Dose Escalation Study of SH U04722 in Solid Tumors

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

Sponsors

Lead Sponsor: Bayer

Source Bayer
Brief Summary

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.

Detailed Description

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.

Overall Status Terminated
Start Date January 2007
Completion Date October 2007
Primary Completion Date October 2007
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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)
Secondary Outcome
Measure Time Frame
The number of patients with DLT observed by the end of Week 8
dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing
Enrollment 10
Condition
Intervention

Intervention Type: Drug

Intervention Name: SH U04722

Arm Group Label: Arm 1

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 20 Years

Maximum Age: 74 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bayer Study Director Study Director Bayer
Location
Facility:
| Hidaka-shi, Saitama, 350-1298, Japan
| Iruma-gun, Saitama, 350-0495, Japan
| Koutou-ku, Tokyo, 135-8850, Japan
Location Countries

Japan

Verification Date

December 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Arm 1

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov