cisplatin-resistant germ cell tumor MedDRA version: 18.1 Level: PT Classification code 10061184 Term: Germ cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: OLAPARIB_IRSTIRCCS
Product Code: OLAPARIB_IRSTIRCCS
Pharmaceutical Form: Tablet
INN or Proposed INN: OLAPARIB_IRSTIRCCS
CAS Number: 763113-22-0
Current Sponsor code: OLAPARIB_IRSTIRCCS
O
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the preliminary activity of Olaparib in GCT (Germ Cell Tumors).;Secondary Objective: - To evaluate the safety, PFS (Progression Free Survival) and OS (Overall Survival) of patients with cisplatin-refractory GCT receiving Olaparib - To identify predictive biomarkers (in paraphin-embedded tumor samples and/or plasma) clinical outcome (ORR (Overall Response Rate), PFS, OS);Primary end point(s): to evaluate the preliminary activity of Olaparib in GCT (Germ Cell Tumors).;Timepoint(s) of evaluation of this end point: 30 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)To evaluate the safety, PFS (Progression Free Survival) and OS (Overall Survival) of patients with cisplatin-refractory GCT receiving Olaparib. 2)To identify predictive biomarkers (in paraphin-embedded tumor samples and/or plasma) clinical outcome (ORR (Overall Response Rate), PFS, OS);Timepoint(s) of evaluation of this end point: 30 months | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRCCS IRST
Outcome results
None listed