NCT01242631

Brief Summary

The purpose of this study is to determine whether the drug everolimus is effective in the treatment of patients with relapsed cancer of the testis. This is a phase II study where all patients will receive the study drug (everolimus 10 mg daily). The primary endpoint of the study is the rate of patients that have no progressive disease after 12 weeks of treatment. Twenty-five evaluable patients will be treated in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2010

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

3.3 years

First QC Date

November 16, 2010

Last Update Submit

February 24, 2015

Conditions

Testicular CancerGerm Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free rate at 12 weeks

    Percentage of patients that have not progressed after 12 weeks of treatment.

    12 weeks

Secondary Outcomes (3)

  • Objective response rate

    6 months

  • Overall survival

    12 months

  • Safety profile

    6 months

Study Arms (1)

Everolimus 10 mg daily

EXPERIMENTAL
Drug: Everolimus

Interventions

EverolimusDRUG

Everolimus 10 mg orally per day.

Also known as: Afinitor
Everolimus 10 mg daily

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male patients \>= 18 years old.
  • Patients with histologically proven seminomatous or non-seminomatous germ cell cancer
  • Disease progression during cisplatin-based chemotherapy or
  • Disease progression or relapse after high-dose chemotherapy or
  • Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy.
  • Patients must have received prior combination chemotherapy with gemcitabine, oxaliplatin and paclitaxel (GOP). Prior treatment with a combination of two of these drugs is allowed in case of contraindications for GOP.
  • Disease progression at study entry: progressive disease according to RECIST criteria in baseline examinations or tumor marker increase \> 25% within 4 weeks before study entry.
  • ECOG performance status \<= 2.
  • Life expectancy \>= 3 months.
  • Adequate bone marrow function: absolute neutrophil count \>= 1.5 x 109/1, platelets \>= 75 x 109/1, hemoglobin \>= 9 g/dl.
  • Adequate liver function: serum bilirubin: \<= 1.5x ULN, ALT and AST \<= 2.5x ULN. For patients with known liver metastases: AST and ALT \<= 5x ULN.
  • Adequate renal function: serum creatinine \<= 2.0x ULN.
  • Patients must be surgically sterile or must agree to use effective contraception during study treatment.
  • Signed written informed consent.

You may not qualify if:

  • Systemic antitumor treatment within 21 days before study entry.
  • Simultaneous radiotherapy of the only target lesion(s).
  • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traumatic injury, or who have not recovered from the side effects of any of the above
  • Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus).
  • Patients receiving chronic systemic treatment with corticosteroids (dose of \>= 20 mg/day methylprednisone equivalent) or another immunosuppressive agent.
  • Patients with unstable angina pectoris, myocardial infarction \<= 6 months prior to first study treatment, congestive heart failure NYHA III-IV or serious uncontrolled cardiac arrhythmias.
  • Patients with severely impaired lung function: spirometry or DLCO \< 50% of the normal predicted value.
  • Uncontrolled diabetes: fasting serum glucose \> 2.0x ULN.
  • Patients with an active or uncontrolled infection, incl. chronic Hepatitis B or C
  • Patients who have a history of another primary malignancy and are off treatment for \<= 3 years, with the exception of non-melanoma skin cancer.
  • Patients who have participated in another clinical trial within 30 days before study entry.
  • Other serious medical conditions that could impair the ability of the patient to participate in the study.
  • Patients unwilling or unable to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Vivantes Klinikum am Urban

Berlin, 10967, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Universitatsklinikum Schieswig-Holstein - Campus Kiel

Kiel, 24105, Germany

Location

Universitatsklinikum Marburg

Marburg, 35043, Germany

Location

Klinikum Harlaching München

München, 81545, Germany

Location

Universitatsklinikum der Eberhard-Karls-Universitat Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • Fenner M, Oing C, Dieing A, Gauler T, Oechsle K, Lorch A, Hentrich M, Kopp HG, Bokemeyer C, Honecker F. Everolimus in patients with multiply relapsed or cisplatin refractory germ cell tumors: results of a phase II, single-arm, open-label multicenter trial (RADIT) of the German Testicular Cancer Study Group. J Cancer Res Clin Oncol. 2019 Mar;145(3):717-723. doi: 10.1007/s00432-018-2752-z. Epub 2018 Sep 19.

    PMID: 30232558DERIVED

Related Links

MeSH Terms

Conditions

Testicular NeoplasmsNeoplasms, Germ Cell and Embryonal

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Martin H Fenner, MD

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

DE(8)