Phase I, Open-label, Dose Escalation Study for Evaluation of Safety, Tolerability, Pharmacokinetics, and Tumor-suppressive Efficacy of SH U04722 in Patients With Solid Tumors
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
- Refractory to conventional antineoplastic treatment or no standard therapy option
- ECOG Performance Status score of < 2
- Agreement not to take vitamin E products such as Juvela (except for over-the-counter
[OTC] and diet supplements).
- Patients treated with other unapproved drugs/investigational drugs, chemotherapy,
biological response modifiers, immunotherapy or endocrinotherapy within 4 weeks prior
to entry in this study or nitrosoureas within 6 weeks before initial dosing of SH
- Patients on concurrent therapy with warfarin or coumarin derivatives.
- Patients who had radiation therapy within 2 weeks prior to entry into this study.
- Patients with a history of serious hypersensitivity to taxanes.
- Patients with current peripheral neuropathy (? Common Terminology Criteria for
Adverse Events [CTCAE] Grade 2)
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The number of patients with dose limiting toxicity (DLT) observed between Days 1 and 21 after start of treatment (after first 3 weekly administrations of SH U04722 plus 7 days)
Bayer Study Director
Japan: Ministry of Health, Labor and Welfare
- Advanced Solid Tumors