Clinical trials: sponsored by Celgene
Advanced Solid Tumors
A Phase 1 Trial of ABI-011 in Patients With Advanced Solid Tumors or Lymphomas
The purpose of this study is to determine the MTD and/or RP2D of ABI-011 when administered by IV on Day 1, Day 8 and Day 15 with one week of rest for patients with advanced solid tumor malignancies and lymphomas.
- Trial name
- NCT01163071
- Testing
- ABI-011
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Celgene
Myelodysplastic Syndromes
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the…
- Trial name
- NCT01186939
- Testing
- Azacitidine
- Where
- 22 sites in Australia, Bulgaria and 9 more
- Volunteers
- 40 people
- Sponsor
- Celgene
Metastatic Breast Cancer
ABI-008 Trial in Patients With Metastatic Breast Cancer
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given…
- Trial name
- NCT00531271
- Testing
- ABI-008 (nab-docetaxel)
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Celgene
Healthy
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
- Trial name
- NCT01474330
- Testing
- Pomalidomide
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
Japanese Phase 1 Study to Evaluate Tolerated Dose, Safety, and Efficacy of Pomalidomide in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
The purpose of this study is to determine the tolerated dose of pomalidomide and also to evaluate the pharmacokinetics, safety and efficacy of pomalidomide in patients with refractory or relapsed and refractory multiple myeloma.
- Trial name
- NCT01568294
- Testing
- pomalidomide
- Where
- 8 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Celgene
Multiple Myeloma
Pharmacokinetic Study of Thalidomide in Subjects With Multiple Myeloma
Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.
- Trial name
- NCT01937442
- Testing
- Thalidomide Celgene™
- Where
- 7 sites in France, United Kingdom
- Volunteers
- 7 people
- Sponsor
- Celgene
Clinical Pharmacology, Healthy Volunteer Study
A Phase 1 QT Study in Healthy Male Subjects
This is a single-center, randomized, double-blind crossover study with four treatments, four periods and four sequences to investigate the effects of orally administered pomalidomide on QT interval.
- Trial name
- QT/QTc (NCT01986894)
- Testing
- Pomalidomide, Moxifloxacin
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.
- Trial name
- NCT00065351
- Testing
- CC-5013
- Where
- 26 sites in United States
- Volunteers
- 222 people
- Sponsor
- Celgene
Safety and Pharmacokinetics in Healthy Volunteer Subjects
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the…
- Trial name
- AME/FE (NCT01611467)
- Testing
- CC-223
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with…
- Trial name
- NCT00555100
- Testing
- lenalidomide, dexamethasone
- Where
- 5 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Celgene
Clinical Pharmacology, Healthy Volunteer Study
Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males
This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which…
- Trial name
- NCT01835561
- Testing
- Pomalidomide
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Celgene
Multiple Myeloma
Open-label Extended Access Program on Lenalidomide Plus Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma Who Participated in CC-5013-MM021 for at Least 1 Year
CC5013-MM024 is a multicenter, open-label, Extended Access Program (EAP) of lenalidomide plus low dose dexamethasone regimen in Chinese subjects with relapsed or refractory MM who participated in Study CC-5013-MM-021.
- Trial name
- NCT02348528
- Testing
- Lenalidomide, Dexamethasone
- Where
- 11 sites in China
- Volunteers
- 65 people
- Sponsor
- Celgene
Multiple Myeloma
Pomalidomide (POM) in Combination With Low Dose Dexamethasone (LD-Dex) in Patients With Relapsed or Refractory Multiple Myeloma
To provide pomalidomide access to relapsed/refractory multiple myeloma subjects with a likelihood of benefit from the pomalidomide treatment while the medication is not commercially available
- Trial name
- PEXIUS (NCT01632826)
- Testing
- Pomalidomide
- Where
- 42 sites in United States, Canada
- Sponsor
- Celgene
Healthy
2-part Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of CC-220 & Effect of Food on CC-220 in Healthy Subjects
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of CC-220 and to explore the effect of food on the bioavailability of CC-220 in healthy subjects
- Trial name
- NCT01733875
- Testing
- CC-220 0.03 mg, CC-220 0.1 mg, CC-220 0.3 mg
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Celgene
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Study to Evaluate Pharmacokinetics, Food Effect, Safety and Efficacy of Oral Azacitidine
The primary purpose of this study is to evaluate the pharmacokinetics of oral azacitidine when administered once daily as two 150-mg tablets, including the effect of food, and to evaluate the bioavailability of oral azacitidine…
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
- Trial name
- NCT01519011
- Testing
- oral azacitidine
- Where
- 8 sites in United States
- Volunteers
- 34 people
- Sponsor
- Celgene
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
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
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…
- Conditions
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Ovarian Neoplasms, Fallopian Tube Neoplasms
- Trial name
- NCT01478685
- Testing
- CC-486, Carboplatin, ABI-007
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 169 people
- Sponsor
- Celgene
Sarcoidosis
A Phase 2 Study With CC-220 in Skin Sarcoidosis
This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral CC-220 in adult subjects with chronic cutaneous sarcoidosis.
- Trial name
- NCT02192489
- Testing
- CC-220 0.3 mg Daily, CC-220 0.6mg Daily
- Sponsor
- Celgene
Multiple Myeloma
CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.
- Trial name
- NCT00044018
- Testing
- CDC-501
- Where
- 4 sites in United States
- Volunteers
- 102 people
- Sponsor
- Celgene
Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer
Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer
The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each…
- Trial name
- NCT01545947
- Testing
- CC-223, erlotinib, CC-223, oral azacitidine
- Where
- 9 sites in United States, Spain
- Volunteers
- 76 people
- Sponsor
- Celgene
Healthy Volunteers
CC-223 and Ketoconazole Drug-Drug Interaction Study
This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.
- Trial name
- NCT01896323
- Testing
- CC-223, Ketoconazole
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Celgene