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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: AZD7762; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00413686

D1040C00002

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

AZD7762 monotherapy followed by AZD7762 + gemcitabine

Treatment:

Drug: Gemcitabine

Drug: AZD7762