NCT01478685

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-11-29
• Primary completion: 2015-11-17
• Completion: 2015-11-17
• First posted: 2011-11-23
• Last updated: 2019-11-12

Locations

13 sites across 4 countries: United States, France, Netherlands, Spain