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NCT00600496 · ClinicalTrials.gov registry record · Phase 1

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 1
Development phase
140
Enrollment target
4
Study locations

NCT00600496: Active Phase 1 study of Breast Cancer and Lung Cancer, sponsored by AstraZeneca.

NCT00600496 is a Phase 1 study of Breast Cancer and Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 140 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00600496, a Phase 1 study of Breast Cancer and Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
140 participants
Enrollment target
4
Study locations

Study Summary

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies

Primary Outcome

Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.

Interventions

  • DRUG Docetaxel
  • DRUG Dacarbazine
  • DRUG Temsirolimus
  • DRUG Erlotinib
  • DRUG AZD6244

Study Locations (4)

Michigan

  • Research Site - Detroit

Pennsylvania

  • Research Site - Philadelphia

Tennessee

  • Research Site - Nashville

Texas

  • Research Site - Houston

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2007-12-14
Est. Completion 2025-12-31
Phase Phase 1
AstraZeneca

1,285 total trials

What the registry record for NCT00600496 still lists

NCT00600496 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).

The record links to 8 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.

NCT00600496 reports a single indexed study location in Michigan, Pennsylvania, Tennessee.

Frequently Asked Questions

What is clinical trial NCT00600496 about?

NCT00600496 is a clinical study titled "A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)". This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies ...

What is the current status of trial NCT00600496?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2007-12-14. Estimated completion is 2025-12-31.

What conditions does trial NCT00600496 study?

This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Melanoma, Colon Cancer, Breast Neoplasms.

What interventions are being tested in trial NCT00600496?

The interventions under investigation include: Docetaxel (DRUG), Dacarbazine (DRUG), Temsirolimus (DRUG), Erlotinib (DRUG), AZD6244 (DRUG).

Who is sponsoring clinical trial NCT00600496?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00600496 being conducted?

This trial has 4 study locations across Michigan, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00600496's enrollment target sits among peer trials

140 464th of 1224 higher than 757 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00600496, the US trial registry maintained by the National Library of Medicine. NCT00600496 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.