everolimus) (Drug); interferon alfa-2a (Drug); bevacizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Clinical Details

Official title: A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab

Secondary outcome:

Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab

Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab

Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab

Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths

Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units

Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%

Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients with metastatic renal cell carcinoma 2. Patients with at least one measurable lesion 3. Patients with progressive metastatic renal cell carcinoma 4. Patients who had a prior partial or complete nephrectomy 5. Patients with a Karnofsky Performance Status ≥70%. 6. Adequate bone marrow function 7. Adequate liver function 8. Adequate renal function 9. Adequate coagulation profile Exclusion Criteria: 1. 4 weeks post-major surgery 2. Patients who had radiation therapy within 28 days prior to start of study 3. Patients in need for major surgical procedure during the course of the study. 4. Patients with a serious non-healing wound, ulcer, or bone fracture. 5. Patients with a history of seizure(s) not controlled with standard medical therapy. 6. Patients who have received prior systemic treatment for their metastatic RCC. 7. Patients who received prior therapy with VEGF pathway inhibitor 8. Patients who have previously received systemic mTOR inhibitors 9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients. 10. Patients with history or current central nervous system (CNS) metastases or spinal cord compression. 11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment. 12. Patients with proteinuria at screening. 13. Patients with inadequately controlled hypertension 14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin 15. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent. 16. Patients with a known history of HIV 17. Patients with hypersensitivity to interferon alfa-2a or any component of the product. 18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism 19. Patients who have any severe and/or uncontrolled medical conditions or other conditions 20. Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA 21. Patients who have a history of another primary malignancy ≤ 3 years 22. Female patients who are pregnant or breast feeding 23. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start. 24. Patients unwilling to or unable to comply with the protocol Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Bruxelles 1200, Belgium

Novartis Investigative Site, Bruxelles 1070, Belgium

Novartis Investigative Site, Charleroi 6000, Belgium

Novartis Investigative Site, Kortrijk 8500, Belgium

Novartis Investigative Site, Leuven 3000, Belgium

Novartis Investigative Site, Liege 4000, Belgium

Novartis Investigative Site, Olomouc 775 20, Czech Republic

Novartis Investigative Site, Prague 140 00, Czech Republic

Novartis Investigative Site, Cairo, Egypt

Novartis Investigative Site, Avignon 84000, France

Novartis Investigative Site, Bordeaux Cedex 33075, France

Novartis Investigative Site, Caen Cedex 14021, France

Novartis Investigative Site, La Roche sur Yon Cedex 85925, France

Novartis Investigative Site, Montellier cedex 5 34298, France

Novartis Investigative Site, Nantes cedex 2 44202, France

Novartis Investigative Site, Reims 51100, France

Novartis Investigative Site, Rouen Cedex 76031, France

Novartis Investigative Site, Strasbourg Cedex 67010, France

Novartis Investigative Site, Suresnes 92150, France

Novartis Investigative Site, Toulouse Cedex 9 31059, France

Novartis Investigative Site, Berlin 13055, Germany

Novartis Investigative Site, Berlin 10117, Germany

Novartis Investigative Site, Dessau 06846, Germany

Novartis Investigative Site, Essen 45122, Germany

Novartis Investigative Site, Frankfurt 60488, Germany

Novartis Investigative Site, Frankfurt 60590, Germany

Novartis Investigative Site, Göttingen 37075, Germany

Novartis Investigative Site, Hamburg 20246, Germany

Novartis Investigative Site, Hannover 30625, Germany

Novartis Investigative Site, Heidelberg 69115, Germany

Novartis Investigative Site, Leipzig 04109, Germany

Novartis Investigative Site, Mainz 55131, Germany

Novartis Investigative Site, Tübingen 72076, Germany

Novartis Investigative Site, HongKong, Hong Kong

Novartis Investigative Site, Shatin, New Territories, Hong Kong

Novartis Investigative Site, Budapest 1086, Hungary

Novartis Investigative Site, Budapest 1122, Hungary

Novartis Investigative Site, Napoli 80131, Italy

Novartis Investigative Site, Daegu 705-703, Korea, Republic of

Novartis Investigative Site, Seoul 136 705, Korea, Republic of

Novartis Investigative Site, Taegu 700 - 721, Korea, Republic of

Novartis Investigative Site, Leiden 2333 ZA 2333, Netherlands

Novartis Investigative Site, Moscow 115478, Russian Federation

Novartis Investigative Site, Moscow 125284, Russian Federation

Novartis Investigative Site, Saint Petersburg 191104, Russian Federation

Novartis Investigative Site, Saint-Petersburg 197758, Russian Federation

Novartis Investigative Site, Singapore 258500, Singapore

Novartis Investigative Site, Bratislava 833 10, Slovakia

Novartis Investigative Site, Johannesburg 2196, South Africa

Novartis Investigative Site, Pretoria 0001, South Africa

Novartis Investigative Site, Barcelona 08025, Spain

Novartis Investigative Site, Madrid 28034, Spain

Novartis Investigative Site, Madrid 28041, Spain

Novartis Investigative Site, Santander 39008, Spain

Novartis Investigative Site, Zaragoza 50009, Spain

Novartis Investigative Site, Bern 3010, Switzerland

Novartis Investigative Site, Chur 7000, Switzerland

Novartis Investigative Site, Lin-Kou 33305, Taiwan

Novartis Investigative Site, Taichung 40705, Taiwan

Novartis Investigative Site, Taipei 10002, Taiwan

Novartis Investigative Site, Taipei 114, Taiwan

Novartis Investigative Site, Bangkok 10330, Thailand

Novartis Investigative Site, Songkla 90110, Thailand

Novartis Investigative Site, Adana 01330, Turkey

Novartis Investigative Site, Altunizade 34662, Turkey

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Novartis Investigative Site, Antalya 07070, Turkey

Novartis Investigative Site, Balcova / Izmir 35340, Turkey

Novartis Investigative Site, Bursa 16059, Turkey

Novartis Investigative Site, Mecidiyekoy/Istanbul 34394, Turkey

Novartis Investigative Site, Glasgow G12 0YN, United Kingdom

Novartis Investigative Site, Southampton SO16 6YD, United Kingdom

Novartis Investigative Site, Jaen, Andalucía 23007, Spain

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas 72703, United States

Novartis Investigative Site, Brescia, BS 25123, Italy

Novartis Investigative Site, Cremona, CR 26100, Italy

Novartis Investigative Site, Catanzaro, CZ 88100, Italy

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3), Duarte, California 91010-3000, United States

University of California at Los Angeles Dept. of Hem/Oncology, Los Angeles, California 90095, United States

USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3, Los Angeles, California 90053, United States

Novartis Investigative Site, Santander, Cantabria 39008, Spain

Novartis Investigative Site, Strasbourg, Cedex 67091, France

Novartis Investigative Site, Firenze, FI 50134, Italy

Novartis Investigative Site, Goyang, Gyeonggi-do 410-769, Korea, Republic of

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of

Novartis Investigative Site, Milano, MI 20133, Italy

Novartis Investigative Site, Modena, MO 41100, Italy

Karmanos Cancer Institute Dept.of KarmanosCancerInst (5), Detroit, Michigan 48201, United States

Novartis Investigative Site, Northwood, Middlesex HA6 2RN, United Kingdom

Nevada Cancer Institute Dept. of Nevada Cancer (3), Las Vegas, Nevada 89135, United States

Novartis Investigative Site, Perugia, PG 06129, Italy

Novartis Investigative Site, Aviano, PN 33081, Italy

Novartis Investigative Site, Pavia, PV 27100, Italy

St. Luke's Hospital and Health Network St. Luke's Cancer Network, Bethlehem, Pennsylvania, United States

Novartis Investigative Site, Rio de Janeiro, RJ 20230-130, Brazil

Novartis Investigative Site, Roma, RM 00128, Italy

Novartis Investigative Site, Roma, RM 00152, Italy

Novartis Investigative Site, Porto Alegre, RS 90035-903, Brazil

Novartis Investigative Site, Porto Alegre, RS 90610-000, Brazil

Novartis Investigative Site, Obninsk, Russia 249036, Russian Federation

Novartis Investigative Site, Ribeirao Preto, SP 14015-130, Brazil

Novartis Investigative Site, Santo Andre, SP 09060-650, Brazil

Novartis Investigative Site, São Paulo, SP 01246-000, Brazil

Novartis Investigative Site, Trento, TN 38100, Italy

Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan

Las Colinas Hematology Oncology Grapevine, Irving, Texas 75038, United States

Novartis Investigative Site, Negrar, VR 37024, Italy

Seattle Cancer Care Alliance Dept. of SCCA, Seattle, Washington 98109-1023, United States

Additional Information

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Starting date: November 2008
Last updated: May 27, 2015

Page last updated: August 23, 2015

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