Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937664

Enrollment

Registered

2009-07-13

Start date

2009-07-31

Completion date

2011-02-28

Last updated

2011-02-07

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

Conditions

Advanced Solid Malignancies, Cancer, Solid Tumors

Keywords

Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, CHK inhibitor, Japanese

Brief summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Interventions

DRUGAZD7762

solution, intravenous, weekly

DRUGgemcitabine

intravenous, weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective. * Must be suitable for treatment with gemcitabine * Relatively good overall health other than cancer

Exclusion criteria

* Poor bone marrow function (not producing enough blood cells). * Poor liver or kidney function. * Serious heart conditions

Design outcomes

Primary

Measure	Time frame
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram	Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2

Secondary

Measure	Time frame
Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST)	Every 2-3 cycles
Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine	According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026