A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML)

NCT01090167 | Completed Phase 1 DMC

• 1 other identifier: CLOAML10508
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 6

Brief Summary

This study is sponsored by Genzyme Japan K.K. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Clofarabine (JC0707) intravenously administered to Japanese adult patients with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) at 20, 30, and 40 mg/m2/day on a 5-day dose schedule.

Conditions

Acute Myelogenous Leukemia

Outcome Measures

Primary Outcomes (13)

• Maximum Tolerated Dose (MTD) as determined by Dose Limiting Toxicities (DLTs)

  28 days (1st cycle)

• Safety as measured by number of patients with at least one adverse events (incidence)

  50 days

• Safety as measured by severity of adverse events

  50 days

• Safety as measured by duration of adverse events

  50 days

• Safety as measured by causality of adverse events

  50 days

• Safety as measured by seriousness of adverse events

  50 days

• Safety as measured by type of adverse event

  50 days

• Safety as measured by number of deaths

  50 days

• Safety as measured by number of serious adverse events

  50 days

• Safety as measured by number of patients who discontinue due to adverse events

  50 days

• Safety as measured by clinically significant changes in hematology

  50 days

• Safety as measured by clinically significant changes in chemistry parameters (i.e. serum chemistry)

  50 days

• Pharmacokinetic (PK) parameters (Cmax, Tmax, AUC)

  6 days

Study Arms (1)

Clofarabine

EXPERIMENTAL

Drug: clofarabine

Interventions

clofarabine DRUG

Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2

Also known as: Evoltra, Clolar, JC0707

Clofarabine

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having diagnosis of relapsed or refractory Acute Myeloid Leukemia (AML) according to the World Health Organization (WHO) criteria or untreated AML patients (60 years to 74 years) for whom standard induction chemotherapy is unlikely to be of benefit as judged by the investigator (or co-investigator)
• Age at the time of informed consent 20 years up to 74 years; 60 years or older for patients with previously untreated AML
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
• Be able to comply with the study procedures and follow-up examinations specified in this protocol.
• Hepatic, renal, pancreatic, and cardiac function satisfying the laboratory values criteria

You may not qualify if:

• Patients having diagnosis of acute promyelocytic leukemia(APL, French-American-British classification M3 or WHO classification of APL with t(15;17)(q22;q12), (PML/RARA and variants)
• Have had prior hematologic stem cell transplant
• Have had prior external beam radiation therapy to the pelvis
• Have systemic fungal, bacterial, viral, or other infection that cannot be controlled and is exhibiting symptoms related to the infection despite appropriate treatment. In addition, patients must have a temperature less than 38.0 for at least 48 hours prior to the first dose of the study drug.
• Have any other severe concurrent disease that is difficult to control by drug therapies, or have a history of serious organ dysfunction or disease involving the liver, kidney, pancreas, heart, or other organ system that may place the patient at undue risk
• Diagnosis of another malignancy, unless the patient meets none of the following conditions: 1) Any persisting treatment-related adverse events; 2) Less than 180 days of disease-free duration counted during the period from the treatment completion to enrollment; note that the patients meeting any of the following conditions is eligible:
• Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia are eligible for this study if treatment for the condition has been completed.
• Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
• Have a prior positive test for HBs antigen or antibody, HBc antibody, HCV antibody, or HIV antigen or antibody; note that the patients who have had treatment of vaccine and positive for HBs antibody is eligible.
• Have a clinically significant arrhythmia at screening or a known family history of QT prolongation. Marked prolongation of QTc interval exceeding 450 msec is considered clinically significant
• Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia
• Have a Psychiatric disorders that would interfere with consent, study participation, or follow-up
• Have had prior treatment with the study drug
• Have had any other chemotherapy or investigational agent received within 30 days prior to the first dose of the study drug
• If received any chemotherapy or investigational agent prior to this time point, drug-related adverse events must be recovered to the baseline value or Grade 1 or less prior to the first dose of the study drug (except for alopecia, and nail changes).

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (6)

Nagoya Daini Red Cross Hospital

Aichi, Japan

Location

National Hospital Organization Nagoya Medical Center

Aichi, Japan

Location

University of Fukui Hospital

Fukui, Japan

Location

Tokai University Hospital

Kanagawa, Japan

Location

Jichi Medical University Hospital

Tochigi, Japan

Location

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Clofarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 19, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 19, 2014

Record last verified: 2014-03

Locations

JP (6)