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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

NCT01478685 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2019-11-12

No results posted yet for this study

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.

Conditions

  • Urinary Bladder Neoplasms
  • Carcinoma, Transitional Cell
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Pancreatic Ductal
  • Tumor Virus Infections

Interventions

DRUG

CC-486

CC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability

DRUG

Carboplatin

Carboplatin will be given by intravenous (IV) infusion once every 21 Days at a dosage of AUC x 4.

DRUG

ABI-007

ABI-007 will be administered by intravenous (IV) infusion on two of every three weeks at a dosage of 100 mg/m\^2

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Gordan Bray, M.D., Ph.D · Celgene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-29
Primary Completion
2015-11-17
Completion
2015-11-17

Countries

  • United States
  • France
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01478685 on ClinicalTrials.gov