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Prophylactic Octreotide in Lapatinib/Capecitabine-treated Breast Cancer
NCT02294786Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2014
- Primary completion
- Oct 2017
- Countries
- 5
- Sponsor
- Novartis
- Modality
- Peptides
- Conditions
- diarrhea
01
Overview
Phase 2, randomised, open-label trial of Octreotide long-acting injection in diarrhea (2 arms), sponsored by Novartis. Primary endpoint: Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above at 24 weeks. Started Dec 2014; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Octreotide treatment
Octreotide prophylaxis + Lapatinib + Capecitabine
No Octreotide treatment
Lapatinib + Capecitabine
03
Who it enrols
Adult females with HER2-positive metastatic breast cancer progressed after prior therapy including anthracyclines, taxanes, and trastuzumab. Patients with recent diarrhea or significant GI disorders are excluded.
04
Endpoints
Primary
Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above
Secondary
Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above
Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity
Duration of Diarrhoea of Any Grade of Severity
Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity
Proportion of Subjects Taking Anti-diarrhoeal Medication
Proportion of Subjects Who Had Unscheduled Visits to Healthcare Professionals Due to Diarrhoea
Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine
Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine
05
Results
Not all primary endpoints met
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