Cabazitaxel as salvage treatment for cisplatin-resistant germ cell cancer.

Phase 1

• Conditions: Cisplatin-resistant germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum.; MedDRA version: 17.0Level: PTClassification code 10055103Term: Testicular cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004418-32-IT
• Lead Sponsor: Oslo University Hospital - Cancer Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-08
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

-Male patients = 18 years old
-Histologically verified metastatic GCC (germ cell cancer of the testicle or extragonadal GCC originating from retroperitoneum or mediastinum)
-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 platin-based regimens
-ECOG Performance Status (PS): 0-2
-Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 29
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Systemic antitumor treatment within 21 days before study entry
-Simultaneous radiotherapy to the only target lesion
-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 an active or uncontrolled infection
-Patients who have a history of another primary malignancy and are off treatment for = 3 years, with the exception of non-melanoma skin cancer
-Active infection requiring systemic antibiotic-, anti-viral-, or antifungal medication
-Neuropathy = Grade 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of cabazitaxel as monotherapy for the treatment of germ cell cancer. Efficacy is defined as objective responses according to RECIST 1.1.;Secondary Objective: Disease control rate (SD + PR + CR); Progression-free survival; Overall survival; Safety profile; Change of serum tumor markers.;Primary end point(s): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety profile /Adverse Events (AE);Disease control rate (SD + PR + CR);<br>Progression-free survival (PFS) - time from inclusion to the date of disease progression or death from any cause;Overall survival (OS) - time from inclusion to the date of death from any cause;Change of serum tumormarkers (AFP, beta-betaHCG, LDH).;Timepoint(s) of evaluation of this end point: 36 months