CNTO328STM2001

• Research type

  Research Study

• Full title

  A Phase 1/2, Multiple-dose, Dose-escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects with Solid Tumors

• IRAS ID

  20221

• Contact name

  Christian Ottensmeier

• Eudract number

  2008-0051180-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The goal of this study is to evaluate the safety and efficacy profile of CNTO328 in subjects with selected solid tumours that have progressed on or after standard therapy, or for which there is no effective therapy. The study consists of two parts. Part 1, groups of patients are treated with different dose levels. Part 2, the selected dose and schedule will be further explored in patients with specific tumour types. CNTO328 is given by intravenous (IV) infusion; over 1 hour. In Part 1,cohorts 1-4, patients will receive different doses (2.8-15 mg/kg) and will be evaluated for the occurrence of toxicities. In cohort 5 up to 20 patients with ovarian cancer or KRAS mutant tumours will be treated with the chosen dose, based on the experience in cohorts 1-4. The purpose of Part 1 is to determine the recommended dose of CNTO328. In Part 2, patients will receive the recommended dose and schedule, determined from cohorts 1-5. The main purpose of part 2 is to estimate the clinical benefit of CNTO328 monotherapy in patients with ovarian cancer and with KRAS mutant tumours.To monitor safety, adverse events (AEs) will be reviewed at every visit, and the following assessments performed: physical exam, vital signs, ECGs, blood tests, urine analysis. Assessments are performed weekly during the first 4 weeks of the study and every 2-3 weeks thereafter. Once a patient discontinues study treatment, follow up visits up to 12 weeks after last dose are scheduled. Patients may be contacted for up to one year after the last dose for follow-up survival and disease status information. Patients enrolling in Part 1 (Cohorts 1-4) will receive 4 administrations of CNTO328 over a 10-13 week period, while patients enrolling in Cohort 5 and Part 2 will receive 12 administrations over a 33 week period.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  09/H0502/69

• Date of REC Opinion

  15 Jun 2009

• REC opinion

  Further Information Favourable Opinion