fallopian tube cancers of BRCA mutated or BRCAness phenotype treatedwith Trabectedin compared to a standard treatment.

Phase 1

• Conditions: Patient with recurrence of ovarian tumor, fallopian tube or peritoneumprimitive that has a BRCA mutation or BRCAness phenotype.; MedDRA version: 20.0Level: LLTClassification code 10033271Term: Ovarian neoplasiaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10016183Term: Fallopian tube cancer NOSSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10026340Term: Malignant neoplasm of peritoneum, unspecifiedSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004472-30-ES
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-21
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

Inclusion criteria
1. Female of age 18 years or older
2. Histologically or cytologically documented invasive epithelial ovarian
cancer, primary peritoneal carcinoma, or fallopian tube cancer
3. Platinum resistant or sensitive patients with either:
a. BRCA mutated patients
b. BRCAness phenotype patients: patients who have received and
responded (subsequent PFI>6 months) to at least 2 previous platinum
based chemotherapy lines
c. Platinum sensitive patients who are not able to receive or not willing
to receive other platinum treatments
4. Measurable and evaluable disease per RECIST 1.1(Subjects with
isolated rising CA-125 without radiologically visible disease are
excluded)
5. ECOG performance status 0 or 1
6. No limits in the number of previous chemotherapy lines, previous
treatment with parp inhibitors is allowed
7. Left Ventricular Ejection Fraction (LVEF) = institutional lower limit
normal
8. Life expectancy of at least 3 months
9. Adequate organ functions:
a. Hematopoietic: Absolute neutrophil count = 1,500/mm3;
Platelet count = 100,000/mm3; Hemoglobin = 9 g/dl
b. Hepatic: AST and ALT = 1.5 times upper limit of normal
(ULN)* ; Alkaline Phosphatase = 2.5 times ULN* ; Bilirubin = 1.5 times
ULN. NOTE: * = 3 times ULN if liver metastases are present
c. Renal: Creatinine Clearance = 45 ml/min or Serum Creatinine =1.5 x
ULN
d. Serum Albumin >2.5 g/dl
10. No other invasive malignancy within the past 3 years except nonmelanoma
skin cancer or in situ cervical cancer (patients with previous
cancers may be enrolled providing that no recurrences have be reported
in the last 3 years)
11. Written Informed Consent
12. Adequately recovered from the acute toxicity of any prior treatment
13. For agents in the standard arm, also refer to the local prescribing
information
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

Exclusion criteria
1. Prior exposure to trabectedin
2. Known hypersensitivity to any of the components of the trabectedin
i.v. formulation or dexamethasone
3. Subjects with borderline ovarian cancer, ie. Subject with low
malignant potential tumors are excluded
4. At least 2 reported responses to platinum (i.e. subsequent recurrences
at least 6 months after the first and the second platinum based
treatment), unless BRCA mutation is documented.
5. Less than 4 weeks from last dose of therapy with any investigational
agent, or chemotherapy
6. History of another neoplastic disease (except basal cell carcinoma or
cervical carcinoma in situ adequately treated) unless in remission for 3
years or longer
7. Known clinically relevant CNS metastases, unless treated and
asymptomatic
8. Other serious illnesses, such as:
a. Congestive heart failure or angina pectoris; myocardial infarction
within 1 year before enrolment; uncontrolled arterial hypertension or
arrhythmias.
b. Psychiatric disorder that prevents compliance with protocol.
c. Active viral hepatitis; or chronic liver disease.
d. Active infection.
e. Any other unstable medical conditions.

Study & Design

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