Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00004020

Trial Description

start of 1:1-Block title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

MARC-2

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004020
  •   2013/06/07
  •   2010/12/23
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2010-021370-11 
  •   NCT01266837  (ClinicalTrials.gov)
  •   CRAD001LDE36T  (iOMEDICO AG)
  •   2010-021370-11 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Metastatic Renal Cell Carcinoma
  •   Failure of Exactly One Prior VEGF-targeted Therapy
  •   C64 -  Malignant neoplasm of kidney, except renal pelvis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Everolimus
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Rate of patients progression free 6 months after start of study treatment; time frame: 2 years after LPI

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients; time frame: 2 years after LPI

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2011/03/31
  •   80
  •   Multicenter trial
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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).

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • iOMEDICO AG
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Novartis
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Ludwig-Maximilians-University Munich, Hospital Grosshadern
    • Michael Staehler, Dr. med 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Ludwig-Maximilians-University Munich, Hospital Grosshadern
    • Michael Staehler, Dr. med 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
start of 1:n-Block dynamic attributes

Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
    start of 1:1-Block address
    • [---]*
    end of 1:1-Block address
    start of 1:1-Block address contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact
  • Further contact 
    start of 1:1-Block address
    • [---]*
    end of 1:1-Block address
    start of 1:1-Block address contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact
  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
end of 1:n-Block dynamic attributes
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2016/01/14
* This entry means the parameter is not applicable or has not been set.