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Phenoxodiol in Treating Patients With Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022295
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: idronoxil Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
  • Determine the steady-state pharmacokinetics of this drug in these patients.
  • Determine the tumor response in patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of phenoxodiol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy
Study Start Date : August 2001
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed solid tumor

    • Refractory to standard therapy OR
    • No standard therapy exists
  • No breast cancer
  • No active CNS metastases

    • Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months


  • Platelet count greater than 100,000/mm^3
  • WBC greater than 3,000/mm^3
  • Neutrophil count greater than 1,500/mm^3
  • Hemoglobin greater than 10 g/dL (9 g/dL for women)


  • Bilirubin less than 1.2 mg/dL
  • Transaminases no greater than 3 times upper limit of normal


  • Creatinine no greater than 1.4 mg/dL


  • No active infection
  • No contraindication to the insertion of a vascular access device
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No concurrent systemic anticancer immunotherapy


  • No concurrent systemic anticancer chemotherapy

Endocrine therapy:

  • No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists


  • See Disease Characteristics
  • Concurrent localized radiotherapy for control of local disease complications allowed


  • See Disease Characteristics


  • Recovered from prior antineoplastic therapy
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational drugs

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 identifier (NCT number): NCT00022295

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United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Kazia Therapeutics Limited
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Study Chair: Graham Kelly, PhD MEI Pharma, Inc.
Layout table for additonal information Identifier: NCT00022295    
Other Study ID Numbers: CDR0000068802
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 26, 2013
Last Verified: March 2007
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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