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:
Boehringer Ingelheim Pharmaceuticals
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
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Purpose
Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: Trastuzumab Drug: BIBW 2992 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Label Phase I Combination Trial of BIBW 2992 and Herceptin in Patients With Refractory Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Trastuzumab
Load: 4mg/kg-maintain:2mg/kg/week
Drug: BIBW 2992
Increased dose cohorts from low dose to MTD
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Female patients aged >18 years.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950742
Locations
| United Kingdom | |
| 1200.68.44001 Boehringer Ingelheim Investigational Site | |
| Brighton, United Kingdom | |
| 1200.68.44003 Boehringer Ingelheim Investigational Site | |
| Cambridge, United Kingdom | |
| 1200.68.44005 Boehringer Ingelheim Investigational Site | |
| Guildford, United Kingdom | |
| 1200.68.44004 Boehringer Ingelheim Investigational Site | |
| Newcastle upon Tyne, United Kingdom | |
| 1200.68.44002 Boehringer Ingelheim Investigational Site | |
| Truro, United Kingdom | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00950742 History of Changes |
| Other Study ID Numbers: | 1200.68, 2009-010003-89 |
| Study First Received: | July 31, 2009 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013