XK469 in Treating Patients With Advanced 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: NCT00028548
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 25, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute

January 4, 2002
January 27, 2003
April 25, 2014
January 2002
December 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00028548 on Archive Site
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XK469 in Treating Patients With Advanced Solid Tumors
Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of XK469 in treating patients who have advanced solid tumors.


  • Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of XK469 in patients with advanced solid tumors.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine, preliminarily, any anti-tumor activity of this drug in these patients.
  • Determine the drug metabolism, drug interaction potential, molecular and cellular predictors of efficacy and toxicity, and clinical confirmation of molecular responses in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive XK469 IV over 20 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity.

Once the MTD is determined, up to 15 patients are treated at that dose. Patients in the expanded MTD cohort also receive oral NovaSoy® soybean extract twice daily for the study duration.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15 months.

Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: R(+)XK469
Experimental: XK469
Intervention: Drug: R(+)XK469
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
December 2006
December 2006   (Final data collection date for primary outcome measure)


  • Histologically or cytologically confirmed non-hematological cancer that is unresponsive to available therapies or for which there is no known effective treatment
  • Measurable or evaluable disease

    • Clinical or radiological evidence of disease required
  • No active brain metastases



  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal


  • Creatinine less than 1.5 mg/dL


  • Ejection fraction at least 50%
  • No significant arrhythmias
  • No congestive heart failure


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No dementia or altered mental status
  • No known HIV infection
  • No active infection
  • No other serious uncontrolled medical disorder that would preclude study participation
  • No known allergies to soy products, rice flour, or gelatin (if receiving study dietary soy supplementation)


Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • No concurrent prophylactic colony-stimulating factors


  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • Prior taxanes allowed
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except hormone replacement therapy or medication used to maintain castrate status for patients with progressive hormone-refractory prostate cancer


  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow-containing areas
  • No concurrent radiotherapy


  • Not specified


  • At least 4 weeks since prior investigational agents
  • No other concurrent experimental anticancer therapy
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U01CA062487 ( U.S. NIH Grant/Contract )
P30CA022453 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP