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

This study has been completed.
Sponsor:
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00422786
First received: January 12, 2007
Last updated: July 10, 2008
Last verified: July 2008
History of Changes
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
 Drug: CAP-232
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Thallion Pharmaceuticals:

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)

Enrollment: 10
Study Start Date: March 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: TLN-232

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422786

Locations
France
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, France, 34298
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
  More Information

Publications:

Responsible Party: Didier Reymond, MD / Vice-President Medical and Clinical Affairs, Thallion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00422786     History of Changes
Other Study ID Numbers: CTP_CAP001
Study First Received: January 12, 2007
Last Updated: July 10, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Thallion Pharmaceuticals:
Refractory Clear Cell Renal Cell Carcinoma
Phase II
Thallion
 TLN-232
CAP-232
M2PK

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013