A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Sub… (NCT01478685) | Clinical Trial Compass
CompletedPhase 1
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
United States169 participantsStarted 2011-11-29
Plain-language summary
The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women, 18 years or older at the time of signing the Informed Consent Document (ICD).
✓. Understand and voluntarily sign an ICD prior to any study-related assessments or procedures are conducted.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. 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.
✓. Consent to screening tumor biopsy (for accessible tumors when appropriate \[optional in Part 1, mandatory in Part 2\]).
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
✓. The following laboratory values:
✓. Females of child-bearing potential {defined as a sexually mature women who
Exclusion criteria
✕. 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.
✕. Symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 6 weeks are allowed.
✕. Known acute or chronic pancreatitis.
✕. Any peripheral neuropathy ≥ NCI CTCAE grade 2.
✕. Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management.