Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00937664
• Other study ID #: D1040C00008
• Status: Terminated
• Phase: Phase 1
• First received: July 9, 2009
• Last updated: February 4, 2011
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Cancer
• Neoplasms
• Solid Tumors

Intervention

Drug:
• AZD7762
solution, intravenous, weekly
• gemcitabine
intravenous, weekly

Locations

Country	Name	City	State
Japan	Research Site	Minami-ku	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No