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

NCT00843050 | Terminated Phase 2 Results

• 1 other identifier: P276-00/23/08
• Study Type: interventional
• Target: 13
• Locations: 2 countries
• Sites: 20

Brief 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.

Conditions

Mantle Cell Lymphoma

Keywords

CKD inhibitor; Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Best Overall Objective Response Rate

  The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.

  End of every 2 cycles and end of the study treatment

Secondary Outcomes (2)

• Duration of Response

  End of the study treatment

• Time to Progression

  End of study treatment

Study Arms (1)

P276-00

EXPERIMENTAL

P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity

Drug: P276-00

Interventions

P276-00 DRUG

P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity

P276-00

Eligibility Criteria

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

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

Sponsors & Collaborators

• Piramal Enterprises Limited: lead

Study Sites (20)

Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Phoenix, Arizona

Phoenix, Arizona, 85054, United States

Location

Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona

Scottsdale, Arizona, 85259, United States

Location

College of Medicine, Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Gabrail Cancer Center Research

Dover, Ohio, 44622, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5505, United States

Location

Cancer Care Centers of South Texas

New Braunfels, Texas, 78130, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute, 2000 Circle of Hope, Room 2145

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Department of Medicine, University of Washington

Seattle, Washington, 98195, United States

Location

Dept of Hematology/Oncology, University of Wisconsin- Madison

Madison, Wisconsin, 53792-5156, United States

Location

St. Johns Medical College & Hospital

Bangalore, Karnataka, 34, India

Location

Malabar Institute of Medical Sciences

Calicut, Kerala, 16, India

Location

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, 400 026, India

Location

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Cancer Care Clinic and Hospital

Nagpur, Maharashtra, 440012, India

Location

Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 10029, India

Location

Meenakshi mission hospital and research centre

Madurai, Tamil Nadu, 625107, India

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

P276-00

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The Sponsor has terminated the study based on interim results. All subjects were off study at the time of termination. There are no major safety or tolerability concerns from this study. The study results published here are preliminary results.

Results Point of Contact

• Title: Dr. Alan Hatfield
• Organization: Piramal Healthcare Limited

alan.hatfield@piramal.com

02230275000

Study Officials

• Brad Kahl, MD

  Director of the Lymphoma Service and Associate Professor of Medicine, University of Wisconsin- Madison

  PRINCIPAL INVESTIGATOR

• Gabrail Nashat, MD

  CEO, President, Gabrail Cancer Center

  PRINCIPAL INVESTIGATOR

• Martha Glenn, MD

  Associate Professor of Medicine, Huntsman Cancer Institute, Salt Lake City

  PRINCIPAL INVESTIGATOR

• Andre Goy, MD

  Director of Lymphoma and Deputy Director of Cancer Center, Hackensack University Medical Center, Hackensack

  PRINCIPAL INVESTIGATOR

• Roger Lyons, MD

  President, Cancer Care Centers of South Texas , San Antonio

  PRINCIPAL INVESTIGATOR

• Nishitha Reddy, MD

  Vanderbilt University Medical Center, Nashville

  PRINCIPAL INVESTIGATOR

• Reena Nair, MD

  Professor and Medical Oncologist, Tata Memorial Hospital, Mumbai, India

  PRINCIPAL INVESTIGATOR

• Anand Pathak, MD

  Medical Oncologist, Cancer Care Clinic and Hospital, Nagpur, India

  PRINCIPAL INVESTIGATOR

• Vinod Raina, MD

  Head Dept of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

• N K Warrier, MD

  Senior Consultant Oncologist, Malabar Institute of Medical Sciences, Calicut, India

  PRINCIPAL INVESTIGATOR

• Cecil Ross, MD

  Consultant Oncologist, St. Johns Medical College & Hospital, Bangalore, India

  PRINCIPAL INVESTIGATOR

• Kirushna kumar, MD

  Consultant Oncologist, Meenakshi mission hospital and research centre, Madurai, India

  PRINCIPAL INVESTIGATOR

• S H Advani, MD

  Consultant Oncologist, Jaslok Hospital and Research Centre, Mumbai, India

  PRINCIPAL INVESTIGATOR

• Patrick Johnston, MD

  Associate Professor of Medicine, College of Medicine, Mayo Clinic, Rochester, USA

  PRINCIPAL INVESTIGATOR

• Ajay Gopal, MD

  Associate Professor of Medicine, Department of Medicine, University of Washington, Seattle, Washington.

  PRINCIPAL INVESTIGATOR

• Craig Reeder, MD

  Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2012
• Last Updated: July 27, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-06

Locations

IN (7); US (13)