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A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Relapsed or Refractory Solid Tumors

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Trial Information

A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

Inclusion Criteria:

1. Men and women, 18 years or older at the time of signing the Informed Consent Document

2. Understand and voluntarily sign an ICD prior to any study-related assessments or
procedures are conducted.

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

4. With histological or cytological confirmation of advanced unresectable solid tumors,
including those who have progressed on (or not been able to tolerate) standard
anticancer therapy, or for whom no other effective therapy exists, or for who
declines standard therapy.

5. Consent to screening tumor biopsy (for accessible tumors when appropriate [optional
in Part 1, mandatory in Part 2]).

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

7. The following laboratory values:

- Absolute neutrophil count (ANC) ≥ 1.5 X 10^9/L

- Hemoglobin (Hgb) ≥90 g/L

- Platelets (plt) ≥ 100 x 10^9/L

- Potassium within normal range, or correctable with supplements;

- AST and ALT ≤2.5 x Upper Limit Normal (ULN) or ≤5.0 x ULN if liver tumor is

- Serum total bilirubin ≤ 1.5 x ULN

- Serum creatinine ≤ 1.5 x ULN, or 24-hr clearance ≥ 60ml/min; and

- Negative serum pregnancy test within 7 days before starting study treatment in
females of childbearing potential (FCBP)

8. Part 2 only: Measureable tumor (types to be determined during Part 1)

9. Females of child-bearing potential {defined as a sexually mature women who

- has not undergone a hysterectomy (the surgical removal of the uterus) or
bilateral oophorectomy (the surgical removal of both ovaries) or,

- has not been naturally postmenopausal for at least 24 consecutive months (i.e.,
has had menses at any time during the preceding 24 consecutive months} must

- agree to the use of a physician- approved contraceptive method (oral,
injectable, or implantable hormonal contraceptive ; tubal ligation;
intra-uterine device; barrier contraceptive with spermicide; or
vasectomized partner) while on oral azacitidine and for 3 months following
the last dose of study medication; and

- have a negative serum pregnancy test during screening

10. Male subjects with female partner of childbearing potential must agree to the use of
a physician-approved contraceptive method throughout the course of the study to avoid
fathering a child during the course of the study and for 6 months following the last
dose of oral azacitidine.

Exclusion Criteria:

1. Any significant medical condition, laboratory abnormality, or psychiatric illness
that would prevent the subject from participating in the study.

2. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study.

3. Any condition that confounds the ability to interpret data from the study.

4. Symptomatic central nervous system metastases. Subjects with brain metastases that
have been previously treated and are stable for 6 weeks are allowed.

5. Known acute or chronic pancreatitis.

6. Any peripheral neuropathy ≥ NCI CTCAE grade 2.

7. Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management.

8. Impaired ability to swallow oral medication.

9. Unstable angina, significant cardiac arrythmia, or New York Heart Association (NYHA)
class 3 or 4 congestive heart failure.

10. Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half
lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not
recovered from side effects of such therapy. (except alopecia).

11. Major surgery ≤ 2 weeks prior to starting a study drug or who have not recovered from
side effects of such therapy.

12. Pregnant or breast feeding.

13. Known Human Immunodeficiency Virus (HIV) infection.

14. Known chronic hepatitis B or C virus (HBV/HCV) infection, unless this is a
comorbidity in subjects with HCV.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events

Outcome Description:

Number of participants with adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, Version 4.0.

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Jorge F. DiMartino, M.D., Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

January 2014

Related Keywords:

  • Relapsed or Refractory Solid Tumors
  • Relapsed or Refractory Solid Tumors
  • Neoplasms



Indiana UniversityIndianapolis, Indiana  46202
Karmanos Cancer InstituteDetroit, Michigan  48201
STARTSan Antonio, Texas  78229
Virginia G. Piper Cancer Center at Scottsdale HealthcareScottsdale, Arizona  85258
Sarah Cannon Research - Drug Development UnitNashville, Tennessee  37203
UCSF-Helen Diller Family Comprehensive Cancer Care CenterSan Francisco, California  94115
Greenville Hospital System, Institute for Translational Oncology ResearchGreenville, South Carolina  29605