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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-000868-83-GB
• Date of registration: 28/12/2007
• Prospective Registration: Yes
• Primary sponsor: Clavis Pharma ASA
• Public title: A Phase I/II Study of CP-4055 in Patients with Refractory/Relapsed Hematologic Malignancies
• Scientific title: A Phase I/II Study of CP-4055 in Patients with Refractory/Relapsed Hematologic Malignancies
• Date of first enrolment: 30/04/2008
• Target sample size: 200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000868-83
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Phase II
1. Patients with a confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukemia) who have received at least two previous regimens of chemotherapy and
A. have never achieved CR or CRp, or
B. have relapsed after a CR1 or CRp and failed to respond to a cytotoxic first salvage therapy, or have relapsed after = 6 months from a CR2 or CRp
2. Patients must be 18 years of age or older
3. Patients must have ECOG performance status (PS) of 0 – 2.
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
If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 24 hours before initiation of treatment on this protocol. Persistent chronic clinically significant toxicities from prior chemotherapy must not be greater than Grade 1
7. Patients must have the following clinical laboratory values:
• Serum creatinine = 1.5 x the institutional upper limit of normal (ULN)
• Total bilirubin = 1.5 x the ULN unless considered due to Gilbert’s syndrome
• Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) = 2.5 x the ULN unless considered due to organ leukemic involvement.
8. Patient’s bone marrow aspirates and/or biopsies must contain > 5 % blasts or patient must have biopsy-proven extramedullary AML, or patient’s peripheral blood shows occurrence of leukemic blasts
9. Previous bone marrow and/or stem cell transplantation must be completed a minimum of 3 months prior to inclusion in the study. Allogenic transplanted patients must be off immunosuppressive treatment for a minimum of 4 weeks. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation in CR1 or CR2 or CRp.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. A history of allergic reactions to egg
A history of allergic reactions of CTCAE grade 3 or 4 to ara-C
2. Known CNS leukemia
3. Another known active cancer within the last 5 years
4. Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
5. Pregnant and nursing patients are excluded because the effects of CP-4055 on a fetus or nursing child are unknown
6. Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
7. Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4.
8. Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy
9. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Phase II. Acute Myeloid Leukemia (AML)
MedDRA version: 9.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia

Intervention(s)

Product Name: ara-C-elaidate
Product Code: CP-4055, previously called P-4055
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ara-C-elaidate
CAS Number: 188181-42-2
Current Sponsor code: CP-4055
Other descriptive name: 5'-O-(trans-9''-octadecenoyl) 1-beta-D arabinofuranosyl cytosine
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): Phase II
Efficacy Endpoints: Incidence of CR, including complete response but platelet count <100 x 10^9/L (CRp), following 1 or 2 courses of therapy, and the 6 month survival rate.

Secondary Objective: Phase II: Characterize the safety profile of CP-4055 in these patients

Main Objective: Phase II : Determine the efficacy of single agent CP-4055 in patients receiving second salvage therapy for AML

Secondary ID(s)

CP4055-106