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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)

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ClinicalTrials.gov Identifier: NCT01266837
Recruitment Status : Completed
First Posted : December 24, 2010
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
iOMEDICO AG

Tracking Information
First Submitted Date  ICMJE December 23, 2010
First Posted Date  ICMJE December 24, 2010
Last Update Posted Date November 14, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2011)
Rate of patients progression free 6 months after start of study treatment [ Time Frame: 2 years after LPI ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
Rate of patients progression free 6 months after start of study treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2011)
Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients [ Time Frame: 2 years after LPI ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2010)
Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label, Single Arm Trial to Characterize Patients With Metastatic RCC Treated With Everolimus After Failure of the First VEGF-targeted Therapy (MARC-2)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Renal Cell Carcinoma
  • Failure of Exactly One Prior VEGF-targeted Therapy
Intervention  ICMJE Drug: Everolimus
10 mg p.o once daily
Other Name: Afinitor
Study Arms  ICMJE single arm
Treatment with Everolimus
Intervention: Drug: Everolimus
Publications * Staehler M, Stöckle M, Christoph DC, Stenzl A, Potthoff K, Grimm MO, Klein D, Harde J, Brüning F, Goebell PJ, Augustin M, Roos F, Benz-Rüd I, Marschner N, Grünwald V. Everolimus after failure of one prior VEGF-targeted therapy in metastatic renal cell carcinoma: Final results of the MARC-2 trial. Int J Cancer. 2021 Apr 1;148(7):1685-1694. doi: 10.1002/ijc.33349. Epub 2020 Oct 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2017)
64
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2010)
80
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date September 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01266837
Other Study ID Numbers  ICMJE CRAD001LDE36T
2010-021370-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party iOMEDICO AG
Study Sponsor  ICMJE iOMEDICO AG
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: Michael Staehler, Dr. med Ludwig-Maximilians-University Munich, Hospital Grosshadern
PRS Account iOMEDICO AG
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP