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Dose Escalation Study of SH U04722 in Solid Tumors

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ClinicalTrials.gov Identifier: NCT00375453
Recruitment Status : Terminated
First Posted : September 13, 2006
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Tumors Drug: SH U04722 Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007
Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1 Drug: SH U04722


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. The number of patients with DLT observed by the end of Week 8
  2. dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375453


Locations
Japan
Hidaka-shi, Saitama, Japan, 350-1298
Iruma-gun, Saitama, Japan, 350-0495
Koutou-ku, Tokyo, Japan, 135-8850
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00375453     History of Changes
Other Study ID Numbers: 91526
310681
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Paclitaxel
Advanced Solid Tumors