Everolimus in Refractory Testicular Germ Cell Cancer

NCT01466231 | Completed Phase 2 DMC

• 1 other identifier: GCTSK002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Conditions

Germ Cell Tumor

Keywords

refractory germ cell cancer; everolimus

Outcome Measures

Primary Outcomes (1)

• Response rate

  according RECIST criteria version 1.1

  36 month

Secondary Outcomes (7)

• Favorable response rate

  36 month

• Clinical benefit rate

  36 month

• Progression-free survival

  36 month

• Toxicity

  36 month

• Frequency of grade III and IV adverse events

  36 month

Study Arms (1)

everolimus 10 mg po daily

EXPERIMENTAL

everolimus 10 mg po daily

Drug: Everolimus

Interventions

Everolimus DRUG

Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Also known as: Afinitor

everolimus 10 mg po daily

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Men aged 18 years or older
• ECOG performance status: 0-2,
• Histological confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
• Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
• Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
• Primary mediastinal GCTs in first relapse
• Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
• Measurable disease radiological
• Adequate hematologic function defined by WBC \> 4000/mm3, platelet count \> 100 000/mm3 and hemoglobin level \> 9g/dl.
• Adequate liver function defined by a total bilirubin level \< 1.5 ULN, and ALT, AST \< 2,5 ULN and adequate renal function defined by serum creatinine ≤ 1.5 x ULN.
• At least 2 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
• At least 4 weeks must have elapsed since the last major surgery
• Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, -

You may not qualify if:

• Other prior malignancy except successfully treated non melanoma skin cancer
• Prior treatment with mTOR inhibitor
• No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
• Female patients,
• Patients infected by the Human Immunodeficiency Virus (HIV),
• Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study,
• Inability of oral intake, or drug absorption (e.g. malabsorption syndrome)
• Hypersensitivity to any compound of the drug,
• Sexually active men not using effective birth control if their partners are women of child-bearing potential.
• Patients with active CNS metastasis

Sponsors & Collaborators

• National Cancer Institute, Slovakia: lead

Study Sites (1)

National Cancer Institute

Bratislava, 83310, Slovakia

Location

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Jozef Mardiak, Prof

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

• Michal Mego, Ass.prof.

  National Cancer Institute, Slovakia

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 7, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

SL (1)