Overview

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyowa Kirin Pharmaceutical Development Ltd
Prostrakan Pharmaceuticals
Treatments:
Granisetron
Criteria
Inclusion Criteria:

1. 13 to 17 years of age inclusive at screening.

2. Written patient or parental (or appropriate legal representative) IRB approved
informed consent as appropriate.

3. Written patient assent (as appropriate).

4. Confirmed malignancy.

5. Scheduled to receive 2 or more cycles* of emetogenic chemotherapy requiring 5-HT3
antagonist treatment.

6. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per
cycle, as CINV prophylaxis.

- The cycles of chemotherapy must be consecutive (i.e. one followed by the other)
but do not have to be the first and second cycle of a line of treatment.

Exclusion Criteria:

1. Hypersensitivities, allergies or contraindications to study medications; intolerance
of medical tape or sticking plaster.

2. Clinical or laboratory signs and symptoms of significant cerebral, cardiovascular,
respiratory, renal, hepatobiliary, pancreatic or infectious disease, which in the
Investigator's judgment may interfere with the study assessment or completion of the
study.

3. Patients with a known history or predisposition to cardiac conduction interval
abnormalities, including QT Syndrome, or known family history of long QT Syndrome or
taking medications that are known to prolong the QT interval.

4. Patients scheduled to have routine surgery during the study duration.

5. Patients with a life expectancy of < 6 months.

6. Scarring or significant skin disease on both upper arms.

7. Female patients who are pregnant or breast-feeding. All post menarche female patients
must have a pregnancy test at screening.

8. Patients who are known or thought to be sexually active must use effective birth
control.**

9. Administration of other investigational drugs within 30 days preceding the screening
visit, except for anticancer treatments.

10. Any conditions associated with non-compliance.

- Effective birth control includes absolute abstinence, or double barrier birth
control methods, i.e. condom and one of the following: combined oral
contraceptive, diaphragm, depot contraceptive injection.