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
1 other identifier
interventional
169
4 countries
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2011
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedStudy Start
First participant enrolled
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2015
CompletedNovember 12, 2019
November 1, 2019
4 years
November 21, 2011
November 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
An adverse event (AE) is 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.
Up to 3 years
Secondary Outcomes (11)
Cmax
Up to 30 days
AUC
Up to 30 days
Tmax
Up to 30 days
T1/2
Up to 30 days
CL/F
Up to 30 days
- +6 more secondary outcomes
Study Arms (3)
Arm A: CC-486 plus Carboplatin
EXPERIMENTALCC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability. Carboplatin will be given by intravenous (IV) infusion once every 21 Days at a dosage of AUC x 4.
Arm B: CC-486 plus ABI-007
EXPERIMENTALCC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability ABI-007 will be administered by intravenous (IV) infusion on two of every three weeks at a dosage of 100 mg/m\^2
Arm C: CC-486
EXPERIMENTALCC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability
Interventions
CC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability
Carboplatin will be given by intravenous (IV) infusion once every 21 Days at a dosage of AUC x 4.
ABI-007 will be administered by intravenous (IV) infusion on two of every three weeks at a dosage of 100 mg/m\^2
Eligibility Criteria
You may qualify if:
- 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:
- 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 present;
- 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)
- +25 more criteria
You may not qualify if:
- 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.
- Impaired ability to swallow oral medication.
- Unstable angina, significant cardiac arrythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
- 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).
- Major surgery ≤ 2 weeks prior to starting a study drug or who have not recovered from side effects of such therapy.
- Pregnant or breast feeding.
- Known Human Immunodeficiency Virus (HIV) infection.
- Known chronic hepatitis B or C virus (HBV/HCV) infection, unless this is a comorbidity in subjects with HCV.
- Liver metastases with serum albumin \< 3 g/dL.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (13)
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, 85258, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2014, United States
Greenville Hospital
Greenville, South Carolina, 29605, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37205, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Centre Georges Francois Leclerc
Dijon, 21079, France
Institut Curie
Paris, 75005, France
The Netherlands Cancer Instiute Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066 CX, Netherlands
Erasmus Medical Center
Rotterdam, 3015 CN, Netherlands
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
LoRusso P, et al. A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors . Presented at 25th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, Boston, MA. Abstract No. A120.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gordan Bray, M.D., Ph.D
Celgene
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2011
First Posted
November 23, 2011
Study Start
November 29, 2011
Primary Completion
November 17, 2015
Study Completion
November 17, 2015
Last Updated
November 12, 2019
Record last verified: 2019-11