Breast Cancer Clinical Trial
Official title:
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
Verified date | June 2015 |
Source | AmpliMed Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. 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 the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated. - Prior treatment; at least one prior regimen required. - Able to perform the activities of daily living. - Off prior cancer therapy for at least 4 weeks. - If female neither pregnant nor nursing. - Willing to use contraceptives to prevent pregnancy. - No other serious illnesses. - No other active malignancy. - No serious infections. - No other current drug therapy for the cancer. - Blood counts and blood chemistries in or near normal range. - Prior radiation is permitted. Exclusion Criteria: - Active brain metastases. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigational Site 008 | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
AmpliMed Corporation |
United States,
Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with docetaxel for the treatment of patients with advanced breast, non-small cell lu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the tolerability | duration of study | Yes | |
Primary | determine the maximally tolerated dose (MTD) | duration of study | Yes | |
Primary | determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel | duration of study | Yes | |
Primary | correlate changes in plasma glutathione (GSH) levels with imexon dose levels | cycle 1 | No | |
Secondary | Record any objective tumor responses which may occur | duration of study | No |
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