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Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

NCT ID: NCT00413686

Last Updated: 2010-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-05-31

Brief Summary

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This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.

Detailed Description

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Conditions

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Solid Tumors

Keywords

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Mixed solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AZD7762 monotherapy followed by AZD7762 + gemcitabine

Group Type EXPERIMENTAL

AZD7762

Intervention Type DRUG

intravenous infusion

Gemcitabine

Intervention Type DRUG

weekly intravenous infusion

Interventions

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AZD7762

intravenous infusion

Intervention Type DRUG

Gemcitabine

weekly intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Gemzar® Gemcitabine HCL

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* ECOG performance status of 0 or 1
* Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

Exclusion Criteria

* Inadequate bone marrow reserve, inadequate liver function or impaired renal function
* Any troponin elevation (above normal range)
* Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction \[MI\])
* Any prior anthracycline treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Peter Langmuir, M.D.

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Baltimore, Maryland, United States

Site Status

Research Site

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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D1040C00002

Identifier Type: -

Identifier Source: org_study_id