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

July 10, 2008 updated by: Thallion Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle Paul-Lamarque
      • St-Priest en Jarez, France, 42270
        • Institut de Cancérologie de la Loire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy parameter was the response rate based on RECIST criteria after 3 cycles

Secondary Outcome Measures

Outcome Measure
Quality of life
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
Biological modulation (through potential blood and/or urine biomarkers including M2PK)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

January 12, 2007

First Submitted That Met QC Criteria

January 12, 2007

First Posted (Estimate)

January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

July 15, 2008

Last Update Submitted That Met QC Criteria

July 10, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP_CAP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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