Carcinoma, Non-Small-Cell LungPhase 2NCT00697060
A Safety and Efficacy Trial of Amplimexon Plus Taxotere in Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Imexon + docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by AmpliMed Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Imexon + docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts
Mary Crowley Research Center
Dallas, Texas
USC Norris Cotton Cancer Center
Los Angeles, California
About this study
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)
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Imexon + docetaxel
- Keywords
- Metastatic, Previously treated
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imexon + docetaxelDrug
Also called Amplimexon, Taxotere
Imexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1
| Study group | Role | What they receive |
|---|---|---|
| Stage 1/2 | Experimental | Imexon plus docetaxel Receives: Drug: Imexon + docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology.
Measured: every 6 weeks
Secondary outcomes (6)
Progression-free survival (PFS), as measured from the date of registration to the date of recorded disease progression (PD) or death from any cause.
Measured: throughout the study
Overall survival, as measured from the date of registration to the date of death from any cause.
Measured: throughout the study
Stable disease rate at 2 months.
Measured: 2 months
Survival at 1-year.
Measured: 1 year
Duration of response and stable disease.
Measured: throughout the study
Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.)
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Study cancelled prior to start due to change in company priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmpliMed Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evan Hersh, MD, Study director, AmpliMed Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697060
- Sponsor's protocol ID
- AMP024
- Status last verified
- Jun 2015
- First submitted
- 11 Jun 2008
- Last updated
- 24 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00697060
- Acronym / sponsor ID
- AMP024
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Metastatic, Previously treated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled prior to start due to change in company priorities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 1/2 | Experimental | Drug: Imexon + docetaxelImexon plus docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imexon + docetaxelAlso: Amplimexon, TaxotereImexon at 1300 mg/m2 days 1-5 Docetaxel at 75 mg/m2 day 1 | Drug | Stage 1/2 |
Primary outcome
Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology.
Time frame: every 6 weeks
6 secondary outcomes
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
Overall survival, as measured from the date of registration to the date of death from any cause.
Time frame: throughout the study
Stable disease rate at 2 months.
Time frame: 2 months
Survival at 1-year.
Time frame: 1 year
Duration of response and stable disease.
Time frame: throughout the study
Safety parameters (AEs, laboratory parameters, concomitant medication, study drug exposure, drug related toxicities, etc.)
Time frame: throughout the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Hersh, MD study director
AmpliMed Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imexon + docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by AmpliMed Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rates (CR + PR) in subjects with measurable disease will be determined by RECIST methodology. (time frame: every 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.