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

Carcinoma, Renal Cell Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422786
• Other study ID #: CTP_CAP001
• Status: Completed
• Phase: Phase 2
• First received: January 12, 2007
• Last updated: July 10, 2008
• Start date: March 2007
• Est. completion date: March 2008

Study information

• Verified date: July 2008
• Source: Thallion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• CAP-232
Continuous IV infusion over 21 days at 0.48 mg/kg/day followed by a 7-day rest period

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle Paul-Lamarque	Montpellier
France	Institut de Cancérologie de la Loire	St-Priest en Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Thallion Pharmaceuticals

Country where clinical trial is conducted

France, 

References & Publications (3)

Gyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151

Tejeda M, Gaál D, Hullán L, Csuka O, Schwab R, Szokoloczi O, Kéri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5. — View Citation

Tejeda M, Gaál D, Hullán L, Hegymegi-Barakonyi B, Kéri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles
Secondary	Safety (through clinical and biological evaluations)
Secondary	Other efficacy parameters (progression-free survival rate, time to progression and overall survival)
Secondary	Pharmacokinetic (PK) characteristics of the first 15 recruited patients
Secondary	Quality of life
Secondary	Biological modulation (through potential blood and/or urine biomarkers including M2PK)