A Safety and Efficacy Trial of Amplimexon Plus Taxotere in Metastatic Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697060
Recruitment Status : Withdrawn (Study cancelled prior to start due to change in company priorities.)
First Posted : June 13, 2008
Last Update Posted : June 24, 2015
Information provided by:
AmpliMed Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Imexon + docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : August 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stage 1/2
Imexon plus docetaxel
Drug: Imexon + docetaxel
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
Other Names:
  • Amplimexon
  • Taxotere

Primary Outcome Measures :
  1. Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology. [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. Overall survival, as measured from the date of registration to the date of death from any cause. [ Time Frame: throughout the study ]
  3. Stable disease rate at 2 months. [ Time Frame: 2 months ]
  4. Survival at 1-year. [ Time Frame: 1 year ]
  5. Duration of response and stable disease. [ Time Frame: throughout the study ]
  6. Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.) [ Time Frame: throughout the study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects with histologically or cytologically confirmed NSCLC.
  2. 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.
  3. 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.
  4. 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.
  5. Men and women age > 18 years.
  6. ECOG performance status of 0 - 1 (Appendix E).
  7. Not pregnant nor lactating.
  8. If of child bearing potential must be able and agree to use adequate contraception.
  9. Adequate renal function defined by:

    • serum creatinine level < 2.0 mg/dL.
  10. G6PD (quantitative) greater than or equal to the lower limit of normal.
  11. Adequate hematologic function defined by:

    • absolute neutrophil count (ANC) >1,500/mm³, and
    • platelet count > 100,000/mm³, and
    • hemoglobin level > 9 g/dL.
  12. Adequate hepatic function defined by:

    • total bilirubin level < ULN, and
    • AST and ALT levels < 1.5 x ULN
    • Alkaline phosphatase < 2.5x ULN
  13. Prior brain metastasis are allowed but must have been treated and controlled for > 1 month prior and be off steroids.
  14. Subjects willing and able to comply with the study protocol for the duration of the study.
  15. Able to render written informed consent and to follow protocol requirements.

Exclusion Criteria:

  1. Subjects who have received previous treatment with docetaxel.
  2. Subjects who have received chemotherapy or radiation treatments within 4 weeks of study treatment start.
  3. Prior high dose chemotherapy with hematopoietic stem cell rescue within the past two years.
  4. 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.
  5. Subjects with meningeal carcinomatosis.
  6. 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.
  7. Severe or uncontrolled intercurrent infection or other illness.
  8. 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.
  9. Subjects with organ allografts.
  10. 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.
  11. Subjects with pre-existing neuropathy > CTCAE Grade 2.
  12. Subjects with other significant disease or disorders that, in the opinion of the Investigator, would exclude the subject from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697060

United States, California
USC Norris Cotton Cancer Center
Los Angeles, California, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, Texas
Mary Crowley Research Center
Dallas, Texas, United States
Sponsors and Collaborators
AmpliMed Corporation
Study Director: Evan Hersh, MD AmpliMed Corporation

Responsible Party: Evan Hersh, AmpliMed Identifier: NCT00697060     History of Changes
Other Study ID Numbers: AMP024
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015

Keywords provided by AmpliMed Corporation:
Previously treated

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action