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An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors.

Publication ,  Journal Article
Stephenson, JJ; Gregory, C; Burris, H; Larson, T; Verma, U; Cohn, A; Crawford, J; Cohen, RB; Martin, J; Lum, P; Yang, X; Amado, RG
Published in: Clin Colorectal Cancer
January 2009

PURPOSE: This study evaluated safety, pharmacokinetics, and efficacy of 2 dose schedules and 2 infusion times of panitumumab in patients with advanced solid malignancies. PATIENTS AND METHODS: This phase I multicenter, open-label study sequentially enrolled patients with advanced solid tumors refractory to standard therapy, or for which no standard therapy exists, to receive panitumumab 6 mg/kg every 2 weeks or 9 mg/kg every 3 weeks. Patients receiving panitumumab every 2 weeks received either all infusions over 60 minutes or a 60-minute infusion for the first dose followed by 30-minute infusions if the first infusion was well tolerated. Patients in the every-3-week cohort received 60-minute infusions. Safety outcomes included the incidence of adverse events and antipanitumumab antibody formation. Pharmacokinetic properties were determined. Efficacy endpoints included response rate and duration of response. RESULTS: Eighty-six patients were enrolled; 84 (98%) received panitumumab. Treatment-related adverse events occurred in 90% of patients. Safety profiles were similar between patients receiving 30-minute (n = 20) and 60-minute (n = 43) infusions every 2 weeks and patients receiving panitumumab every 3 weeks (n = 21). Panitumumab exposure at steady state increased dose proportionally, and peak serum concentrations were similar in patients receiving either 30- or 60-minute infusions every 2 weeks. Objective responses were seen in 4 patients (5%) with colon, rectal, esophageal, and bladder cancers. CONCLUSION: Similar drug exposures and safety profiles were observed in patients receiving panitumumab 6 mg/kg every 2 weeks with either 30- or 60-minute infusions and antitumor activity was seen in some patients. Exposure increased approximately dose proportionally at steady state.

Duke Scholars

Published In

Clin Colorectal Cancer

DOI

ISSN

1533-0028

Publication Date

January 2009

Volume

8

Issue

1

Start / End Page

29 / 37

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Panitumumab
  • Oncology & Carcinogenesis
  • Neoplasms
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Female
  • Endpoint Determination
 

Citation

APA
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ICMJE
MLA
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Stephenson, J. J., Gregory, C., Burris, H., Larson, T., Verma, U., Cohn, A., … Amado, R. G. (2009). An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clin Colorectal Cancer, 8(1), 29–37. https://doi.org/10.3816/CCC.2009.n.005
Stephenson, Joe J., Charles Gregory, Howard Burris, Tim Larson, Udit Verma, Allen Cohn, Jeffrey Crawford, et al. “An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors.Clin Colorectal Cancer 8, no. 1 (January 2009): 29–37. https://doi.org/10.3816/CCC.2009.n.005.
Stephenson JJ, Gregory C, Burris H, Larson T, Verma U, Cohn A, et al. An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clin Colorectal Cancer. 2009 Jan;8(1):29–37.
Stephenson, Joe J., et al. “An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors.Clin Colorectal Cancer, vol. 8, no. 1, Jan. 2009, pp. 29–37. Pubmed, doi:10.3816/CCC.2009.n.005.
Stephenson JJ, Gregory C, Burris H, Larson T, Verma U, Cohn A, Crawford J, Cohen RB, Martin J, Lum P, Yang X, Amado RG. An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clin Colorectal Cancer. 2009 Jan;8(1):29–37.
Journal cover image

Published In

Clin Colorectal Cancer

DOI

ISSN

1533-0028

Publication Date

January 2009

Volume

8

Issue

1

Start / End Page

29 / 37

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Panitumumab
  • Oncology & Carcinogenesis
  • Neoplasms
  • Middle Aged
  • Male
  • Infusions, Intravenous
  • Humans
  • Female
  • Endpoint Determination