Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients
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.
Checked against the public recordLast updated Jun 24, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AmpliMed Corporation
- Interventions being studied
- Drug: imexon; Drug: docetaxel
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Investigational Site 008Houston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 24, 2015. Always confirm current availability with the study team.