Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327288

Enrollment

Registered

2006-05-18

Start date

2005-10-31

Completion date

2008-07-31

Last updated

2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer

Keywords

Hormone refractory prostate cancer

Brief summary

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.

Interventions

DRUGimexon

IV variable dosages, days 1-5 every 21 days for duration of study

DRUGdocetaxel

IV once every 21 days for duration of study

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Determine the tolerability	duration of study
determine the maximally tolerated dose (MTD)	duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel	duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels	cycle 1

Secondary

Measure	Time frame
Record any objective tumor responses which may occur	duration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026