adult patients with relapsed , refractory or progressive mantle cell lymphoma not appropriate for autologous bone marrow transplantation MedDRA version: 9.1 Level: LLT Classification code 10026800 Term: Mantle cell lymphoma recurrent MedDRA version: 9.1 Level: LLT Classification code 10026801 Term: Mantle cell lymphoma refractory
Conditions
Interventions
Product Name: zarnestra
Product Code: R115777
Pharmaceutical Form: Tablet
INN or Proposed INN: TIPIFARNIB
CAS Number: 192185721
Current Sponsor code: R115777
Other descriptive name: TIPIFARNIB
Concent
Sponsors
GELA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subject 18 years or older. • Initial diagnosis of histologically confirmed mantle cell lymphoma based on the World Health Organization 1997 classification. • Patient not able to receive high dose autologous stem cell transplantation with relapsed, refractory or progressive MCL after prior anti-neoplastic treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions. Biopsy is not required. • Ann Arbor stages I-IV. • At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation. • Eastern Cooperative Oncology Group [ECOG] performance status 0-2. • The following laboratory values at screening: Absolute neutrophil count (ANC) >= 1.0 G/L and Platelets >= 75 G/L Aspartate transaminase (AST) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any other type of lymphoma. • Previous treatment with Zarnestra®. • Anti-neoplastic or radiation therapy within 2 weeks before Day 1 of Cycle 1. • Major surgery within 2 weeks before Day 1 of Cycle 1. • Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 2 weeks before Day 1 of Cycle 1 • Nitrosoureas within 2 weeks before Day 1 of Cycle 1. • Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 4 weeks before Day 1 of Cycle 1. • Less than 30 days since participation in another investigational agent study on Day 1 of cycle 1. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. • Known or suspected allergy to imidazole drugs, such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, or terconazole. • Subjects not adequately recovered from any treatment-related non hematologic toxicity (recovery is defined as NCI CTC v3.0 Grade 0 or 1). • Symptomatic peripheral neuropathy of any grade. • Diagnosed or treated for a malignancy other than NHL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy. Subjects previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score = 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy. • Active systemic infection requiring treatment. • Previously known HIV positive serology • Serious medical or psychiatric illness likely to interfere with participation in this clinical study. • Adult patient under guardian.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure efficacy by evaluation of the overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Zarnestra as single agent, according to criteria based on those developed by Cheson at al;Secondary Objective: • To determine the overall CR rate (CR + CRu) • To determine progression-free survival (PFS) • To determine overall survival • To evaluate the safety and tolerability of Zarnestra® ;Primary end point(s): Efficacy measured by evaluation of the overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Zarnestra® as single agent, according to criteria based on those developed by Cheson at al. | — |
Countries
France
Outcome results
None listed