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Metastatic Renal Cell CarcinomaPhase 4MARC-2NCT01266837

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

A Phase 4 study testing Everolimus in people with Metastatic Renal Cell Carcinoma and Failure of Exactly One Prior VEGF-targeted Therapy, run by iOMEDICO AG at 8 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Everolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
8 sitesGermany
Study dates
Mar 2011to 31 Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent
  • Aged 18 years and above
  • Histologically or cytologically confirmed predominantly clear cell renal cell carcinoma
  • Metastatic disease documented by CT or MRI (histological confirmation not mandatory but wishful)
  • Patients with or without nephrectomy (partial or total)
  • Patients with at least one measurable lesion at baseline according to RECIST criteria 1.1
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  • Failure of exactly one prior VEGFR-TKI therapy (e.g. sunitinib, sorafenib, pazopanib) for metastatic renal cell carcinoma
  • ECOG 0-2
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥75,000/μL
  • Absolute neutrophil count ≥1,5x109/l
  • Serum creatinine < 2.5 x ULN
  • 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
  • Able to swallow the study drug whole as a tablet
  • Expected life expectancy of at least 6 months
  • 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).

Who cannot join

  • Patients who have received >1 prior VEGFR-TKI therapy or prior therapy with bevacizumab +/- interferon.
  • VEGFR-TKI therapy within 14 days prior to start of study drug
  • Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus).
  • Patients with a known hypersensitivity to everolimus or other rapamycin (sirolimus, temsirolimus) or to its excipients.
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial
  • 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.
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  • 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.
  • Patients in anticipation of the need for major surgical procedure during the course of the study.
  • Patients with a serious non-healing wound, ulcer, or bone fracture.
  • Patients with a history of seizure(s) not controlled with standard medical therapy.
  • 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:
  • are asymptomatic and,
  • have had no evidence of active CNS metastases for ≥ 3 months prior to enrolment (inactive/controlled CNS metastases are allowed) and,
  • have no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin)
  • Patients receiving chronic systemic treatment with corticosteroids (dose of > 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable.
  • Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN.
  • Impaired liver function classified as Child-Pugh class C.
  • Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis.
  • Liver disease such as chronic active hepatitis or chronic persistent hepatitis.
  • Patients with a known history of HIV seropositivity.
  • Patients with active bleeding disorders.
  • 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.
  • 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).
  • Female patients who are pregnant or breast feeding.
  • 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.
  • Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
  • Patients unwilling or unable to comply with the protocol.
  • Exclusion criteria for MRI: intracorporal metal (e.g. incompatible heart valves, pacemakers), contrast media allergy, claustrophobia

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Charitè Campus Benjamin Franklin

    Berlin, 12203

  • Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 01307

  • Urologie - Waldkrankenhaus St. Marien

    Erlangen, 91054

  • Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen

    Essen, 45122

  • Zentrum Innere Medizin, Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Klinik für Urologie, Universitätsklinikum Jena

    Jena, 07743

  • 5. Medizinische Klinik, Klinikum Nürnberg

    Nuremberg, 90419

Other trials in Germany

About this study

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

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.

Being tested
Everolimus
Keywords
metastatic renal cell carcinoma, biomarker, Everolimus
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EverolimusDrug

    Also called Afinitor

    10 mg p.o once daily

Study groups in NCT01266837
Study groupRoleWhat they receive
single armOtherTreatment with Everolimus
Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients progression free 6 months after start of study treatment

    Measured: 2 years after LPI

Secondary outcomes (1)

  1. Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients

    Measured: 2 years after LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2010 (estimated)
  2. Study startMar 2011
  3. Primary completion26 Sep 2017
  4. Study completion31 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01266837
Sponsor's protocol ID
CRAD001LDE36T
Other IDs
2010-021370-11
Acronym
MARC-2
Status last verified
Nov 2017
First submitted
23 Dec 2010
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Staehler M, Stockle M, Christoph DC, Stenzl A, Potthoff K, Grimm MO, Klein D, Harde J, Bruning F, Goebell PJ, Augustin M, Roos F, Benz-Rud I, Marschner N, Grunwald 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.

    PubMed 33070307

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus in people with Metastatic Renal Cell Carcinoma and Failure of Exactly One Prior VEGF-targeted Therapy, run by iOMEDICO AG at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients progression free 6 months after start of study treatment (time frame: 2 years after LPI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01266837, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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