- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697060
A Safety and Efficacy Trial of Amplimexon Plus Taxotere in Metastatic Non-Small Cell Lung Cancer
June 22, 2015 updated by: AmpliMed Corporation
A Multicenter, Phase II Trial of the Safety and Efficacy of Amplimexon® (Imexon for Injection) in Combination With Taxotere® (Docetaxel) for Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
Protocol AMP-024 is a Phase 2 study of imexon plus docetaxel for patients with previously treated lung cancer that has spread in the body.
Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for this cancer.
The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle.
The objective of the protocol is to determine if the combination of imexon plus docetaxel is safe and effective.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States
- USC Norris Cotton Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Massachusetts General Hospital
-
-
Texas
-
Dallas, Texas, United States
- Mary Crowley Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with histologically or cytologically confirmed NSCLC.
Subject with metastatic disease (Appendix D) who have received no more than 2 prior chemotherapy regimens for their metastatic disease.
- Adjuvant chemotherapy is considered one prior regimen.
- Immunological and targeted agents such as bevacizumab, erlotinib or gefitinib are considered prior regimens.
- Subjects must have at least one measurable lesion by RECIST criteria (Appendix C). If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD, and if the only target lesion is a single lesion, a cytological or histological confirmation of NSCLC is required.
- Resolution of all chemotherapy or radiotherapy-related toxicities to CTCAE grade 1 or lower, except for stable sensory neuropathy of < grade 2 and/or alopecia.
- Men and women age > 18 years.
- ECOG performance status of 0 - 1 (Appendix E).
- Not pregnant nor lactating.
- If of child bearing potential must be able and agree to use adequate contraception.
Adequate renal function defined by:
- serum creatinine level < 2.0 mg/dL.
- G6PD (quantitative) greater than or equal to the lower limit of normal.
Adequate hematologic function defined by:
- absolute neutrophil count (ANC) >1,500/mm³, and
- platelet count > 100,000/mm³, and
- hemoglobin level > 9 g/dL.
Adequate hepatic function defined by:
- total bilirubin level < ULN, and
- AST and ALT levels < 1.5 x ULN
- Alkaline phosphatase < 2.5x ULN
- Prior brain metastasis are allowed but must have been treated and controlled for > 1 month prior and be off steroids.
- Subjects willing and able to comply with the study protocol for the duration of the study.
- Able to render written informed consent and to follow protocol requirements.
Exclusion Criteria:
- Subjects who have received previous treatment with docetaxel.
- Subjects who have received chemotherapy or radiation treatments within 4 weeks of study treatment start.
- Prior high dose chemotherapy with hematopoietic stem cell rescue within the past two years.
- Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen and/or the medical management of recurrent pleural effusions.
- Subjects with meningeal carcinomatosis.
- Women who are pregnant or breast-feeding, women of child bearing potential (WOCBP) with either a positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) or no pregnancy test; WOCBP unless (1) surgically sterile (hysterectomy, or bilateral oophorectomy) or (2) not using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Severe or uncontrolled intercurrent infection or other illness.
- Significant cardiovascular disease including but not limited to a history of congestive heart failure of > NYHA grade II (Appendix E), unstable angina or a myocardial infarction within the past six months, or serious and uncontrolled arrhythmia.
- Subjects with organ allografts.
- Subjects who have had a prior malignancy, other than carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer unless the prior malignancy was diagnosed and definitively treated > 5 years previously with no subsequent evidence of recurrence.
- Subjects with pre-existing neuropathy > CTCAE Grade 2.
- Subjects with other significant disease or disorders that, in the opinion of the Investigator, would exclude the subject from the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stage 1/2
Imexon plus docetaxel
|
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology.
Time Frame: every 6 weeks
|
every 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival (PFS), as measured from the date of registration to the date of recorded disease progression (PD) or death from any cause.
Time Frame: throughout the study
|
throughout the study
|
Overall survival, as measured from the date of registration to the date of death from any cause.
Time Frame: throughout the study
|
throughout the study
|
Stable disease rate at 2 months.
Time Frame: 2 months
|
2 months
|
Survival at 1-year.
Time Frame: 1 year
|
1 year
|
Duration of response and stable disease.
Time Frame: throughout the study
|
throughout the study
|
Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.)
Time Frame: throughout the study
|
throughout the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Evan Hersh, MD, AmpliMed Corporation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Anticipated)
August 1, 2011
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
June 11, 2008
First Submitted That Met QC Criteria
June 12, 2008
First Posted (Estimate)
June 13, 2008
Study Record Updates
Last Update Posted (Estimate)
June 24, 2015
Last Update Submitted That Met QC Criteria
June 22, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- AMP024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on Imexon + docetaxel
-
AmpliMed CorporationCompletedNeoplasm MetastasisUnited States
-
AmpliMed CorporationCompletedBreast Cancer | Prostate Cancer | Non-small Cell Lung CancerUnited States
-
AmpliMed CorporationCompletedMultiple MyelomaUnited States
-
University of RochesterUniversity of ArizonaCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Lymphoplasmacytic Lymphoma | Diffuse Large B Cell Lymphoma | Small Lymphocytic Lymphoma | Burkitt's LymphomaUnited States
-
AmpliMed CorporationCompletedMalignant MelanomaUnited States
-
AmpliMed CorporationCompletedPancreatic NeoplasmsUnited States
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
AmpliMed CorporationCompletedPancreatic AdenocarcinomaUnited States
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia