NCT00327288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

2.8 years

First QC Date

May 17, 2006

Last Update Submit

June 22, 2015

Conditions

Non-small Cell Lung CancerBreast CancerProstate Cancer

Keywords

Hormone refractory prostate cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Record any objective tumor responses which may occur

    duration of study

Study Arms (1)

A

EXPERIMENTAL

Docetaxel plus imexon

Drug: imexonDrug: docetaxel

Interventions

imexonDRUG

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

Also known as: Amplimexon
A
docetaxelDRUG

IV once every 21 days for duration of study

Also known as: Taxotere
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Active brain metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site 008

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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 lung and prostate cancer. Invest New Drugs. 2010 Oct;28(5):634-40. doi: 10.1007/s10637-009-9273-1. Epub 2009 Jun 6.

    PMID: 19499186RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBreast NeoplasmsProstatic Neoplasms

Interventions

4-imino-1,3-diazabicyclo(3.1.0)hexan-2-oneDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

October 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

US(1)