A study to assess the use of Octreotide in the prevention or reduction of diarrhoea associated with lapatinib and capecitabine treatment in patients with metastatic breast cancer.
- Conditions
- Diarrhoea associated with treatment with lapatinib and capecitabine for metastatic breast cancerMedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000256-28-PL
- Lead Sponsor
- GlaxoSmithKline Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 140
Deviations from the inclusion criteria are not allowed because they can potentially
jeopardize the scientific integrity of the study, regulatory acceptability or subject safety.
Therefore, adherence to the criteria as specified in the protocol is essential.
Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Signed written informed consent.
2. 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.
3. Females age >or=18 years old.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 4)
5. Life expectancy of at least 12 weeks.
6. Able to swallow and retain oral medications.
7. 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) during the study and continuing for at least 4 weeks after the final dose of treatment with lapatinib and capecitabine. Acceptable contraceptive methods are described in Section 7.5.1.
8. Subjects must complete all screening assessments as outlined in the protocol.
9. Subjects must complete the 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.
10. Prior treatment with other chemotherapeutic agents or endocrine therapy is permitted. All prior treatment related toxicities, except diarrhoea and alopecia,
must be 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.
11. 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. Other country-specific
criteria are included in Appendix 5.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98
Deviations from exclusion criteria are not allowed because they can potentially
jeopardize the scientific integrity of the study, regulatory acceptability or subject safety.
Therefore, adherence to the criteria as specified in the protocol is essential.
Subjects meeting any of the following criteria must not be enrolled in the study:
1. Concurrent treatment with an investigational agent or concurrent participation in another clinical study.
2. 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.
3. Treatment with octreotide within the 3 months prior to randomization.
4. Concurrent chemotherapy, radiation therapy, immunotherapy, biologic therapy
(including an EGFR and/or HER2 inhibitor), or hormonal therapy for treatment of cancer.
5. 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).
6. 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.
7. 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.
8. 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.
9. Pregnant or lactating subjects.
10. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method