Location: PhaseI :101504
|Program||All Programs, Biliary, Bladder, Breast, Cervical, Colon, Endometrial, Esophageal, Gastric, Gastrointestinal, Genitourinary, Gynecologic Oncology, Head & Neck, Kidney (Renal), Larynx, Liver, Melanoma, Non-Small Cell Lung Cancer (NSCLC), Ovarian, Pancreatic, Phase I, Prostate, Rectal, Sarcoma, Small Cell Lung Cancer (SCLC), Thoracic, Thyroid, Uterine|
|Diagnosis Region||Anus, Bones and Joints, Brain and Nervous System, Breast-Female|
|Title||A Phase I, Open-label, Dose-Escalation, Safety and Pharmacokinetic Study of ABC294640 in Patients with Advanced Solid Tumors|
|Primary Investigator||Melanie Thomas email@example.com|
|Study Coordinator||Alan Brisendine 843-792-9007 firstname.lastname@example.org|
Each of the following criteria must be met in order for a patient to be considered eligible
for enrollment. Study-specific evaluations may be performed only after written informed
consent has been obtained.
1. Patients with histologically confirmed solid organ carcinomas.
2. Tumor progression after receiving standard/approved chemotherapy or as firstline
therapy for malignancies where there is no standard therapy.
3. One or more tumors measurable on CT scan per RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Life expectancy of at least 3 months.
6. Age 18 years.
7. Signed, written IRB-approved informed consent.
8. A negative pregnancy test (if female).
9. Acceptable liver function:
Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)
AST (SGOT), ALT (SGPT) 3 x ULN (CTCAE Grade 1 baseline)
Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
10. Acceptable hematologic status:
Absolute neutrophil count 1000 cells/mm3
Platelet count 75,000 (plt/mm3) (CTCAE Grade 1 baseline)
Hemoglobin 9 g/dL
11. Acceptable blood sugar control:
– Fasting glucose value < 160 mg/dL (CTCAE Grade 1 baseline)
12. Urinalysis: No clinically significant abnormalities.
13. PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may
contribute to prolonged PT/PTT.
14. For men and women of child-producing potential, willingness to use of effective
contraceptive methods during the study. If female (or female partner of male
subject), is either not of childbearing potential (defined as postmenopausal for ≥
1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or
hysterectomy]) or practicing 1 of the following medically acceptable methods of birth control and agrees to continue with the regimen throughout the duration of
• Oral, implantable or injectable contraceptives for 3 consecutive months
before the Baseline/Randomization Visit.
• Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle
before the Baseline/Randomization Visit).
• Intrauterine device (IUD).
• Double barrier method (condoms, sponge, diaphragm or vaginal ring with
spermicidal jellies or cream).
To be eligible for inclusion in Part II, patients must meet the eligibility for Part 1 as well
as the following:
Patients with histologically confirmed pancreatic cancer for whom there is no
A patient will be excluded from both Part I and Part II of the study if he or she meets any
of the following criteria:
1. New York Heart Association Class III or IV, cardiac disease, myocardial
infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia
2. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
3. Pregnant or nursing women. NOTE: Women of child-bearing potential and men
must agree to use adequate contraception (hormonal or barrier method of birth
control; or abstinence) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.
4. Treatment with radiation therapy, surgery, chemotherapy, or investigational
therapy within one month prior to study entry.
5. Unwillingness or inability to comply with procedures required in this protocol.
6. Known infection with HIV.
7. Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other
conditions) that could compromise protocol objectives in the opinion of the
Investigator and/or the Sponsor.
8. Patients who are currently receiving any other investigational agent.
9. Patients who are receiving drugs that are sensitive substrates of CYP450 1A2,
3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 longer) before starting treatment with ABC294640 and either replaced with
another appropriate medication or not given for the duration of the clinical study.
(A list of commonly used drugs that are that are sensitive substrates of CYP450
1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major
CYP450 isozymes with the half-life of each drug identified, is included as
10. Patients who are currently taking Coumadin or Coumadin derivatives.
11. Patients who have received any antineoplastic therapy within 1 month prior to
starting treatment with ABC294640 or who have not adequately recovered from
side effects and toxicities of previous antineoplastic therapy.
To assess safety and determine the maximum tolerated dose (MTD) and
the dose limiting toxicities (DLT) of ABC294640 in patients with solid
To establish the dose of ABC294640 recommended for future phase II
To describe the pharmacokinetics of ABC294640 in patients with solid
To assess antitumor activity of ABC294640in patients with solid organ tumors by objective radiographic assessment using RECIST 1.1 criteria|
|Available Documents|| HIPAA |