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Completed

NCT Number: NCT00407303

Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in Combination With Bortezomib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NW Georgia Oncology Centers, Marietta, Georgia, United States

Loading trial locations.

About this study

This is a multi-center, open-label, Phase I study of Obatoclax administered in combination with bortezomib in 3-week cycles to patients with relapsed or refractory Mantle Cell Lymphoma. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patients's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Mantle Cell Lymphoma are allowed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathological confirmation of Mantle Cell Lymphoma (ML)
  • Must have documented relapse or progression following 1 or 2 prior lines of antineoplastic therapy
  • Must have normal organ function
  • Must have the ability to understand and willingness to sign a written informed consent form

Exclusion criteria

  • No other agents or therapies administered with the intent to treat malignancy
  • Patients with prior exposure to obatoclax
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding

Treatment and study plan

Obatoclax mesylate

Drug

30 mg, 45 mg

Other names: (GX15-070MS)

bortezomib

Drug

1.0mg/m2, 1.3 mg/m2

Primary outcomes

  1. Determine the response rate to obatoclax in combination with Bortezomib and characterize the safety profile

    Time frame: 4 weeks to 2 years

Secondary outcomes

  1. Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusion and growth factor requirements

    Time frame: 4 weeks to 2 years

Sponsors and collaborators

Lead sponsor

Gemin X

Industry

Registry information

Official study title

A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered in Combination With Bortezomib to Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2006
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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