stop_circleTerminated/Withdrawn

Tumors

Bayer Identifier:

91526

ClinicalTrials.gov Identifier:

NCT00375453

EudraCT Number:

Not Available

EU CT Number:

Not Available
Dose Escalation Study of SH U04722 in Solid Tumors

Trial 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.

Key Participants Requirements

Sex

Both

Age

20 - 74 Years
  • -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).
  • - 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)

Trial summary

Enrollment Goal
10
Trial Dates
January 2007 - October 2007
Phase
Phase 1
Could I Receive a placebo
No
Products
Tocosol-Paclitaxel (BAY86-5312)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Gan Ken Ariake ByoinKoutou-ku, 135-8850, Japan
Completed
Saitama Ikadaigaku ByoinIruma-gun, 350-0495, Japan
Completed
Saitamaikadaigaku Kokusai Iryo SentaHidaka-shi, 350-1298, Japan

Primary Outcome

  • 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)
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    Safety Issue:
    None

Secondary Outcome

  • The number of patients with DLT observed by the end of Week 8
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    Safety Issue:
    None
  • dose intensity (whether or not 75% of the planned dose can be done) for 8 weeks after the first dosing
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    Safety Issue:
    None

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
N/A

Additional Information

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