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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00937664
First received: July 9, 2009
Last updated: February 4, 2011
Last verified: February 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00937664     History of Changes
Other Study ID Numbers: D1040C00008
Study First Received: July 9, 2009
Last Updated: February 4, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 16, 2014