XK469 in Treating Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT00028548 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : April 25, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific | Drug: R(+)XK469 | Phase 1 |
OBJECTIVES:
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies |
Study Start Date : | January 2002 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: XK469 |
Drug: R(+)XK469 |

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT and AST no greater than 2.5 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
Cardiovascular:
- Ejection fraction at least 50%
- No significant arrhythmias
- No congestive heart failure
Other:
- 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)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent prophylactic colony-stimulating factors
Chemotherapy:
- 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
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow-containing areas
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 4 weeks since prior investigational agents
- No other concurrent experimental anticancer therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00028548
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 |
Study Chair: | Patricia M. LoRusso, DO | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Patricia LoRusso, Principal Investigator, Barbara Ann Karmanos Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00028548 History of Changes |
Other Study ID Numbers: |
CDR0000069103 U01CA062487 ( U.S. NIH Grant/Contract ) P30CA022453 ( U.S. NIH Grant/Contract ) WSU-C-2346 NCI-4550 WSU-T-2001 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | April 25, 2014 |
Last Verified: | April 2014 |
unspecified adult solid tumor, protocol specific |