Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study is currently recruiting participants.
Verified March 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01461538
First received: October 24, 2011
Last updated: March 27, 2014
Last verified: March 2014

October 24, 2011
March 27, 2014
October 2011
December 2014   (final data collection date for primary outcome measure)
Objective response rate (ORR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01461538 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 3 weeks after dosing (1.8 and 2.4 mg/kg arms) ] [ Designated as safety issue: No ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Through 1 week after dosing (1.2 mg/kg arm) ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure, up to 29 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: predose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16 hours, and at the end of treatment assessment: predose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lymphoid Leukemia
  • Acute Myeloid Leukemia
  • Anemia, Refractory, With Excess of Blasts
  • Solid Tumors
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • Drug: brentuximab vedotin
    2.4 mg/kg every 3 weeks by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • Drug: brentuximab vedotin
    1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
    Other Name: Adcetris; SGN-35
  • Experimental: Brentuximab vedotin 1.8 mg/kg
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    Intervention: Drug: brentuximab vedotin
  • Experimental: Brentuximab vedotin 2.4 mg/kg
    Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
    Intervention: Drug: brentuximab vedotin
  • Experimental: Brentuximab vedotin 1.2 mg/kg
    Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
    Intervention: Drug: brentuximab vedotin
Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Farè E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
April 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease
Both
6 Years and older
No
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com
United States
 
NCT01461538
SGN35-013
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP