A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

February 25, 2009 updated by: CASI Pharmaceuticals, Inc.

Phase 2, Open-Label, Safety, and Efficacy Study of 2-Methoxyestradiol Administered to Patients With Plateau Phase or Relapsed Multiple Myeloma

The purpose of the study is to determine the safety and effectiveness of providing 2-methoxyestradiol to patients with plateau phase or relapsed multiple myeloma. Information regarding trough 2ME2 levels will also be collected.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
  2. Be at least 18 years of age.
  3. Have monoclonal plasma cells in the marrow.
  4. have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.

  5. Have laboratory data as specified below:

    • AST and ALT < 2.5 x upper limit of normal (ULN)
    • Alk phos < 5.0 x ULN
    • direct bilirubin < 2 x ULN
    • Creatinine < 3.0 x ULN
    • ANC greater than or equal to 750 cells/mm3
    • Platelets > 25,000/mm3
    • Hemoglobin greater than or equal to 7.0g/dL
  6. Have life expectancy of at least 3 months
  7. Have ECOG performance status of 0, 1, or 2
  8. Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
  9. Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.

Exclusion Criteria:

  1. Be pregnant or nursing.
  2. Have any condition that is likely to detrimentally affect regular follow up.
  3. Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
  4. Have an active infection
  5. Have had major surgery within 21 days of starting 2ME2 administration
  6. Have additional uncontrolled serious medical or psychiatric illness
  7. have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
  8. Have uncontrolled or untreated active bleeding or thrombotic disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Open label, oral administration of 2ME2
Drug: 2-methoxyestradiol
800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.
Other Names:
  • Panzem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine tumor response of 2ME2 administered orally by evaluation of objective responses in patients with plateau phase or relapsed multiple myeloma
Time Frame: At least yearly
At least yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the safety and tolerability of 2ME2 administered orally by evaluation of the frequency, severity, and duration of treatment-emergent adverse events in patients with plateau phase or relapsed multiple myeloma
Time Frame: As reported
As reported
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma
Time Frame: At least yearly
At least yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CASI Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 2, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2009

Last Update Submitted That Met QC Criteria

February 25, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME-CL-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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