Last updated: 11/03/2018 20:17:06
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
A Randomised, Multicentre, Open Label, Phase II Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
GSK study ID
117314
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Randomised, Multicentre, Open Label, Phase II Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Trial description: Diarrhoea is the most commonly reported adverse events (AE) associated with Lapatinib treatment, and is also commonly associated with Capecitabine treatment. Although these events are generally mild to moderate in severity, diarrhoea adversely affects the tolerability of cancer treatment, and in severe cases diarrhoea has the potential to affect the efficacy of treatment due to poor compliance, or treatment interruption or withdrawal. The efficacy of Octreotide in the management of cancer treatment-associated diarrhoea has not been extensively evaluated in large, well-controlled studies. This is a randomised, multi-centre, open-label Phase II study in subjects with Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer which has progressed following prior therapy, which must have included anthracyclines and taxanes and therapy with Trastuzumab in the metastatic setting. This study is not placebo controlled, and there is no active comparator. The study will evaluate whether the prophylactic use of Octreotide Long Acting Release (LAR) offers a clinically meaningful benefit by reducing the frequency and severity of diarrhoea associated with treatment with Lapatinib and Capecitabine. Study completion for a subject will be defined as the completion of 24 weeks of treatment with Lapatinib and Capecitabine, or progression of cancer or the death of the subject during treatment, whichever occurs first. Approximately 140 subjects will be randomized out of which 70 will receive octreotide and 70 will receive no Octreotide
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Proportion of Subjects experiencing diarrhoea of Grade 2 and above
Timeframe: Up to 24 weeks
Secondary outcomes:
Proportion of subjects who had unscheduled visits to healthcare professionals due to diarrhoea
Timeframe: Up to 24 weeks
Proportion of subjects requiring use of diarrhoea-related intravenous fluids
Timeframe: Up to 24 weeks
Proportion of subjects reporting changes in bowel movements from baseline (frequency and/or consistency) as recorded in the Diarrhoea Management Diary (DMD)
Timeframe: Up to 24 weeks
Proportion of subjects requiring dose delay in Lapatinib and Capecitabine
Timeframe: Up to 24 weeks
Proportion of subjects taking anti-diarrhoeal medication as recorded in the DMD
Timeframe: Up to 24 weeks
Proportion of subjects reporting stopping completely or missing doses of anti-cancer tablets due to diarrhoea as recorded in the DMD
Timeframe: Up to 24 weeks
Proportion of subjects making dietary changes due to diarrhoea as recorded in the DMD
Timeframe: Up to 24 weeks
Number of Lapatinib and Capecitabine tablets dispensed and returned
Timeframe: Up to 24 weeks
Proportion of subjects with AEs and SAEs
Timeframe: Up to 24 weeks
Proportion of subjects experiencing diarrhoea of Grade 3 and above
Timeframe: Up to 24 weeks
Proportion of subjects contacting other non-hospital healthcare professionals to discuss diarrhoea as recorded in the DMD
Timeframe: Up to 24 weeks
Duration of diarrhoea of any grade of severity
Timeframe: Up to 24 weeks
Proportion of subjects taking anti-diarrhoeal medication
Timeframe: Up to 24 weeks
Clinical Benefit Response
Timeframe: Up to 24 weeks
Time to the first subject reported change in frequency and/or consistency of bowel movements from baseline as recorded in the DMD
Timeframe: Up to 24 weeks
Proportion of subjects experiencing diarrhoea of any grade of severity
Timeframe: Up to 24 weeks
Proportion of subjects requiring dose reduction in Lapatinib and Capecitabine
Timeframe: Up to 24 weeks
Proportion of subjects requiring treatment withdrawal in Lapatinib and Capecitabine
Timeframe: Up to 24 weeks
Time to onset of the first episode of diarrhoea of any grade of severity
Timeframe: Up to 24 weeks
Overall Response Rate
Timeframe: Up to 24 weeks
Interventions:
Enrollment:
140
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Cancer, Neoplasms
Product
capecitabine, lapatinib, octreotide
Collaborators
None
Study date(s)
December 2014 to September 2016
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
none
- Signed written informed consent
- Histologically or cytologically confirmed HER2-positive advanced or metastatic breast cancer which has progressed following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting
- Concurrent treatment with an investigational agent or concurrent participation in
- another clinical study
Inclusion and exclusion criteria
Inclusion criteria:
- Signed written informed consent
- Histologically or cytologically confirmed HER2-positive advanced or metastatic breast cancer which has progressed following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting
- Females age >=18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Life expectancy of at least 12 weeks
- Able to swallow and retain oral medications
- Incapable of becoming pregnant, or not pregnant and using an adequate form of contraception, i.e. a female who is of: a. non-childbearing potential (physiologically incapable of becoming pregnant), including any female who has had hysterectomy, bilateral oophorectomy, bilateral tubular ligation or is post-menopausal (total cessation of menses for at least 1 year); b. childbearing potential must have a negative serum pregnancy test within 7 days prior to treatment with Octreotide if randomised to receive Octreotide or the first dose of Lapatinib with Capecitabine if randomised to receive no Octreotide, preferably as close to the first dose as possible, and must agree to use adequate contraception (intrauterine device, birth control pills unless clinically contraindicated, or barrier device) and other acceptable contraceptive methods during the study and continuing for at least 4 weeks after the final dose of treatment with Lapatinib and Capecitabine
- Subjects must complete all screening assessments as outlined in the protocol
- Subjects must complete the Functional Assessment of Chronic Illness Therapy-Diarrhoea (FACIT-D) and diarrhoea diary before receiving the first dose of Octreotide if randomised to receive Octreotide. All subjects must complete the FACIT-D and diarrhoea diary before receiving the first dose of Lapatinib with Capecitabine
- Prior treatment with other chemotherapeutic agents or endocrine therapy is permitted. All prior treatment related toxicities, except diarrhoea and alopecia, must be National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) (version 4.03)<= Grade 1 at the time of randomization.Subjects with diarrhoea with any grade of severity within 14 days prior to randomisation are excluded from LAP117314
- Prior treatment with radiation therapy is permitted provided that at least 2 weeks have elapsed since the last fraction of radiation therapy prior to treatment with Octreotide if randomised to receive Octreotide or the first dose of Lapatinib with Capecitabine if randomised to receive no Octreotide, and all radiation therapy related AEs are <= Grade 1 at the time of randomization
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion criteria:
- Concurrent treatment with an investigational agent or concurrent participation in another clinical study
- Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to treatment with Octreotide for subjects randomised to receive Octreotide or the first dose of Lapatinib and Capecitabine for subjects randomised to receive no Octreotide
- Treatment with Octreotide within the 3 months prior to randomization
- Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy (including an Epidermal growth factor receptor (EGFR) and/or HER2 inhibitor), or hormonal therapy for treatment of cancer
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent, unless a legally acceptable representative could provide informed consent (if in accordance with the policies of the local Ethics Committee)
- Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety or compliance with study procedures
- Diarrhoea with any grade of severity within 14 days prior to treatment with Octreotide for subjects randomised to receive Octreotide or within 14 days prior to the first dose of Lapatinib and Capecitabine for subjects randomised to receive no Octreotide
- Malabsorption syndrome, inflammatory bowel disease (ulcerative colitis, Chrohn’s disease), irritable bowel syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
- Pregnant or lactating subjects
- French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days or 5 half-lives, whichever is longer, preceding the first dose of protocol treatment
- Prior treatment with Lapatinib
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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