Last updated: 11/04/2018 06:33:44
GW572016 For Treatment Of Refractory Metastatic Breast Cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens
Trial description: This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW572016
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
November 2003 to February 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
Inclusion and exclusion criteria
Inclusion criteria:
- Signed Informed Consent.
- Histologically confirmed Stage IIIb or IV breast cancer.
- Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
- Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
- Documented disease progression of the most recent treatment is required.
- Archived tumor tissue available for testing.
- Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
- At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
- Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
- Able to swallow and retain oral medication.
- Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
- Adequate kidney and liver function.
- Adequate bone marrow function.
Exclusion criteria:
- Pregnant or lactating.
- Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
- Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
- History of other malignancy.
- Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
- Active or uncontrolled infection.
- Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
- Known history of or clinical evidence of leptomeningeal carcinomatosis.
- Active infection.
- Concurrent cancer therapy or investigational therapy.
- Use of oral or IV steroids.
- Unresolved or unstable serious toxicity from prior therapy.
- Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.
Trial location(s)
Location
GSK Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1455BWU
Status
Will Be Recruiting
Location
GSK Investigational Site
Bebington, Wirral, United Kingdom, CH63 4JY
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-02-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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