NCT00405743

Brief Summary

Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing

Trial Health

93
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Longer than P75 for phase_1

Geographic Reach
6 countries

16 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

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 18, 2013

Status Verified

September 1, 2013

Enrollment Period

3 years

First QC Date

November 29, 2006

Last Update Submit

September 12, 2013

Conditions

Hematologic MalignanciesAML

Keywords

CP-4055ELACYT™CancerRefractoryRelapsedHematologic MalignanciesLeukemiaALLAMLAMMCLLCMLCMMLMDS

Outcome Measures

Primary Outcomes (2)

  • Phase I: Determine the MTD and PK properties of CP-4055 single agent.

    Q4 2007

  • Phase II: Determine the efficacy of CP-4055 single agent in AML

    Q4 2007

Secondary Outcomes (3)

  • Phase I: Evaluate the safety profile of CP-4055 single agent.

    Q4 2007

  • Determine the MTD and PK of CP-4055 in combination with idarubicin.

    Q2 2008

  • Phase II: Extended evaluation of the safety profile of CP-4055 single agent in AML

    Q2 2008

Study Arms (2)

Arm A

EXPERIMENTAL

CP4055, 2 and 4 hour IV infusion

Drug: CP-4055

Arm B

EXPERIMENTAL

CP-4055, Continuous IV infusion

Drug: CP-4055

Interventions

CP-4055DRUG

CP-4055 Continuous IV infusion

Arm B

Eligibility Criteria

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

You may qualify if:

  • ARM A and B: Phase I CP-4055 single agent 1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
  • ARM C: CP-4055 in combination with idarubicin
  • Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
  • ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
  • Patients must be 18 years of age or older
  • Patients must have ECOG performance status (PS) of 0 - 2. See Appendix 3
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
  • Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
  • Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
  • In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
  • Patients must have the following clinical laboratory values:
  • Serum creatinine less or equal to 1.5 x the institutional upper limit of normal (ULN)
  • Total bilirubin less or equal to 1.5 x the ULN unless considered due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) less or equal to 2.5 x the ULN unless considered due to organ leukemic involvement
  • Phase II
  • +1 more criteria

You may not qualify if:

  • Phase I AND II
  • A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
  • Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
  • Pregnant and nursing patients are excluded
  • Uncontrolled intercurrent illness
  • Active heart disease
  • Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
  • Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
  • Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Mew York Medical College, Division of Oncology

Valhalla, New York, 10595, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.

San Antonio, Texas, 78229, United States

Location

Hematology Service, Hôpital Beaujon and Hôpital Avicenne

Bobigny, Paris, 93009, France

Location

Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique

Lyon, 69437, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan

Toulouse, 40031-31059, France

Location

University Hospital Benjamin Franklin Med.Clinic III

Berlin, 12200, Germany

Location

Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II

Frankfurt am Main, 60590, Germany

Location

Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A

Münster, 48129, Germany

Location

Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna

Bologna, 40138, Italy

Location

Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata

Rome, 00133, Italy

Location

Department of Hematology, Ullevål University Hospital, University of Oslo

Oslo, 0407, Norway

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Hematologic NeoplasmsNeoplasmsRecurrenceLeukemia

Interventions

5'-oleoyl cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Histologic Type

Study Officials

  • Francis J Giles, MD

    Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2006

First Posted

November 30, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

September 18, 2013

Record last verified: 2013-09

Locations

NO(1)IT(2)DE(3)FR(4)US(5)GB(1)