Study With Trabectedin in BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Ovarian Cancer

NCT01772979 | Unknown Phase 2 DMC

• 1 other identifier: MITO15
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter phase II study on trabectedin in advanced or recurrent ovarian cancer patients with BRCA mutation and BRCAness phenotype. The purpose of this study is to determine the feasibility in terms of objective response rate by RECIST version 1.1 (Complete and Partial Response \[CR + PR\]) with trabectedin in patients with BRCA1 or BRCA2 mutation carrier or BRCAness phenotype advanced ovarian cancer patients.

Conditions

BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype

Keywords

Trabectedin; BRCA1 and BRCA2; BRCAness; Ovarian cancer

Outcome Measures

Primary Outcomes (1)

• objective response

  To evaluate the feasibility (in terms of objective response rate by RECIST version 1.1) of Yondelis treatment in recurrent ovarian cancer population selected for BRCA mutation or BRCAness phenotype. The response rate will be compared with an hystorical control arm of recurrent ovarian cancer patients unselected for BRCA mutation or BRCAness phenotype.

  24 months

Secondary Outcomes (3)

• Response

  36 months

• Progression-free survival

  36 months

• safety profile

  36 months

Study Arms (1)

Trabectedin

EXPERIMENTAL

Trabectedin 1.3 mg/m2 q 21 days Patients will receive trabectedin until disease progression or unacceptable toxicity

Drug: Trabectedin

Interventions

Trabectedin DRUG

Also known as: Yondelis

Trabectedin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype.
• Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results).
• BRCA 1 and/or BRCA 2 mutation carriers (patients with established mutation will be included, patients with high personal risk factors will be included after doing the analysis before knowing the results)
• Patients with platinum resistant ovarian cancer, BRCA mutated or with BRCAness phenotype who have previously received at least two previous chemotherapy lines (including platinum rechallenge).
• Definition of platinum resistant: Tumor progression within 6 months of completion of platinum-based therapy (after platinum re-challenge for platinum sensitive recurrence).
• Patient's written informed consent before any clinical trial-specific procedure.
• years-of-age or older.
• Measurable disease as defined in the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
• Hematologic variables:
• Hemoglobin ≥9 g/dL
• Absolute neutrophil count (ANC) ≥1,500/μL, and
• Platelet count ≥100,000/μL.
• Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 30 mL/min
• Creatinine phosphokinase (CPK) ≤ 2.5 ULN.

You may not qualify if:

• \. Prior exposure to trabectedin. 2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone.
• \. Less than 2 prior chemotherapy lines given in patients with partially platinum sensitive, BRCA mutated or BRCAness phenotype, ovarian cancer recurrences (including platinum rechallenge).
• \. Patients with platinum refractory, BRCA mutated or with BRCAness phenotype, ovarian cancer.
• \. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy.
• \. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer.
• \. Known clinically relevant CNS metastases. 8. Other serious illnesses, such as:
• Congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias
• Psychiatric disorder that prevents compliance with protocol
• Active viral hepatitis; or chronic liver disease
• Active infection
• Any other unstable medical conditions

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Heart

Rome, Rome, 00100, Italy

RECRUITING

MeSH Terms

Conditions

Fanconi Anemia, Complementation Group D1; Ovarian Neoplasms

Interventions

Trabectedin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Giovanni Scambia, Prof

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Domenica Lorusso

  National Cancer Institute, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catholic University of Sacred Heart .

CONTACT

+39 0630156279

Catholic University of Sacred Heart, .

CONTACT

+39 0630156279

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Giovanni Scambia

Study Record Dates

• First Submitted: November 17, 2012
• First Posted: January 21, 2013
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 21, 2013

Record last verified: 2012-12

Locations

IT (1)