An Open Label, Single Arm Trial to Characterize Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of the First VEGF-targeted Therapy (MARC-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by iOMEDICO AG
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
iOMEDICO AG
ClinicalTrials.gov Identifier:
NCT01266837
First received: December 23, 2010
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

A single arm, open-label, multi-center phase IV clinical trial for patients with metastatic renal cell carcinoma, who have progressed on or after the first VEGF-targeted therapy.


Condition Intervention Phase
Metastatic Renal Cell Carcinoma
Patients Who Have Progressed on or After the First VEGF-targeted Therapy
Drug: Everolimus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm Trial to Characterize Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of the First VEGF-targeted Therapy

Resource links provided by NLM:


Further study details as provided by iOMEDICO AG:

Primary Outcome Measures:
  • Rate of patients progression free 6 months after start of study treatment [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients [ Time Frame: 2 years after LPI ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Everolimus
    10 mg p.o once daily
    Other Name: Afinitor
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provide written informed consent
  2. Aged 18 years and above
  3. Histologically or cytologically confirmed predominantly clear cell renal cell carcinoma
  4. Metastatic disease documented by CT or MRI (histological confirmation not mandatory but wishful)
  5. Patients with or without nephrectomy (partial or total)
  6. Patients with at least one measurable lesion at baseline according to RECIST criteria 1.1
  7. Failure of exactly one prior VEGFR-TKI therapy (e.g. sunitinib, sorafenib, pazopanib) for metastatic renal cell carcinoma
  8. ECOG 0-2
  9. Hemoglobin ≥ 9.0 g/dL
  10. Platelet count ≥75,000/μL
  11. Absolute neutrophil count ≥1,5x109/l
  12. Serum creatinine < 2.5 x ULN
  13. Liver function: Serum bilirubin ≤ 1.5 x ULN, AST or ALT ≤ 2.5 x ULN. Patients with suspected liver metastasis: AST and ALT ≤ 5x ULN
  14. Able to swallow the study drug whole as a tablet
  15. Expected life expectancy of at least 6 months
  16. Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of the study treatment or must have a documented condition that prohibits pregnancy (e.g. hysterectomy, post-menopausal).

Exclusion Criteria:

  1. Patients who have received >1 prior VEGFR-TKI therapy or prior therapy with bevacizumab +/- interferon.
  2. VEGFR-TKI therapy within 14 days prior to start of study drug
  3. Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
  4. Patients with a known hypersensitivity to everolimus or other rapamycin (sirolimus, temsirolimus) or to its excipients.
  5. Any condition which, in the opinion of the investigator, would preclude participation in this trial
  6. Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intrapelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry.
  7. Patients who had radiation therapy within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start.
  8. Patients in anticipation of the need for major surgical procedure during the course of the study.
  9. Patients with a serious non-healing wound, ulcer, or bone fracture.
  10. Patients with a history of seizure(s) not controlled with standard medical therapy.
  11. History or clinical evidence of central nervous system (CNS) metastases. Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible:

    1. are asymptomatic and,
    2. have had no evidence of active CNS metastases for ≥ 3 months prior to enrolment (inactive/controlled CNS metastases are allowed) and,
    3. have no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
  12. Patients receiving chronic systemic treatment with corticosteroids (dose of > 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
  13. Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
  14. Impaired liver function classified as Child-Pugh class C.
  15. Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis.
  16. Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
  17. Patients with a known history of HIV seropositivity.
  18. Patients with active bleeding disorders.
  19. Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study such as cardiac angioplasty or stenting, unstable angina pectoris, symptomatic peripheral vascular disease, symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia, any disorders that impair the ability to evaluate the patient or for the patient to complete the study.
  20. Patients who have a history of another primary malignancy and off treatment for ≤ 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) and prostate (T1 - T2).
  21. Female patients who are pregnant or breast feeding.
  22. Men and women of reproductive potential who are not using highly effective birth control methods. Oral contraceptives for female patients and barrier contraceptives are not acceptable. For definition of highly effective birth control methods please refer to section 12.3.6 of this protocol.
  23. Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
  24. Patients unwilling or unable to comply with the protocol.
  25. Exclusion criteria for MRI: intracorporal metal (e.g. incompatible heart valves, pacemakers), contrast media allergy, claustrophobia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266837

Contacts
Contact: Luise Strassl +49 (0)761 15242 ext 75 luise.strassl@iomedico.com

Locations
Germany
Charitè Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Volker Solomon    0049(0)3084452742      
Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden Recruiting
Dresden, Germany, 01307
Contact: Xenia Lueck    0049(0)3514584425      
Urologie - Waldkrankenhaus St. Marien Recruiting
Erlangen, Germany, 91054
Contact: Ruth Schaffer-Ziegelitz    0049(0)91318223498      
Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen Recruiting
Essen, Germany, 45122
Contact: Diana Cortes-Incio    0049(0)2017233155      
Zentrum Innere Medizin, Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Cordula Heise    0049(0)5115324077      
Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Ursula Kayser    0049(0)68411624787      
Klinik für Urologie, Universitätsklinikum Jena Recruiting
Jena, Germany, 07743
Contact: Katharina Schaarschmidt    0049(0)3641935264      
5. Medizinische Klinik, Klinikum Nürnberg Recruiting
Nürnberg, Germany, 90419
Contact: Karin Westphal    0049(0)9113983085      
Sponsors and Collaborators
iOMEDICO AG
Novartis
Investigators
Study Director: Michael Staehler, Dr. med Ludwig-Maximilians-University Munich, Hospital Grosshadern
  More Information

No publications provided

Responsible Party: iOMEDICO AG
ClinicalTrials.gov Identifier: NCT01266837     History of Changes
Other Study ID Numbers: CRAD001LDE36T, 2010-021370-11
Study First Received: December 23, 2010
Last Updated: March 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by iOMEDICO AG:
metastatic renal cell carcinoma
biomarker
Everolimus

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 01, 2014