Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
This study is currently recruiting participants.
Verified February 2013 by Celgene Corporation
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01177397
First received: August 5, 2010
Last updated: February 25, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma Diffuse Large B-Cell Lymphoma Glioblastoma Multiforme Hepatocellular Carcinoma Non-Small Cell Lung Cancer Neuroendocrine Tumors of Non-Pancreatic Origin Hormone Receptor-Positive Breast Cancer |
Drug: CC-223 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma. |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Safety [ Time Frame: From the time of informed consent, throughout dosing period and for 21 days after the last dose of CC-223 ] [ Designated as safety issue: Yes ]To determine the safety profile and dose-limiting toxicity of CC-223 using NCI CTCAE v4.
- Pharmacokinetics [ Time Frame: Throughout the first cycle (30 days) through to the first day of Cycle 2. ] [ Designated as safety issue: No ]Standard variables (eg. Cmax, AUC, half-life) to define the PK profile for single and multiple doses of oral CC-223.
Secondary Outcome Measures:
- Pharmacodynamics [ Time Frame: Throughout the first cycle (30 days) through to the first day of Cycle 2. ] [ Designated as safety issue: No ]Phosphorylation inhibition changes by levels of S6, 4EBP (for mTORC1) and AKT (for mTORC2) in circulating granulocytes, and tumor tissue (when available).
- Efficacy [ Time Frame: Every 2-3 months until proof of tumor progression ] [ Designated as safety issue: No ]Tumor response rates using appropriate objective criteria for various malignancies
| Estimated Enrollment: | 230 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CC-223
All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.
|
Drug: CC-223
Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (actively recruiting) Optimal dose is administered in 28 day cycles until disease progression. |
Detailed Description:
Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple myeloma
- Patients have not tolerated or progressed on standard therapy, and no further standard therapy is available
- Archival and screening tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy)
- Adequate organ function
Exclusion Criteria:
- Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug
- Symptomatic brain metastases (prior Rx and stable metastases are OK)
- Acute or chronic liver or renal disease or pancreatitis
- Diarrhea ≥ Grade 2, impaired GI absorption
- Impaired cardiac function
- Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5%
- Peripheral neuropathy ≥ Grade 2
- Pulmonary fibrosis
- Known HIV infection
- Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC
- Pregnant, inadequate contraception
- Most concurrent second malignancies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177397
Contacts
| Contact: Wayne R. Hull | 908-673-9727 | whull@celgene.com |
Locations
| United States, California | |
| UCLA Neuro-Oncology Program | Recruiting |
| Los Angeles, California, United States, 90095-1769 | |
| Contact: Emese Filka 310-794-3521 EFilka@mednet.ucla.edu | |
| Cedars-Sinai Medical Center-Samuel Oschin Comprehensive Cancer Institute | Active, not recruiting |
| Los Angeles, California, United States, 90048 | |
| University of California at San Francisco | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Paula Fiermonte, RN 415-885-7605 pfiermonte@medicine.ucsf.edu | |
| Principal Investigator: Pamela Munster, MD | |
| United States, Florida | |
| Moffitt Cancer Center & Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Jennifer Cooksey, BS, CCRP 813-745-4740 Jennifer.Cooksey@moffitt.org | |
| United States, Minnesota | |
| Mayo Clinic | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mayo Clinic Clinical Trials Office 507-538-7623 | |
| United States, Montana | |
| Billings Clinic | Terminated |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| John Theurer Cancer Center at Hackensack University | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Danielle Schillen, R.N. 201-336-8849 dschillen@humed.com | |
| United States, New York | |
| NYU Cancer Institute | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Nicholas B. Shuman, MSN, RN 212-263-9091 Nicholas.Shuman@nyumc.org | |
| United States, Tennessee | |
| Sarah Cannon Research Institute (SCRI) | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Vicky D. Weikal 615-524-4052 Vicky.Weikal@scresearch.net | |
| Principal Investigator: Johanna Bendell, M.D | |
| United States, Texas | |
| Mary Crowley Cancer Research Centers | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Meghan Degele 972-566-3062 mdegele@marycrowley.org | |
| France | |
| Institut Claudius Régaud | Recruiting |
| Toulouse Cedex, France, 31052 | |
| Contact: Jean-Pierre Delord +33567222567 delord.jean-pierre@claudiusregaud.fr | |
| Institut Gustave Roussy, Dept. of Medicine | Recruiting |
| Villejuif Cedex, France, 94800 | |
| Contact: Natacha Colin +33142114952 natacha.colin@igr.fr | |
| Spain | |
| Hospital Universitario de Salamanca | Recruiting |
| Salamanca, Spain, 37007 | |
| Contact: Irene Real +34923291384 ireal@usal.es | |
| Servicio de Oncologia Medica Sala de Investigación | Recruiting |
| Seville, Spain, 41013 | |
| Contact: Ana Calderon +0034955013068 ana.calderon.exts@juntadeandalucia.es | |
| United Kingdom | |
| University College London Hospitals NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, NW1 2BU | |
| Contact: Alan Sahin +44 (0) 845 1555 000 ext 76043 Alan.Sahin@uclh.nhs.uk | |
| Sarah Cannon Research Institute | Not yet recruiting |
| London, United Kingdom, W1G 6AD | |
| Contact: Janet Shadare +44 (0) 203 219 5220 Janet.Shadare@HCAHealthcare.co.uk | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Kristen Hege, M.D. | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT01177397 History of Changes |
| Other Study ID Numbers: | CC-223-ST-001 |
| Study First Received: | August 5, 2010 |
| Last Updated: | February 25, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé France: Committee for the Protection of Personnes France: Conseil National de l'Ordre des Médecins France: Direction Générale de la Santé France: French Data Protection Authority France: Haute Autorité de Santé Transparency Commission France: Institutional Ethical Committee France: Agence Nationale de Sécurité du Médicament et des produits de santé France: Ministry of Health France: Ministère de l'Enseignement supérieur et de la Recherche France: National Consultative Ethics Committee for Health and Life Sciences France: The Commission nationale de l’informatique et des libertés Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica Spain: Departament de Salut de la Generalitat de Catalunya Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines United States: Food and Drug Administration United States: Institutional Review Board United Kingdom: Department of Health United Kingdom: Food Standards Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: National Institute for Health Research United Kingdom: Research Councils UK United Kingdom: Research Ethics Committee |
Keywords provided by Celgene Corporation:
|
Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma, Multiple Myeloma |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Glioblastoma Lung Neoplasms Lymphoma Lymphoma, Non-Hodgkin Multiple Myeloma Neoplasms, Plasma Cell Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neuroendocrine Tumors Carcinoma, Hepatocellular Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
ClinicalTrials.gov processed this record on June 18, 2013