Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Celgene Corporation
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT02223052
First received: August 20, 2014
Last updated: October 24, 2016
Last verified: October 2016
  Purpose

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 (Food Effect) with an Extension

This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have 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. Approximately 23 sites in the US and 2 in Canada will participate in this study.


Condition Intervention Phase
Hematological Neoplasms
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Lymphoma
Multiple Myeloma
Acute Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
Neoplasms
Melanoma
Breast Cancer
Metastatic Breast Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Renal Cell Carcinoma
Glioblastoma Multiforme
Osteosarcoma
Sarcoma
Thyroid Cancer
Genitourinary
Drug: CC-486
Drug: Vidaza
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter, Randomized, 2-Period, Crossover Study to Evaluate the Bioequivalence and Food Effect Bioavailability of CC-486 (Oral Azacitidine) Tablets in Adult Cancer Subjects

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Pharmacokinetics Cmax - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    The observed maximum concentration

  • Pharmacokinetics Tmax - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    The observed time to first maximum concentration

  • Pharmacokinetics AUC-t - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from time zero to the last quantifiable time point calculated by the linear trapezoidal rule

  • Pharmacokinetics AUC-infinity - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Area under the concentration time-curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity. It will be calculated as AUC∞ = [AUCt + Ct/λz]. Ct is the last quantifiable concentration

  • Pharmacokinetics λz (Terminal Rate) - Stage I (Bioequivalence) [ Time Frame: Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Terminal phase rate constant, determined by linear regression of the terminal points of the log-linear concentration-time curve

  • Pharmacokinetics Terminal Half-Life (t½) - Stage I (Bioequivalence) [ Time Frame: Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Terminal phase half-life, calculated according to the following equation: t½ = 0.693/λz

  • Pharmacokinetics Apparent total clearance (CL/F) - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Apparent total clearance, calculated as Dose/AUC∞

  • Pharmacokinetics Apparent volume of distribution (Vd/F) - Stage I (Bioequivalence) [ Time Frame: Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose ] [ Designated as safety issue: No ]
    Apparent volume of distribution, calculated according to the equation: Vd/F = (CL/F) / λz

  • Pharmacokinetics Cmax - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    The observed maximum concentration

  • Pharmacokinetics Tmax - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    The observed time to first maximum concentration

  • Pharmacokinetics AUC-t - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Area under the concentration-time curve from time zero to the last quantifiable time point calculated by the linear trapezoidal rule.

  • Pharmacokinetics AUC-infinity - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Area under the concentration time-curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity. It will be calculated as AUC∞ = [AUCt + Ct/λz]. Ct is the last quantifiable concentration.

  • Pharmacokinetics λz (Terminal Rate) - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Terminal phase rate constant, determined by linear regression of the terminal points of the log-linear concentration-time curve

  • Pharmacokinetics Terminal Half-Life (t½) - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Terminal phase half-life, calculated according to the following equation: t½ = 0.693/λz

  • Pharmacokinetics Apparent total clearance (CL/F) - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Apparent total clearance, calculated as Dose/AUC∞

  • Pharmacokinetics Apparent volume of distribution (Vd/F) - Stage II (Food Effect Bioavailability) [ Time Frame: PK Dosing Day 1 and PK Dosing Day 2 prior to each dose administration of IP (CC-486), known as pre-dose, and over the 8-hour period following each dose administration of IP (CC-486) at 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 6, and 8 hours post-dose. ] [ Designated as safety issue: No ]
    Apparent volume of distribution, calculated according to the equation: Vd/F = (CL/F) / λz


Secondary Outcome Measures:
  • Adverse Events (AEs) [ Time Frame: Up to 18 months ] [ Designated as safety issue: Yes ]
    Adverse Event (AE) is defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.


Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CC-486 Arm 1 (Oral Azacitidine) Dosing Sequence 1
Two 150-mg tablets of CC-486 under fasting condition on PK dosing Day 1, followed by one 300-mg tablet of CC-486 on PK dosing Day 2; If PI chooses to treat the patient in the extension phase with Azacitidine, Vidaza (Azacitidine for Injection) 75 mg/m2 intravenously (IV) or subcutaneously (SC) daily x 7 days every 4 weeks for less than or equal to 6 (28-day) cycles will be administered.
Drug: CC-486
Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2
Other Name: Oral Azacitdine
Drug: Vidaza
75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles
Other Names:
  • Azacitidine for Injection
  • AZA
Experimental: CC-486 Arm 2 (Oral Azacitidine) Dosing Sequence 1
One 300-mg tablet of oral CC-486 under fasting condition on PK dosing Day 1, followed by one 300-mg tablet of oral CC-486 under fed condition on PK dosing Day 2; If PI chooses to treat the patient in the extension phase with Azacitidine, Vidaza (Azacitidine for Injection) 75 mg/m2 intravenously (IV) or subcutaneously (SC) daily x 7 days every 4 weeks for less than or equal to 6 (28-day) cycles will be administered.
Drug: CC-486
Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2
Other Name: Oral Azacitdine
Drug: Vidaza
75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles
Other Names:
  • Azacitidine for Injection
  • AZA
Experimental: CC-486 Arm 1 (Oral Azacitidine) Dosing Sequence 2
One 300-mg tablets of CC-486 under fasting condition on PK dosing Day 1, followed by two 150-mg tablets on PK dosing Day 2; If PI chooses to treat the patient in the extension phase with Azacitidine, Vidaza (Azacitidine for Injection) 75 mg/m2 intravenously (IV) or subcutaneously (SC) daily x 7 days every 4 weeks for less than or equal to 6 (28-day) cycles will be administered.
Drug: CC-486
Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2
Other Name: Oral Azacitdine
Drug: Vidaza
75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles
Other Names:
  • Azacitidine for Injection
  • AZA
Experimental: CC-486 Arm 2 (Oral Azacitidine) Dosing Sequence 2
One 300-mg tablet of oral CC-486 under fed condition on PK dosing Day 1, followed by one tablet of 300-mg oral CC-486 under fasted conditions on PK dosing Day 2; if PI chooses to treat the patient in the extension phase with Azacitidine, Vidaza (Azacitidine of Injection) 75 mg/m2 intravenously (IV) or subcutaneously (SC) daily x 7 days every 4 weeks for less than or equal to 6 (28-day) cycles will be administered.
Drug: CC-486
Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2
Other Name: Oral Azacitdine
Drug: Vidaza
75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles
Other Names:
  • Azacitidine for Injection
  • AZA

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 randomized to:

Dosing Sequence 1: 2x150 mg tablets followed by 1x30 mg tablet. Dosing Sequence 2: 1x300 mg tablet followed by 2x150 mg tablets. Each dose will be administered in the clinic at least 48 hours apart between PK dosing day 1 and PK dosing day 2 over a period no longer than 10 days under fasted conditions.

Stage II - Pharmacokinetics (Food Effect)

Subjects will be randomized to receive CC-486 300 mg orally on each of the two PK study days based on the dosing sequences they are randomized to:

Dosing Sequence 1: 1x300 mg tablet under fasted condition followed by 1x300 mg tablet under fed condition.

Dosing Sequence 2: 1x300 mg tablet under fed condition followed by 1x300 mg tablet under fasted condition.

Each dose will be administered in the clinic at least 48 hours apart between PK dosing day 1 and PK dosing day 2 over a period no longer than 10 days. The sponsor will generate the randomization scheme and assign subjects upon enrollment to the appropriate sequence for dosing:

Fasted condition: following an overnight fast of at least 10 hours, subjects will ingest oral Azacitidine with 240 mL of room temperature water. Subjects must fast for a minimum of 4 hours following oral Azacitidine administration. Subjects may drink water as desired, except for 1 hour before and 1 hour after oral Azacitidine administration.

Fed condition: following an overnight fast of at least 10 hours and following the performance of all required pre-dose assessments, subjects randomized to receive test medication in a fed state will begin ingesting a breakfast meal 30 (±5) minutes prior to the planned administration of oral Azacitidine. They will continue the entire meal within 20 to 25 minutes (no less than 20 minutes) from the time the meal is served. Subjects will then ingest oral Azacitidine with 240 mL of room temperature water. Subjects must fast a minimum of 4 hours following oral Azacitidine administration. Subjects may drink water as desired, except for 1 hour before and 1 hour after administration of oral Azacitidine.

Extension Phase (for subjects who have completed PK Stage I or Stage II) Subjects continuing beyond the pharmacokinetics phase (Stage I or Stage II) will enter the extension phase of the study at the discretion of the investigator to receive < 6 (four-week) cycles of Vidaza 75 mg/m2 IV or SC daily for 7 days in the clinic and repeat every 4 weeks per prescribed label at the discretion of the investigator for ≤ 6 (four-week) cycles.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:

    1. Age ≥ 18 years of age at the time of signing the informed consent document.
    2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
    3. Documented diagnosis of any of the following:

      1. Myelodysplastic Syndrome (MDS) according to the World Health Organization (WHO) 2008 classification
      2. Acute myeloid leukemia (AML)
      3. Multiple myeloma (MM), limited to those patients for whom standard curative or palliative treatments do not exist or are no longer effective
      4. Non-Hodgkin's lymphoma (NHL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective,
      5. Hodgkin's lymphoma (HL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective
      6. 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.
    4. 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).
    5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    6. Have a life expectancy of ≥ 3 months.
    7. Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by:

      1. Serum creatinine < 2.5 x the upper limit of normal (ULN)
      2. An average calculated creatinine clearance > 30 mL/min/1.73 m^2
    8. Have organ and marrow function at the screening and pre-dose visits as defined by:

      1. Hemoglobin ≥ 8 g/dL
      2. 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
      3. Platelets ≥ 30 x 10^3/uL
      4. Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN)
      5. Aspartate aminotransferase (AST) ≤ 2 x ULN
      6. Alanine aminotransferase (ALT) ≤ 2 x ULN
    9. Have a 12-lead Electrocardiogram (ECG) that is not clinically significant at screening, as determined by the investigator
    10. 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.)
    11. 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].

    12. Able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

  1. Women who are pregnant or nursing (lactating).
  2. 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.
  3. Had chemotherapy or radiotherapy within 4 weeks prior to the first day of Investigational Product (IP) administration.
  4. Have been treated with an investigational agent within 4 weeks prior to the first day of IP administration.
  5. Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator.
  6. 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
  7. Have known or suspected hypersensitivity to azacitidine or any other ingredient used in the manufacturing of Azacitidine.
  8. 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)
  9. 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.
  10. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  11. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  12. Any condition that confounds the ability to interpret data from the study
  13. Impaired ability to swallow oral medication
  14. Any condition that confounds the ability to interpret data from the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02223052

Contacts
Contact: Michael Pinho mpinho@celgene.com
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, Arizona
Scottsdale Healthcare Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Mayo Clinic - Arizona Recruiting
Scottsdale, Arizona, United States, 85259
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Missouri
Veteran Affairs Medical Center, Research #517 Not yet recruiting
Kansas City, Missouri, United States, 64128
United States, New Jersey
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Cleveland Clinic Foundation Not yet recruiting
Cleveland, Ohio, United States, 44195
United States, South Carolina
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
United States, Tennessee
Vanderbilt- Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6307
United States, Texas
The Methodist Hospital Research Institute l Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Du Lam, MD Celgene
  More Information

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02223052     History of Changes
Other Study ID Numbers: CC-486-CAGEN-001 
Study First Received: August 20, 2014
Last Updated: October 24, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
CC-486
Oral Azacitidine
Soli Tumor Malignancy
Hematological Malignancy
Leukemia
Lymphoma
Multiple Myeloma
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Neoplasms
Melanoma
Breast Cancer
Metastatic Breast Cancer
Non-Small Cell Lung Cancer
Small Cell Lung Cancer
Renal Cell Carcinoma
Glioblastoma Multiforme
Brain Cancer
Kidney Cancer
Lung cancer
Blood Cancer
Thyroid Cancer
Bone Cancer
Bone Metastasis
Testicular Cancer
Prostate Cancer
Bladder Cancer
Ovarian Cancer
Skin Cancer
Cancer general

Additional relevant MeSH terms:
Lymphoma
Leukemia
Breast Neoplasms
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Leukemia, Myeloid
Melanoma
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Glioblastoma
Hodgkin Disease
Carcinoma, Renal Cell
Small Cell Lung Carcinoma
Thyroid Neoplasms
Osteosarcoma
Hematologic Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on December 07, 2016