Dose Escalation Study of SH U04722 in Solid Tumors

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00375453
First received: September 12, 2006
Last updated: July 14, 2009
Last verified: July 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 August 28, 2014