Dose Escalation Study of SH U04722 in Solid Tumors
This study has been terminated.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00375453
First received: September 12, 2006
Last updated: July 14, 2009
Last verified: July 2009
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tumors |
Drug: SH U04722 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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:
- 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
| Estimated Enrollment: | 18 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2007 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 | Drug: SH U04722 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Schering Pharma AG |
| ClinicalTrials.gov Identifier: | NCT00375453 History of Changes |
| Other Study ID Numbers: | 91526, 310681 |
| Study First Received: | September 12, 2006 |
| Last Updated: | July 14, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
Paclitaxel Advanced Solid Tumors |
ClinicalTrials.gov processed this record on May 21, 2013