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||Multiple sites|
|Trial Type||Treatment (TRE)|
|Title||A Phase I, Open-label, Dose-Escalation, Safety and Pharmacokinetic Study of ABC294640 in Patients with Advanced Solid Tumors|
|Primary Investigator||Carolyn Britten email@example.com|
|Study Coordinator||Alan Brisendine 843-792-9007 firstname.lastname@example.org|
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 greater than or equal to 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 the study:
• 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
1. New York Heart Association Class III or IV, cardiac disease, myocardial
infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
2. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
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.
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 organ tumors
|Available Documents|| HIPAA |