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

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: AZD7762; Drug: Gemcitabine

• Registration Number: NCT00413686
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-20
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD7762	AZD7762 monotherapy followed by AZD7762 + gemcitabine
1	Gemcitabine	AZD7762 monotherapy followed by AZD7762 + gemcitabine

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine	Assessed after each course of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Detroit, Michigan, United States