WithdrawnPhase 1

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years

Stopped: The company currently does not have plans to conduct this study

Plain-language summary

The purpose of this study is to determine the dosing strategy for adolescents aged 2 to 5 years.

Age range2 Years – 5 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.

✓. 2 to 5 years of age inclusive at screening.
✓. Written parental (or appropriate legal representative) IRB approved informed consent 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.
✕. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
✕. Any conditions associated with non-compliance.

Plasma concentration

Timeframe: Up to 7 days

NCT IDNCT01596426

SponsorKyowa Kirin Pharmaceutical Development Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Who can participate

Age range2 Years – 5 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.

✓. 2 to 5 years of age inclusive at screening.
✓. Written parental (or appropriate legal representative) IRB approved informed consent 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.
✕. Administration of other investigational drugs within 30 days preceding the screening visit, except for anticancer treatments.
✕. Any conditions associated with non-compliance.