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

G

Gemin X

Status and phase

Completed
Phase 2
Phase 1

Conditions

Mantle-Cell Lymphoma

Treatments

Drug: Bortezomib
Drug: Obatoclax mesylate

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 3 patient groups

1
Experimental group
Description:
30mg obatoclax, 1.0mg/m2 bortezomib
Treatment:
Drug: Obatoclax mesylate
Drug: Bortezomib
2
Experimental group
Description:
obatoclax 30 mg, bortezomib 1.3 mg/m2
Treatment:
Drug: Obatoclax mesylate
Drug: Bortezomib
3
Experimental group
Description:
Obatoclax 45 mg, Bortezomib 1.3 mg/m2
Treatment:
Drug: Obatoclax mesylate
Drug: Bortezomib

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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