BMS-214662 in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

Phase I trial to study the effectiveness of BMS-214662 in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Key facts

Study ID

NCT00006242

Run by

National Cancer Institute (NCI)

People needed

40

Starts

2000-07-01

Last updated by the study team

2013-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic or inoperable malignancy, other than leukemia or a primary CNS tumor, for which there is no known curative or survival prolonging palliative therapy, or failure of these therapies
• Life expectancy >= 2 months
• ECOG performance status 0-1
• ANC >= 1,500/mm\^3
• Platelets >= 100,000/mm\^3
• SGOT and SGPT =< 2.5 times the upper limit of normal (ULN)
• Total bilirubin =< ULN
• Serum creatinine =< ULN
• Calculated or measured creatinine clearances (Cockcroft-Gault formula) >= 50 ml/minute
• >= 3 weeks since major surgery
• >= 4 weeks since chemotherapy or radiation therapy
• No uncontrolled serious medical or psychiatric illness
• Women of childbearing potential must not be pregnant or lactating; all women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L of beta-HCG) within 72 hr prior to receiving the study medication; BMS 214662 has antiproliferative effects which may be harmful to the developing fetus or nursing infant
• Fertile males and females must use adequate contraception
• Signed informed consent

You may not qualify if…

• Any history of clinically significant atrial or ventricular arrhythmias, any history of second or third degree heart block, or prolonged QTc interval (greater than 450 ms) on electrocardiogram
• Active brain metastases including evidence of cerebral edema by CT scan or MRI, or progression from prior imaging study, any requirement for steroids, or clinical symptoms of/from brain metastases
• Received any drugs within 7 days prior to receiving study drug therapy, which are known to be substrates of cytochrome P450-3A4 (CYP3A4)
• Patients should not receive concurrent therapy with known CYP3A4 substrates while on study and for at least 1 week following the last dose of BMS-214662; this is due to the CYP3A4 inhibitory potential of BMS-214662; a representative list of commonly prescribed known CYP3A4 substrates includes: terfenadine, astemizole, triazolam, midazolam, cisapride, bepridil, rifabutin, simvastatin, lovastatin, and propafenone
• Patients receiving therapy with BMS-214662 should not receive concomitant therapy with NSAIDs or other potentially nephrotoxic medications for at least 2 days before and after administration of BMS-214662
• Patients with known pre-existing renal disease are not eligible

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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