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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02294786
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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
• Scientific 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
• Date of first enrolment: December 17, 2014
• Target sample size: 62
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02294786
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia, France, Greece, Hong Kong, Israel, Italy, Poland, Russian Federation, United Kingdom

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & 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:

1. 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);

2. 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

- Prior treatment with Lapatinib

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Cancer

Intervention(s)

Drug: Octreotide

Drug: Lapatinib

Drug: Capecitabine

Primary Outcome(s)

Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks) [Time Frame: Up to 24 weeks]

Secondary Outcome(s)

Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine [Time Frame: Up to 24 weeks]

Proportion of Subjects Requiring Use of Diarrhoea-related Intravenous Fluids [Time Frame: Up to 24 weeks]

Proportion of Subjects Taking Anti-diarrhoeal Medication as Recorded in the DMD [Time Frame: Up to 24 weeks]

Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity [Time Frame: Up to 24 weeks]

Clinical Benefit Response (up to 24 Weeks) [Time Frame: Up to 24 weeks]

Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks) [Time Frame: 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) [Time Frame: Up to 24 weeks]

Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine [Time Frame: Up to 24 weeks]

Proportion of Subjects Contacting Other Non-hospital Healthcare Professionals to Discuss Diarrhoea as Recorded in the DMD [Time Frame: Up to 24 weeks]

Number of Lapatinib and Capecitabine Tablets Dispensed and Returned [Time Frame: Up to 24 weeks]

Proportion of Subjects Taking Anti-diarrhoeal Medication [Time Frame: Up to 24 weeks]

Duration of Diarrhoea of Any Grade of Severity [Time Frame: Up to 24 weeks]

Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine [Time Frame: Up to 24 weeks]

Proportion of Subjects Making Dietary Changes Due to Diarrhoea as Recorded in the DMD [Time Frame: 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 [Time Frame: 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 [Time Frame: Up to 24 weeks]

Overall Response Rate (up to 24 Weeks) [Time Frame: Up to 24 weeks]

Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks) [Time Frame: Up to 24 weeks]

Proportion of Subjects Who Had Unscheduled Visits to Healthcare Professionals Due to Diarrhoea [Time Frame: Up to 24 weeks]

Secondary ID(s)

117314

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02294786