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

Sponsor

Thallion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00422786

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: CAP-232	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAP-232 Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.	Drug: CAP-232 Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period Other Names: TLN-232

Arm

Intervention/Treatment

Experimental: CAP-232

Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period.

Drug: CAP-232

Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period

Other Names:

TLN-232

Outcome Measures

Primary Outcome Measures

The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles []

Secondary Outcome Measures

Safety (through clinical and biological evaluations) []
Other efficacy parameters (progression-free survival rate, time to progression and overall survival) []
Pharmacokinetic (PK) characteristics of the first 15 recruited patients []
Quality of life []
Biological modulation (through potential blood and/or urine biomarkers including M2PK) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRLC Val d'Aurelle Paul-Lamarque	Montpellier		France	34298
2	Institut de Cancérologie de la Loire	St-Priest en Jarez		France	42270

Sponsors and Collaborators

Thallion Pharmaceuticals

Investigators

Principal Investigator: Aline Guillot, MD, Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France
Principal Investigator: Damien Pouessel, MD, CRLC Val d'Aurelle Paul-Lamarque, Montpellier, France