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Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

This study has been terminated.
(Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00937664
First Posted: July 13, 2009
Last Update Posted: February 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Cancer Solid Tumors Advanced Solid Malignancies Drug: AZD7762 Drug: gemcitabine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram [ Time Frame: 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 Outcome Measures:
  • Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine [ Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1 ]
  • Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 2-3 cycles ]

Enrollment: 24
Study Start Date: July 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AZD7762 + gemcitabine
AZD7762 administered alone and in combination with gemcitabine
Drug: AZD7762
solution, intravenous, weekly
Drug: gemcitabine
intravenous, weekly
Other Name: Gemzar

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937664


Locations
Japan
Research Site
Minami-ku, Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Peter Langmuir, MD AstraZeneca
Principal Investigator: Takashi Seto, MD, PhD National Hospital Organization Kyushu Cancer Center
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00937664     History of Changes
Other Study ID Numbers: D1040C00008
First Submitted: July 9, 2009
First Posted: July 13, 2009
Last Update Posted: February 7, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Phase I
cancer
solid tumors
advanced solid malignancies
dose escalation
combination treatment
CHK inhibitor
Japanese

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs