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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Aline Guillot, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut de Cancérologie de la Loire, Dpt Oncologie Médicale, Saint-Priest en Jarez, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CTP_CAP001

NCT ID:

NCT00422786

Start Date:

March 2007

Completion Date:

March 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Refractory Clear Cell Renal Cell Carcinoma
  • Phase II
  • Thallion
  • TLN-232
  • CAP-232
  • M2PK
  • Carcinoma
  • Carcinoma, Renal Cell

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