A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Piramal Enterprises Limited

Criteria

Inclusion Criteria:

• Age ≥18 years

• Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping

• Documented progression or relapse after at least 1 line of prior chemotherapy

• Presence of measurable disease

• ECOG performance status 0, 1, or 2

• Life expectancy of at least 3 months

• Ability to understand and the willingness to sign a written informed consent document (ICD)

• Full recovery from all prior treatment toxicities of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1

Exclusion Criteria:

• Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration

• Prior treatment with monoclonal antibodies or any radio- or toxin- immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study.

• Prior allogeneic stem cell transplantation within 1 year of study drug administration

• Current or prior CNS lymphoma

• QTc > 450 msec

• Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration

• Presence of active and serious comorbidity and uncontrolled illness other than MCL

• History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer

• Hemoglobin <8.0 gm/dL

• Absolute neutrophil count <1000/mm3

• Platelet count <50,000/mm3

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × institutional upper limit of normal (ULN) (> 5 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)

• Total bilirubin, >1.5 × institutional ULN (> 3 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease)

• Serum creatinine >1.5 × institutional ULN

• Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B

• Pregnant or lactating women

• Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (one of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study