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

NCT ID: NCT00405743

Last Updated: 2013-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-05-31

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

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.

Conditions

Hematologic Malignancies; AML

Keywords

CP-4055; ELACYT™; Cancer; Refractory; Relapsed; Hematologic Malignancies; Leukemia; ALL; AML; AMM; CLL; CML; CMML; MDS

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

CP4055, 2 and 4 hour IV infusion

Group Type: EXPERIMENTAL

CP-4055

Intervention Type: DRUG

CP4055 2 and 4 hour IV infusion

Arm B

CP-4055, Continuous IV infusion

Group Type: EXPERIMENTAL

CP-4055

Intervention Type: DRUG

CP-4055 Continuous IV infusion

Interventions

CP-4055

CP-4055 Continuous IV infusion

Intervention Type: DRUG

CP-4055

CP4055 2 and 4 hour IV infusion

Intervention Type: DRUG

Eligibility 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

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

8. Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clavis Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis J Giles, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Mew York Medical College, Division of Oncology

Valhalla, New York, United States

Duke University Medical Center (DUMC)

Durham, North Carolina, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

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

San Antonio, Texas, United States

Hematology Service, Hôpital Beaujon and Hôpital Avicenne

Bobigny, Paris, France

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

Lyon, , France

Institut Paoli-Calmettes

Marseille, , France

Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan

Toulouse, , France

University Hospital Benjamin Franklin Med.Clinic III

Berlin, , Germany

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

Frankfurt am Main, , Germany

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

Münster, , Germany

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

Bologna, , Italy

Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata

Rome, , Italy

Department of Hematology, Ullevål University Hospital, University of Oslo

Oslo, , Norway

Christie Hospital

Manchester, , United Kingdom

Countries

United States; France; Germany; Italy; Norway; United Kingdom

Other Identifiers

CP4055-106

Identifier Type: -

Identifier Source: org_study_id