NCT00086216

Brief Summary

This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started May 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2004

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 21, 2007

Status Verified

December 1, 2007

First QC Date

June 28, 2004

Last Update Submit

December 20, 2007

Conditions

Multiple Myeloma

Keywords

Multiple myeloma

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study is to identify the maximum tolerated dose

    1 year

Secondary Outcomes (1)

  • The secondary objective of this study is to measure the pharmacokinetics of

    1 year

Interventions

AtiprimodDRUG

Oral, once a day, 14 days on 14 days off

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented history of multiple myeloma,
  • failed at least two prior regimens for multiple myeloma,
  • years of age or older,
  • ECOG(Zubrod)PS of 0 to 2,
  • screening evaluation for determining eligibility prior to enrollment,
  • signed informed consent form,

You may not qualify if:

  • concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
  • renal insufficiency (serum creatinine levels of \> 2mg/dL),
  • mucosal bleeding,
  • any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.
  • clinically relevant active infection or co-morbid medical conditions.
  • prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
  • patients with non-secretory myeloma.
  • as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

azaspirane

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Gary Jacob, PhD

    Callisto Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 28, 2004

First Posted

June 30, 2004

Study Start

May 1, 2004

Study Completion

November 1, 2007

Last Updated

December 21, 2007

Record last verified: 2007-12

Locations

US(1)