At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
lapatinib ditosylate +1 moredrug
Likely dose
lapatinib ditosylate, orally (specific dose not stated in eligibility or arms)AI-extracted
Key inclusion· 8
- ✓Histologically or cytologically confirmed adenoid cystic carcinoma or other malignant salivary gland carcinoma with EGFR and/or erbB2 expression
- ✓Recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy, with progression defined as ≥20% increase in measurable disease, new lesions, or clinical deterioration within 6 months
- ✓Measurable disease ≥20 mm by conventional imaging or ≥10 mm by spiral CT
- ✓Life expectancy >12 weeks
Key exclusion· 9
- ✕Prior treatment with EGFR or erbB2 targeting therapies
- ✕Symptomatic brain metastases
- ✕History of other active malignancy in past 5 years (except cervical carcinoma in situ or non-melanomatous skin cancers)
- ✕Allergic reactions to compounds of similar chemical or biologic composition to GW572016
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of GW572016 in Recurrent and/or Metastatic Adenoid Cystic Carcinoma, and Other EGFR-and/or erbB2-expressing Malignant Tumors of the Salivary Glands
In Brief
A Phase 2 clinical trial evaluating lapatinib ditosylate and laboratory biomarker analysis for High-grade Salivary Gland Carcinoma and 9 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh-grade Salivary Gland Carcinoma, High-grade Salivary Gland Mucoepidermoid Carcinoma, Low-grade Salivary Gland Carcinoma, Low-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Adenoid Cystic Carcinoma, Salivary Gland Malignant Mixed Cell Type Tumor
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedNov 2004
Primary CompletionFeb 2009
Study CompletionJun 2009
TodayJul 2026
First PostedNov 8, 2004
Enrollment StartSep 1, 2004
Primary CompletionFeb 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 21.7 years ago
Interventions
lapatinib ditosylatedrug
Given orally
laboratory biomarker analysisother
Correlative studies