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

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405743
• Other study ID #: CP4055-106
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 29, 2006
• Last updated: September 12, 2013
• Start date: May 2006
• Est. completion date: May 2010

Study information

• Verified date: September 2013
• Source: Clavis Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• CP-4055
CP-4055 Continuous IV infusion
• CP-4055
CP4055 2 and 4 hour IV infusion

Locations

Country	Name	City	State
France	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
Germany	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
Italy	Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna	Bologna
Italy	Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata	Rome
Norway	Department of Hematology, Ullevål University Hospital, University of Oslo	Oslo
United Kingdom	Christie Hospital	Manchester
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Duke University Medical Center (DUMC)	Durham	North Carolina
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	Mew York Medical College, Division of Oncology	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Clavis Pharma

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Determine the MTD and PK properties of CP-4055 single agent.		Q4 2007	Yes
Primary	Phase II: Determine the efficacy of CP-4055 single agent in AML		Q4 2007	No
Secondary	Phase I: Evaluate the safety profile of CP-4055 single agent.		Q4 2007	Yes
Secondary	Determine the MTD and PK of CP-4055 in combination with idarubicin.		Q2 2008	Yes
Secondary	Phase II: Extended evaluation of the safety profile of CP-4055 single agent in AML		Q2 2008	Yes