Study of Gemcitabine, Carboplatin and VELIPARIB (ABT-888) in Refractory Testicular Germ Cell Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02860819
• Date of registration: 14/07/2016
• Prospective Registration: Yes
• Primary sponsor: National Cancer Institute, Slovakia
• Public title: Study of Gemcitabine, Carboplatin and VELIPARIB (ABT-888) in Refractory Testicular Germ Cell Cancer
• Scientific title: Phase II Study of Gemcitabine, Carboplatin and VELIPARIB (ABT-888) in Refractory Testicular Germ Cell Cancer
• Date of first enrolment: August 1, 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02860819
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Slovakia

Contacts

• Name: Michal Mego, Assoc.Prof
• Affiliation: National Cancer Institute (NCI)

Key inclusion & exclusion criteria

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

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 absorption (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



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Testicular Cancer

Intervention(s)

Drug: Carboplatin

Drug: Gemcitabine

Drug: Veliparib

Primary Outcome(s)

Percentage of patients that will be free of disease progression according to RECIST criteria 12-months after the first administration of the treatment. [Time Frame: 12-months]

Secondary Outcome(s)

Response rate [Time Frame: 6-weeks]

Frequency of grade III and IV adverse events [Time Frame: 3-weeks]

Median overall survival [Time Frame: 12 months]

Median progression-free survival [Time Frame: 12-months]

Secondary ID(s)

GCTSK004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors