Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01180049
First received: August 9, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).


Condition Intervention Phase
Non-Hodgkin's Lymphoma (NHL)
Drug: temsirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 4 Study Comparing 2 Doses Of Intravenous Temsirolimus In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Estimate independently assessed Progression Free Survival (PFS) [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate Overall survival [ Time Frame: every 3 months from last dose of study drug ] [ Designated as safety issue: No ]
  • Estimate objective response rate [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
  • Estimate PFS per investigator [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
  • Assess safety, including infection and bleeding [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
  • Quantify potential of temsirolimus to alter disposition of desipramine, a substrate of CYP2D6 metabolism [ Time Frame: first 2 weeks of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly Drug: temsirolimus
175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Other Name: Torisel
Active Comparator: temsirolimus (Torisel) 75mg weekly Drug: temsirolimus
75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
Other Name: Torisel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have confirmed mantle cell lymphoma diagnosis.
  • Have measurable disease.
  • Have received at least 2 prior treatment, which may include stem cell transplant.
  • Have adequate organ and bone marrow function.
  • There are other criteria--please discuss with your doctor.

Exclusion Criteria:

  • Had any prior treatment with temsirolimus or mTOR inhibitor.
  • Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
  • Has active or untreated brain or central nervous system metastases.
  • There are other criteria--please discuss with your doctor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180049

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 49 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01180049     History of Changes
Other Study ID Numbers: 3066K1-4438, B1771007
Study First Received: August 9, 2010
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Mantle Cell Lymphoma
non-Hodgkin lymphoma (NHL)
temsiolimus

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 14, 2014