ew treatment option for refractory testicular cancer.

Phase 1

• Conditions: Refractory histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma germ cell tumours; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000171-24-SK
• Lead Sponsor: árodný onkologický ústav

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-05
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 43

Inclusion Criteria

1)Signed written informed consent
2)Men aged 18 years or older
3)ECOG performance status: 0-1,
4)Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
5)Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
6)Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
7)Primary mediastinal GCTs in first relapse
8)Patient’s disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
9)Measurable disease radiologically
10)Adequate hematologic function defined by ANC > 1500/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
11)Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST < 3 ULN or < 5 in case of liver metastases. For subjects with Gilbert's syndrome bilirubin > 1.5 × ULN is allowed if no symptoms of compromised liver function are present
12)Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 50 ml/min. Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creatinine (mg/dl)]
13)At least 4 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
14)At least 4 weeks must have elapsed since the last major surgery
15)Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
16)Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

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 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43

Exclusion Criteria

1)Patients who do not fit inclusion criteria
2)Other prior malignancy except successfully treated nonmelanoma skin cancer
3)Prior PARP1 inhibitor
4)Other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
5)Female patients
6)Patients infected by the Human Immunodeficiency Virus (HIV)
7)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
8)Inability of oral intake, or drug absorbtion (e.g. malabsorption syndrome)
9)Hypersensitivity to any compound of the drug
10)Sexually active men not using highly effective birth control if their partners are women of child-bearing potential
11)Patients with history of or current CNS metastasis
12)Patients with history of seizures

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy (as measured by 12-months progression-free survival) of gemcitabine, carboplatin and VELIPARIB (ABT-888) in patients with refractory germ cell tumors (GCTs).;Secondary Objective: To describe the favorable response rate, time to progression and toxic effects of VELIPARIB (ABT-888) given with gemcitabine, carboplatin in patients with refractory metastatic germ cell cancer. ;Primary end point(s): 12-months progression-free survival rate;Timepoint(s) of evaluation of this end point: 12 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Response rate<br>Overall survival<br>Toxicity<br>Frequency of grade III and IV adverse events<br>Association between clinical outcome and biomarkers<br>;Timepoint(s) of evaluation of this end point: 12 month