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Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies

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ClinicalTrials.gov Identifier: NCT00413686
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : December 6, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: AZD7762 Drug: Gemcitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies
Study Start Date : December 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + gemcitabine
 Drug: AZD7762
intravenous infusion
Drug: Gemcitabine
weekly intravenous infusion
Other Names:
  • Gemzar®
  • Gemcitabine HCL


Outcome Measures
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Primary Outcome Measures :
  1. To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine [ Time Frame: Assessed after each course of treatment ]

Secondary Outcome Measures :
  1. To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. [ Time Frame: Assessed after each course of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • ECOG performance status of 0 or 1
  • Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.

Exclusion Criteria:

  • Inadequate bone marrow reserve, inadequate liver function or impaired renal function
  • Any troponin elevation (above normal range)
  • Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction [MI])
  • Any prior anthracycline treatment
Contacts and Locations
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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): NCT00413686


Locations
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Peter Langmuir, M.D. AstraZeneca
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00413686     History of Changes
Other Study ID Numbers: D1040C00002
First Posted: December 20, 2006    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Mixed solid tumors

Additional relevant MeSH terms:
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