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

Stopped early · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00843050

Run by

Piramal Enterprises Limited

People needed

13

Starts

2009-11-01

Expected to finish

2012-08-01

Last updated by the study team

2012-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona — Phoenix, Arizona, United States
• Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona — Scottsdale, Arizona, United States
• College of Medicine, Mayo Clinic — Rochester, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Gabrail Cancer Center Research — Canton, Ohio, United States
• Gabrail Cancer Center Research — Dover, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Cancer Care Centers of South Texas — New Braunfels, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• Huntsman Cancer Institute, 2000 Circle of Hope, Room 2145 — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• Department of Medicine, University of Washington — Seattle, Washington, United States
• Dept of Hematology/Oncology, University of Wisconsin- Madison — Madison, Wisconsin, United States
• St. Johns Medical College & Hospital — Bangalore, Karnataka, India
• Malabar Institute of Medical Sciences — Calicut, Kerala, India
• Jaslok Hospital and Research Centre — Mumbai, Maharashtra, India
• Tata Memorial Hospital — Mumbai, Maharashtra, India
• Cancer Care Clinic and Hospital — Nagpur, Maharashtra, India
• Institute Rotary Cancer Hospital, All India Institute of Medical Sciences — New Delhi, National Capital Territory of Delhi, India
• Meenakshi mission hospital and research centre — Madurai, Tamil Nadu, India

Full record on ClinicalTrials.gov

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