- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375453
Dose Escalation Study of SH U04722 in Solid Tumors
December 30, 2014 updated by: Bayer
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saitama
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Hidaka-shi, Saitama, Japan, 350-1298
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Iruma-gun, Saitama, Japan, 350-0495
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Tokyo
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Koutou-ku, Tokyo, Japan, 135-8850
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
Outcome Measure |
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The number of patients with DLT observed by the end of Week 8
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dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 12, 2006
First Submitted That Met QC Criteria
September 12, 2006
First Posted (Estimate)
September 13, 2006
Study Record Updates
Last Update Posted (Estimate)
December 31, 2014
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91526
- 310681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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BayerCompleted