Status:
COMPLETED
Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
Lead Sponsor:
Celgene
Conditions:
Hematological Neoplasms
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Foo...
Detailed Description
Stage I - Pharmacokinetics (Bioequivalence) Subjects will be randomized to receive CC-486 300 mg orally on each of the two pharmacokinetic (PK) study days based on the dosing sequences they are rando...
Eligibility Criteria
Inclusion
- Subjects must satisfy the following criteria to be enrolled in the study:
- Age ≥ 18 years of age at the time of signing the informed consent document.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- Documented diagnosis of any of the following:
- Myelodysplastic Syndrome (MDS) according to the World Health Organization (WHO) 2008 classification
- Acute myeloid leukemia (AML)
- Multiple myeloma (MM), limited to those patients for whom standard curative or palliative treatments do not exist or are no longer effective
- Non-Hodgkin's lymphoma (NHL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective,
- Hodgkin's lymphoma (HL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective
- Metastatic or inoperable solid tumors\* (except gastrointestinal tumors or tumors that originated or metastasized to the liver) for which no standard treatment exists, or have progressed or recurred following prior therapy.
- Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population.
- Patients with a history of treated brain metastases should be clinically stable for ≥ 4 weeks prior to signing the informed consent. Glucocorticoid therapy for central nervous system (CNS) edema is permitted if ≤ 20 mg of prednisolone (or equivalent).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Have a life expectancy of ≥ 3 months.
- Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by:
- Serum creatinine \< 2.5 x the upper limit of normal (ULN)
- An average calculated creatinine clearance \> 30 mL/min/1.73 m\^2
- Have organ and marrow function at the screening and pre-dose visits as defined by:
- Hemoglobin ≥ 8 g/dL
- Absolute neutrophil count (ANC) ≥ 0.75 x 10\^3/uL without treatment with a myeloid growth factor within 3 days prior to first dose of IP
- Platelets ≥ 30 x 10\^3/uL
- Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2 x ULN
- Alanine aminotransferase (ALT) ≤ 2 x ULN
- Have a 12-lead Electrocardiogram (ECG) that is not clinically significant at screening, as determined by the investigator
- Females of childbearing potential (FCBP) may participate, providing the subject meets the following conditions:
- Agree to use at least two effective contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) or agree to practice true abstinence throughout the study, and for 3 months following the last dose of IP; and
- Negative serum pregnancy test at screening (sensitivity of at least 25 mIU/mL); (Note that the screening serum pregnancy test can be used as the test prior to starting IP in the pharmacokinetics phase if it is performed within the 72-hour timeframe), and
- Negative serum or urine pregnancy test (investigator's discretion; sensitivity of at least 25 mIU/mL) within 72 hours prior to starting IP in the extension phase. (Note: subjects must have negative serum or urine pregnancy test prior to dosing on Day 1 of each treatment cycle in the extension phase.)
- Male subjects must:
- a. Practice true abstinence\* or agree to the use of at least two physician-approved contraceptive methods throughout the course of the study and should avoid fathering a child during the course of the study for at least 3 months following the last dose of IP.
- \* True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. \[Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
- Able to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Women who are pregnant or nursing (lactating).
- Gastrointestinal tumors, tumors that have originated or metastasized to the liver, or other tumors known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product (IP) administration.
- Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration.
- Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator.
- Significant active cardiac disease within the previous 6 months, including:
- New York Heart Association (NYHA) class IV congestive heart failure
- Significant cardiac arrhythmia or unstable angina or angina requiring surgical or medical intervention; and/or
- Myocardial infarction
- Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of Azacitidine.
- Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
- History of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition that confounds the ability to interpret data from the study
- Impaired ability to swallow oral medication
- Any condition that confounds the ability to interpret data from the study
Key Trial Info
Start Date :
October 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2018
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02223052
Start Date
October 27 2014
End Date
December 18 2018
Last Update
May 12 2020
Active Locations (10)
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1
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
2
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
3
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
University of Iowa
Iowa City, Iowa, United States, 52242