Trial Condition(s):
Tumors
Dose Escalation Study of SH U04722 in Solid Tumors
Bayer Identifier:
91526
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This study will evaluate the safety and tolerability of SH U04722 in patients with solid tumor cancers. In addition, this study will identify the recommended dose and administration schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH U04722 in patients with solid tumors.
Inclusion Criteria
-Refractory to conventional antineoplastic treatment or no standard therapy option available-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).
Exclusion Criteria
- 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 U04722 -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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Gan Ken Ariake Byoin Koutou-ku, Japan, 135-8850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Ikadaigaku Byoin Iruma-gun, Japan, 350-0495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitamaikadaigaku Kokusai Iryo Senta Hidaka-shi, Japan, 350-1298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- 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)Timeframe:
Secondary Outcome
- The number of patients with DLT observed by the end of Week 8Timeframe:
- dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosingTimeframe:
Additional Information
Copyright © Bayer
Powered by
