Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma

This was a multi-center, open label, single arm study. Approximately 40 patients were initially planned to be recruited.

Each patient was to receive a treatment cycle consisting of CAP-232 via continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period. Treatment cycles to be repeated in the absence of disease progression or unacceptable toxicity.

Quality of Life questionnaires were to be administered at baseline, after each visit and at the end of the study.

Signs and symptoms of adverse events were closely monitored during treatment cycles. Safety laboratory measures were done at Screening, during the 72hr hospitalization (first cycle), at every interim visit , and at the end of the study. A follow-up safety visit was to be scheduled at least 30 days after the end of treatment.

CAP-232 plasma levels were also determined.

Inclusion criteria

• Histologically confirmed stage IV kidney clear cell carcinoma.
• Confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
• Measurable disease
• Age >18 years.
• Life expectancy of greater than 3 months.
• At least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
• ECOG performance status 2 or lower (Karnofsky 60%).
• Normal organ and marrow function
• Adequate contraception prior to study entry and for the duration of study participation.
• Ability to understand and have the willingness to sign a written informed consent document.
• Ability to receive central vein access catheter and manage an infusion pump.
• Women of child bearing potential must have a negative serum pregnancy test.

Exclusion criteria

• Anti-cancer therapy within 4 weeks prior to entering the study
• Investigational agents less than 30 days prior to enrollment in the study.
• Known brain metastases
• History of allergic reactions attributed to compounds of similar composition to CAP-232.
• Past or current cancer other than kidney cancer, except for: Curatively treated non-melanoma skin cancer, In situ carcinoma of the cervix, Other cancer curatively treated and with no evidence of disease for at least 5 years
• Uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
• Breastfeeding
• Patients previously enrolled into this study and subsequently withdrawn