A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies

AstraZeneca1 site in 1 country42 target enrollmentDecember 2006

ConditionsSolid Tumors

InterventionsAZD7762 Gemcitabine

DrugsAZD7762 Gemcitabine

Overview

Phase: Phase 1
Intervention: AZD7762
Conditions: Solid Tumors
Sponsor: AstraZeneca
Enrollment: 42
Locations: 1
Primary Endpoint: To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

May 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

1

AZD7762 monotherapy followed by AZD7762 + gemcitabine

Intervention: AZD7762

1

AZD7762 monotherapy followed by AZD7762 + gemcitabine

Intervention: Gemcitabine

Outcomes

Primary Outcomes

To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine

Time Frame: Assessed after each course of treatment

Secondary Outcomes

To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.(Assessed after each course of treatment)