NCT00806065

Brief Summary

Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

December 9, 2008

Last Update Submit

February 2, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of ENMD-2076

    Within first 35 days

Secondary Outcomes (2)

  • Correlative studies of activity

    throughout the study period

  • Clinical Benefit

    Each cycle of treatment

Study Arms (1)

ENMD-2076

EXPERIMENTAL

Oral capsules, once daily in 28-day cycles

Drug: ENMD-2076

Interventions

ENMD-2076DRUG
ENMD-2076

Eligibility Criteria

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

You may qualify if:

  • Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
  • Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
  • Age ≥18 years.
  • ECOG performance status 0-2.
  • Patients must have adequate organ and marrow function

You may not qualify if:

  • Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
  • Prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis).
  • Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
  • Have unstable angina pectoris or recent myocardial infarction (within 6 months.
  • Have uncontrolled hypertension or congestive heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ENMD 2076

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 10, 2008

Study Start

December 1, 2008

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)