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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00413686
First received: December 19, 2006
Last updated: December 3, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Solid Tumors
Drug: AZD7762
Drug: Gemcitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine [ Time Frame: Assessed after each course of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: December 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + gemcitabine
Drug: AZD7762
intravenous infusion
Drug: Gemcitabine
weekly intravenous infusion
Other Names:
  • Gemzar®
  • Gemcitabine HCL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00413686     History of Changes
Other Study ID Numbers: D1040C00002
Study First Received: December 19, 2006
Last Updated: December 3, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Mixed solid tumors

Additional relevant MeSH terms:
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 17, 2014