A Phase 2 Study With Panzem in Patients With Relapsed or... | NCT00592579

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

NCT00592579

Sponsor

CASI pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Feb 26, 2009Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Relapsed Multiple Myeloma
Plateau Phase Multiple Myeloma

Interventions

2-methoxyestradiol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2001

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 2, 2008

First Posted Date

Jan 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2009

Last Update Posted Date

Feb 26, 2009Estimated

Label	Type	Description	Intervention Names
1	Experimental	Open label, oral administration of 2ME2	Drug: 2-methoxyestradiol

Name	Type	Description	Arm Group Labels	Other Names
2-methoxyestradiol	Drug	800 mg of 2ME2 (capsules) administered orally every 12 hours for a total daily dose of 1600 mg.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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		As reported
To determine the minimum 2ME2 levels achieved in plasma following daily oral administration in patients with plateau phase or relapsed multiple myeloma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Be at least 18 years of age.
Have monoclonal plasma cells in the marrow.
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.
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
Have life expectancy of at least 3 months
Have ECOG performance status of 0, 1, or 2
Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
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:

Be pregnant or nursing.
Have any condition that is likely to detrimentally affect regular follow up.
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.
Have an active infection
Have had major surgery within 21 days of starting 2ME2 administration
Have additional uncontrolled serious medical or psychiatric illness
have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
Have uncontrolled or untreated active bleeding or thrombotic disorder.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Dana Farber Cancer Institute		Boston	Massachusetts	02115	United States
Mayo Clinic

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473