CompletedPhase 1

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

United States19 participantsStarted 2012-05

Plain-language summary

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

Age range13 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 13 to 17 years of age inclusive at screening.
✓. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
✓. Written patient assent (as appropriate).
✓. Confirmed malignancy.
✓. Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
✓. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

✕. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
✕. 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.
✕. 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.
✕. Patients scheduled to have routine surgery during the study duration.
✕. Patients with a life expectancy of \< 6 months.
✕. Scarring or significant skin disease on both upper arms.
✕. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
✕. Patients who are known or thought to be sexually active must use effective birth control.\*\*

Plasma concentration

Timeframe: Up to 7 days

NCT IDNCT01596400

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

Who can participate

Age range13 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 13 to 17 years of age inclusive at screening.
✓. Written patient or parental (or appropriate legal representative) IRB approved informed consent as appropriate.
✓. Written patient assent (as appropriate).
✓. Confirmed malignancy.
✓. Scheduled to receive 2 or more cycles\* of emetogenic chemotherapy requiring 5-HT3 antagonist treatment.
✓. Scheduled to receive one or more consecutive days of 5-HT3 antagonist treatment, per cycle, as CINV prophylaxis.

✕. Hypersensitivities, allergies or contraindications to study medications; intolerance of medical tape or sticking plaster.
✕. 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.
✕. 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.
✕. Patients scheduled to have routine surgery during the study duration.
✕. Patients with a life expectancy of \< 6 months.
✕. Scarring or significant skin disease on both upper arms.
✕. Female patients who are pregnant or breast-feeding. All post menarche female patients must have a pregnancy test at screening.
✕. Patients who are known or thought to be sexually active must use effective birth control.\*\*