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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thallion Pharmaceuticals

Criteria

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• Patients previously enrolled into this study and subsequently withdrawn