EUCTR2014-005095-28-ITActive, not recruitingNot Applicable
Olaparib as salvage treatment for cisplatin-resistant germ cell tumor. - Olaparib as salvage treatment for cisplatin-resistant germ cell tumor.
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 sites29 target enrollmentStarted: March 8, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 29
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Patients = 18 years old
- •2.Histologically verified metastatic gonadal GCT or extragonadal GCT originating from retroperitoneum or mediastinum
- •3.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
- •4. patients who progressed during cisplatin-based therapy and who are not eligible for high-dose chemotherapy
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0-2
- •6. Life expectancy =3 months
- •7. At baseline adequate function of liver, kidneys and bone marrow
- •8. Signed informed consent and expected cooperation of the patients for the treatment and follow up
- •9. At least one measurable lesion that can be accurately assessed by CT/MRI/plain x-ray) at baseline and follow up visits.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
Exclusion Criteria
- •1. Systemic antitumor treatment within 21 days before study entry
- •2. Simultaneous radiotherapy to the only target lesion
- •3. Patients with resting ECG with QTc > 470 msec detected on 2 or more time points within a 24 hour period or family history of long QT syndrome. If ECG demonstrates QTc >470 msec, patient will be eligible only if repeat ECG demonstrates QTc =470 msec
- •4. Patients who have experienced a seizure or seizures within 6 months of study treatment or who are currently being treated with cytochrome P450 enzyme inducing anti-epileptic drugs for seizures.
- •5. Patients with uncontrolled brain metastases.
- •6. Patients receiving prohibited classes of inhibitors of CYP3A4.
- •7. Patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •8. Patients with any acute toxicities due to previous cancer treatment that have not resolved to a NCI-CTCAE v 4.03 grade 0 or 1 with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy.
- •9. Patients affected by myelodysplastic syndrome or acute myeloid leukemia
- •10. Known to be serologically positive for HIV and receiving antiretroviral therapy
- •11. Known seropositive for active viral infection with hepatitis B virus (HBV) (patients who are HBsAg negative, anti-HBs positive and/or Anti-HBc positive, but viral DNA negative are eligible)
- •12. Known seropositive for active infection with hepatitis C virus (HCV)
- •13. Patients unwilling or unable to comply with the protocol
- •14. 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
- •15. Patients with an active or uncontrolled infection
- •16. Patients who have a history of another primary malignancy and are off treatment for = 3 years, with the exception of non-melanoma skin cancer
- •17. 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 within 6 weeks
- •18. Patients who have participated in another interventional clinical trial within 30 days before study entry
- •19. Other serious medical conditions that could impair the ability of the patient to participate in the study
- •20. Active infection requiring systemic antibiotic-, anti-viral-, or anti-fungal medication
- •21. Active cancer (other than GCT) including prior malignancy from which the patient has been disease-free for =3 years (except superficial basal cell skin cancer)
- •22. Patients with a known hypersensitivity to the combination/comparator agent
- •23. Patients with uncontrolled seizures.
Investigators
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