NCT00423410

Brief Summary

This study will evaluate the safety, pharmacokinetics (PK), and pharmacodynamic effects of a novel anti-cancer drug, EPC2407, administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies

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

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

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, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

January 16, 2007

Last Update Submit

September 9, 2009

Conditions

Advanced Cancer

Keywords

CancerTumorLymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety

    Duration of drug exposure

Study Arms (1)

EPC2407 (crinobulin)

EXPERIMENTAL
Drug: EPC2407 (crinobulin)

Interventions

EPC2407 (crinobulin)DRUG

IV infusion 1 to 4 hours

EPC2407 (crinobulin)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed solid tumor or lymphoma,which has progressed on standard therapies, for which effective therapy is not available or for patients who are unwilling to undergo such therapies.
  • Males and Females at least 18 years of age
  • Laboratory data as specified below (according to the site's clinical laboratory ranges for normal):
  • i. Hematology: ANC \>1500 cells/mm3, platelet count \>100,000 cells/mm3 and Hemoglobin \> 9 gm/L ii. Hepatic: Direct bilirubin \<1.5 X ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 X ULN. For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5.0 X ULN iii. Renal: serum creatinine WNL or creatinine clearance \>60 mL/min
  • lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec for women.
  • Estimated life expectancy of at least 3 months
  • ECOG Performance Status \< or = 1
  • Previously treated CNS disease allowed if treatment completed and stable for 4 weeks.
  • For men and women of child-producing potential - willingness to employ appropriate contraceptive methods (including abstinence) during the study
  • Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments
  • Cardiac ejection fraction ≥50% by 2D Echocardiogram or \> institutional lower limits of normal

You may not qualify if:

  • Women who are pregnant or nursing
  • Major surgery within the last 4 weeks or minor surgery within the last 2 weeks
  • Anthracycline exposure exceeding a cumulative dose of 360 mg/m²
  • Known and ongoing HIV, Hepatitis B or Hepatitis C infection
  • Concomitant use of strong inhibitors of the liver microsomal enzymes CYP2C8, CYP2C9, CYP2C19 and CYP3A4.
  • Participation in concurrent study of an investigational agent or device
  • Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible
  • O2 Saturation by pulse oximetry at rest \< 90%
  • Concomitant use of drugs that have significant risk of Torsades de Pointes will also be prohibited. Please refer to drugs listed under "Drugs with Risk of Torsades de Pointes"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Tower Oncology Research

Beverly Hills, California, 90211, United States

Location

Rebecca and John Moores UCSD Cancer Center

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

NeoplasmsLymphoma

Interventions

crolibulin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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

January 16, 2007

First Posted

January 18, 2007

Study Start

December 1, 2006

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

US(3)