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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01266837
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Failure of Exactly One Prior VEGF-targeted Therapy Drug: Everolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : October 31, 2017

Arm Intervention/treatment
single arm
Treatment with Everolimus
Drug: Everolimus
10 mg p.o once daily
Other Name: Afinitor

Primary Outcome Measures :
  1. Rate of patients progression free 6 months after start of study treatment [ Time Frame: 2 years after LPI ]

Secondary Outcome Measures :
  1. Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients [ Time Frame: 2 years after LPI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01266837

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Charitè Campus Benjamin Franklin
Berlin, Germany, 12203
Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany, 01307
Urologie - Waldkrankenhaus St. Marien
Erlangen, Germany, 91054
Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen
Essen, Germany, 45122
Zentrum Innere Medizin, Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Klinik für Urologie, Universitätsklinikum Jena
Jena, Germany, 07743
5. Medizinische Klinik, Klinikum Nürnberg
Nürnberg, Germany, 90419
Sponsors and Collaborators
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Study Director: Michael Staehler, Dr. med Ludwig-Maximilians-University Munich, Hospital Grosshadern
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: iOMEDICO AG Identifier: NCT01266837    
Other Study ID Numbers: CRAD001LDE36T
2010-021370-11 ( EudraCT Number )
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by iOMEDICO AG:
metastatic renal cell carcinoma
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs