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Keck Medical Center of USC
Phase I Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-906024 in Subjects with Advanced Solid Tumors.
Closed to Accrual with Ongoing Follow-up
Anti-Angiogenesis, Chemotherapy: Systemic
Defintions of terms and FAQ about clinical trials.
Anthony El-Khoueiry, M.D.
Other Trial Staff:
Xiomara Menendez, R.N., Jubilee Acap, R.N., Khatchik Karakozian, D.M., Jennifer Berg, D.M.
to see study documents.
You may participate in this study if:
For the dose escalation phase: Subjects with advanced or metastatic solid tumors (non-hematologic) refractory to or relapsed from standard therapies or for which there is no known effective treatment. For the dose expansion phase: Subjects with triple-negative breast cancer, colorectal cancer (CRC), or non-small cell lung cancer (NSCLC), refractory to or relapsed from standard therapies, or for which there is no known effective treatment. In addition to these 3 tumor types, up to 5 subjects with advanced or metastatic solid tumors refractory to or relapsed from standard therapies or for which there is no known effective treatment, with other tumor types for which Notch activation has been demonstrated with pre-clinical or clinical data (e.g., pancreatic, ovarian, melanoma), may be enrolled in the expansion cohort. Note: Subjects with CRC must have known K-Ras mutation status.
Subjects must have accessible tumor for pre-treatment biopsy at acceptable clinical risk (as judged by the investigator) and must consent to pre-treatment and on-treatment tumor biopsies
Life expectancy of at least 3 months
Men and women, 18 years of age or greater
ECOG performance status score 0-1
AGC = / > 1.5; absolute lymphocyte count = / > 500; platelets = / > 100,000; Hgb = / > 9.0
Total bilirubin < / = 1.5 x uln (except known Gilbert’s disease); SGOT or SGPT < / = 3 x uln
Creatinine < / = 1.5 x uln
Prior anti-cancer treatments are permitted (i.e., chemotherapy, RT, hormonal, or immunotherapy). Toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery must either have resolved, returned to baseline, or been deemed irreversible.
At least 4 weeks or 5 half-lives (whichever is longer) must have elapsed from last dose of prior anti-cancer therapy and the initiation of study therapy, with the exception of the following: At least 6 weeks must have elapsed between prior therapy with nitrosoureas, mitomycin-C, and liposomal doxorubicin. For biologics (e.g., monoclonal antibodies) and extended-release formulations, the washout period must extend 1 month beyond the recommended dosing interval.
Signed an approved study-specific informed consent and HIPAA
You may not participate in this study if:
Known or suspected brain metastases, primary brain tumors, or brain as the only site of disease
Pregnant or breastfeeding women. WOCBP must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product. Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception throughout the study and for up to 12 weeks after the last dose of investigational product.
Evidence of uncontrolled, active infection, requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy 7 days or less prior to administration of study medication
Failure to recover from acute, reversible effects of prior chemotherapy
Current or recent (within 3 months of study drug administration) GI disease such as chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease
Conditions requiring chronic systemic glucocorticoid use, such as autoimmune disease or severe asthma
Uncontrolled or significant cardiovascular disease including:  Uncontrolled HTN - systolic BP >150 mmHg or diastolic BP >90 mmHg despite optimal medical management;  CHF NYHA class 3 or greater within 3 months;  LVEF < LLN by MUGA or ECHO;  Active CAD, unstable or newly diagnosed angina or MI in the past 6 months;  History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as v-tach, v-fib, or Torsade de Pointes). Controlled AF is not an exclusion criterion.
History of medically significant thromboembolic events or bleeding diathesis within the past 6 months, such as CVA (including TIA), PE, pulmonary hemorrhage >2 teaspoonfuls/24hrs or repeated pulmonary hemorrhage, GI hemorrhage requiring transfusion or procedural intervention
Required anti-coagulation therapy with an agent such as warfarin or heparin
Subjects with concomitant second malignancies (except adequately treated non-melanomatous skin cancers or in-situ bladder, breast or cervical cancers) are excluded, unless a CR was achieved at least 3 years prior to study entry and no additional therapy is required or anticipated to be required during the study period
Serious uncontrolled medical disorder which would impair the ability of the subject to receive protocol therapy
Incomplete recovery from toxicity of surgery or other procedures prior to start of study drug
Inability to be venipunctured and/or tolerate venous access
Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Uncontrolled (= / > Gr 2) hypertriglyceridemia (fasting triglycerides >300 mg/dl)
Any of the following on 12-lead ECG prior to study drug administration, confirmed by repeat.  QRS = / > 120 msec;  QT = / > 500 msec;  QTcF = / > 450 msec
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or HIV-2 antibody
History of allergy to BMS-906024-related compounds
History of Gr 3 or 4 infusion-related reaction to Cremophor-containing compounds despite pre-medication with H1- and H2-blockers
Prior exposure to BMS-906024 or other Notch inhibitors
Exposure to any investigational drug within 4 weeks or 5 half-lives (whichever is longer) of or concurrent with study drug administration
Use of any herbal supplements within 1 week prior to study drug administration
Use of medications causing Torsades de Pointes within 1 week or 5 half-lives (whichever is longer)
Use of strong inhibitors of CYP3A4 within 1 week or 5 half-lives (whichever is longer) or strong inducers of CYP3A4 within 2 weeks or 5 half-lives (whichever is longer)
Prior therapeutic radiation to = / > 30% of bone marrow
Concurrent chemotherapy, hormonal therapy, immunotherapy regimens, or RT, standard or investigational
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.