Amonafide Dihydrochloride (Quinamed®)

CGX-571-SOCA-101 is a phase 1/2a open-label study to evaluate the efficacy and safety of intravenous administration of amonafide dihydrochloride (Quinamed®) in the treatment of patients with prostate, breast and ovarian cancer refractory to current therapies. This trial seeks to confirm potential for dosing based on prospective genotyping, using patients' NAT2 genetope status as the basis for dosing stratification.

Approximately 30 patients will be enrolled in the study being conducted at Tennessee Oncology in Nashville, TN, U.S.A.

Who can participate?

Selected inclusion criteria:

• Patients will have hormone refractory cancer after treatment failure with approved or experimental therapies;
• Age 18 years of age, of either sex;
• Performance status of 0 - 2 ECOG scale (60% Karnofsky scale);
• Life expectancy greater than 4 weeks;
• Patients must have been off previous anticancer therapy for at least 3 weeks (4 weeks from any type of investigational therapy, 6 weeks for prior nitrosourea or mitomycin C) and have recovered fully from the toxic effects of that treatment;
• 4 weeks since radiotherapy or surgery;
• Enrollment preference will be given to patients who have measurable disease in at least one dimension by computed tomography (CT) scan, ultrasound, x-ray, caliper measurement of a palpable lesion or other objective measurement, in order to permit an assessment of efficacy, although patients with non-measurable disease will also be considered for enrollment.

Selected exclusion criteria:

• White blood cell count (WBC) < 3,000/mm3, absolute neutrophil count (ANC) < 1,500/mm3, platelets < 100,000/mm3;
• Serum creatinine >1.5 X the upper limit of normal (ULN);
• Total bilirubin > ULN, alkaline phosphatase > 3.0 X ULN (>5 X ULN if known liver metastases); SGOT/AST > 5 X ULN;
• Central nervous system metastases;
• History of stroke or seizure/convulsions;
• Performance Status > 2 ECOG scale (Karnofsky scale < 60%);
• Prior cytotoxic chemotherapy and/or radiation therapy within 3 weeks of entry;
• Prior radiation therapy encompassing > 25% of expected bone marrow distribution;
• Prior treatment with Strontium-89 (Metastron®) or Samarium-153 (Quadramet®);
• New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, cardiac arrhythmia, hypertension or congestive heart failure;
• Myocardial infarction in the previous 12 weeks;
• Active infection, fever;
• Patients who are pregnant or lactating;
• Patients who have participated in any investigational study during the 30 days prior to study drug administration or who are likely to participate in an investigational study during the 30 day period following study drug administration.

Please note there are other additional criteria. The study center will determine if you meet all of the requirements for enrollment. For further information on the CGX-571-SOCA-101 study please contact the ChemGenex clinical trials group at 1-800-877-3009, ext.112 or e-mail us at clinical@chemgenex.com.

Disclosure of Risks

Please note that the safety and effectiveness of this product have not yet been established. As with other anti-cancer treatments, this investigational product may not benefit patients and may cause side effects. These side effects could be severe or even life threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. Patients should discuss these risks with your physician or a study.