Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan

A Phase I Open-label, Multi-center, Dose-escalation and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00473616

Enrollment

Registered

2007-05-15

Start date

2007-05-31

Completion date

2011-01-31

Last updated

2011-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies, Advanced Solid Tumors, Cancer

Keywords

Phase I, solid tumors, solid malignancies, cancer Eligibility

Brief summary

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

Interventions

DRUGAZD7762

intravenous infusion

DRUGIrinotecan

intravenous injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Advanced solid tumors for which standard treatment doesn't exist or is no longer effective. * Must be suitable for treatment with irinotecan * Relatively good overall health other than your cancer

Exclusion criteria

* Poor bone marrow function (not producing enough blood cells) * Serious heart conditions * Poor liver or kidney function * Any prior anthracycline treatment

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan	assessed after each course of treatment

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026