A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clavis Pharma
ClinicalTrials.gov Identifier:
NCT00405743
First received: November 29, 2006
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Hematologic Malignancies
AML
Drug: CP-4055
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Clavis Pharma:

Primary Outcome Measures:
  • Phase I: Determine the MTD and PK properties of CP-4055 single agent. [ Time Frame: Q4 2007 ] [ Designated as safety issue: Yes ]
  • Phase II: Determine the efficacy of CP-4055 single agent in AML [ Time Frame: Q4 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I: Evaluate the safety profile of CP-4055 single agent. [ Time Frame: Q4 2007 ] [ Designated as safety issue: Yes ]
  • Determine the MTD and PK of CP-4055 in combination with idarubicin. [ Time Frame: Q2 2008 ] [ Designated as safety issue: Yes ]
  • Phase II: Extended evaluation of the safety profile of CP-4055 single agent in AML [ Time Frame: Q2 2008 ] [ Designated as safety issue: Yes ]

Enrollment: 153
Study Start Date: May 2006
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
CP4055, 2 and 4 hour IV infusion
Drug: CP-4055
CP4055 2 and 4 hour IV infusion
Experimental: Arm B
CP-4055, Continuous IV infusion
Drug: CP-4055
CP-4055 Continuous IV infusion

Detailed Description:

This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy.

In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed.

It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  1. 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

  2. Patients must be 18 years of age or older
  3. Patients must have ECOG performance status (PS) of 0 - 2. See Appendix 3
  4. 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

  5. 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
  6. 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.
  7. 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. Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy

2 - 7. Identical to inclusion criteria nos. 2 - 7 for phase I

Exclusion Criteria:

Phase I AND II

  1. 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
  2. Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
  3. Pregnant and nursing patients are excluded
  4. Uncontrolled intercurrent illness
  5. Active heart disease
  6. 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
  7. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

    Exclusion criteria no. 8 applies only in arm C:

  8. Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405743

Locations
United States, New York
Mew York Medical College, Division of Oncology
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center (DUMC)
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.
San Antonio, Texas, United States, 78229
France
Hematology Service, Hôpital Beaujon and Hôpital Avicenne
Bobigny, Paris, France, 93009
Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique
Lyon, France, 69437
Institut Paoli-Calmettes
Marseille, France, 13273
Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan
Toulouse, France, 40031-31059
Germany
University Hospital Benjamin Franklin Med.Clinic III
Berlin, Germany, 12200
Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II
Frankfurt am Main, Germany, 60590
Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A
Münster, Germany, 48129
Italy
Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna
Bologna, Italy, 40138
Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata
Rome, Italy, 00133
Norway
Department of Hematology, Ullevål University Hospital, University of Oslo
Oslo, Norway, 0407
United Kingdom
Christie Hospital
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Clavis Pharma
Investigators
Principal Investigator: Francis J Giles, MD Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA
  More Information

No publications provided

Responsible Party: Clavis Pharma
ClinicalTrials.gov Identifier: NCT00405743     History of Changes
Other Study ID Numbers: CP4055-106
Study First Received: November 29, 2006
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Clavis Pharma:
CP-4055
ELACYT™
Cancer
Refractory
Relapsed
Hematologic Malignancies
Leukemia
ALL
AML
AMM
CLL
CML
CMML
MDS

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014