CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
lapatinib ditosylatedrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed endometrial carcinoma that is recurrent or persistent
  • ✓Refractory to curative therapy or standard treatments
  • ✓Measurable disease: at least 1 unidimensionally measurable lesion ≥20 mm by conventional techniques or ≥10 mm by spiral CT scan
  • ✓Must have received 1 prior chemotherapy regimen for endometrial carcinoma, with no more than 1 additional prior cytotoxic regimen for recurrent or persistent disease
Key exclusion· 8
  • ✕Prior trastuzumab or any target-specific therapy directed to the HER family (e.g., gefitinib, erlotinib, or cetuximab)
  • ✕Prior non-cytotoxic chemotherapy for recurrent or persistent disease
  • ✕Prior lapatinib
  • ✕Gastrointestinal tract disease resulting in inability to take oral medication, malabsorption syndrome, or requirement for IV alimentation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00096447
NCT00096447Phase 2Completed
CompareCT.gov

A Phase II Evaluation Of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

National Cancer Institute (NCI)·interventional·Posted Nov 10, 2004·Updated Jul 24, 2019

In Brief

A Phase 2 clinical trial evaluating lapatinib ditosylate for Recurrent Endometrial Carcinoma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Endometrial Carcinoma
CountriesUnited States
CollaboratorsGynecologic Oncology Group

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2004
Enrollment StartNov 1, 2004
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 21.6 years ago

Interventions

lapatinib ditosylatedrug