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Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00950742
First received: July 31, 2009
Last updated: January 9, 2013
Last verified: January 2013
History of Changes

July 31, 2009
January 9, 2013
August 2009
May 2013   (final data collection date for primary outcome measure)
The primary endpoint of this study will be the Maximum Tolerated Dose of BIBW 2992 given in combination with Herceptin®. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary endpoint of this study will be the Maximum Tolerated Dose of BIBW 2992 given in combination with Herceptin®. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00950742 on ClinicalTrials.gov Archive Site
  • Incidence and intensity of AEs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • PK parameters of BIBW 2992 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Objective tumour responses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall response rates and Progression Free Survival (PFS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events (AEs). [ Time Frame: 6 months ]
  • Pharmacokinetic (PK) parameters of BIBW 2992. [ Time Frame: 6 months ]
  • Objective tumour responses. [ Time Frame: 6 months ]
  • Overall response rates. [ Time Frame: 6 months ]
  • Progression Free Survival (PFS). [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Open Label Phase I Combination Trial of BIBW 2992 and Herceptin in Patients With Refractory Breast Cancer

Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Trastuzumab
    Load: 4mg/kg-maintain:2mg/kg/week
  • Drug: BIBW 2992
    Increased dose cohorts from low dose to MTD
Experimental: BIBW 2992 + Trastuzumab
Find maximum tolerated dose of the non-marketed substance:BIBW 2992 given orally with fixed weekly infusion doses of 2mg/kg Herceptin. Escalating doses of BIBW 2992 starting at 20mg daily.
Interventions:
  • Drug: Trastuzumab
  • Drug: BIBW 2992
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Female patients aged >18 years.
  2. Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+ or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib® (in the adjuvant or metastatic settings) is permitted but not required.

Exclusion criteria:

Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before the start of therapy or concomitantly with this study.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00950742
1200.68, 2009-010003-89
Not Provided
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
January 2013

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