Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01266837
Other study ID # CRAD001LDE36T
Secondary ID 2010-021370-11
Status Completed
Phase Phase 4
First received December 23, 2010
Last updated November 10, 2017
Start date March 2011
Est. completion date October 31, 2017

Study information

Verified date November 2017
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 31, 2017
Est. primary completion date September 26, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Everolimus
10 mg p.o once daily

Locations

Country Name City State
Germany Charitè Campus Benjamin Franklin Berlin
Germany Klinik und Poliklinik für Urologie , Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden Dresden
Germany Urologie - Waldkrankenhaus St. Marien Erlangen
Germany Klinik für Innere Medizin (Tumorforschung), Universitätsklinikum Essen Essen
Germany Zentrum Innere Medizin, Medizinische Hochschule Hannover Hannover
Germany Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes Homburg
Germany Klinik für Urologie, Universitätsklinikum Jena Jena
Germany 5. Medizinische Klinik, Klinikum Nürnberg Nürnberg

Sponsors (2)

Lead Sponsor Collaborator
iOMEDICO AG Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients progression free 6 months after start of study treatment 2 years after LPI
Secondary Relation between biomarkers and clinical benefit (response, stable disease and progression/ no clinical benefit) of patients 2 years after LPI
See also
  Status Clinical Trial Phase
Completed NCT00930033 - Clinical Trial to Assess the Importance of Nephrectomy Phase 3
Recruiting NCT05863351 - Focused Radiation Versus Systemic Therapy for Kidney Cancer Patients With Limited Metastasis, SOAR Study Phase 3
Not yet recruiting NCT06284564 - A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) Phase 2
Completed NCT00414765 - Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma Phase 4
Active, not recruiting NCT03149822 - Study of Pembrolizumab and Cabozantinib in Patients With Metastatic Renal Cell Carcinoma Phase 1/Phase 2
Recruiting NCT03647878 - Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.
Completed NCT01517243 - Phase II Study of Alternating Sunitinib and Temsirolimus Phase 2
Withdrawn NCT03927248 - PAC-1 for Treatment of Refractory, Metastatic Kidney Cancer Phase 1/Phase 2
Terminated NCT02122003 - Second Line Sorafenib After Pazopanib in Patients With RCC Phase 2
Completed NCT01182142 - Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients Phase 2
Completed NCT00630409 - Phase II Clinical Trial of Gemcitabine and Doxil® for Metastatic Renal Cell Carcinoma Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Completed NCT04076787 - Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Active, not recruiting NCT04467021 - Cancer and Blood Pressure Management, CARISMA Study N/A
Recruiting NCT05119335 - A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma Phase 1/Phase 2
Completed NCT02282579 - Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
Terminated NCT02071641 - Phase II Study of Sunitinib Rechallenge in Patients With Metastatic Renal Cell Carcinoma Phase 2
Completed NCT01731158 - Sequential Therapy in Metastatic Renal Cell Carinoma Phase 2
Terminated NCT01342627 - Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma Phase 2
Active, not recruiting NCT01274273 - Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer Phase 2