Phase I Single Ascending Dose/Multiple Ascending Dose in Patients Treated With AZD7762 and Irinotecan

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:
NCT00473616
First received: May 14, 2007
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

This is an open-label, multi-center, dose-escalation and safety expansion, Phase I study to evaluate the safety, tolerability, and pharmacokinectics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with irinotecan. The study is sponsored by AstraZeneca.


Condition Intervention Phase
Advanced Solid Tumors
Cancer
Advanced Solid Malignancies
Drug: AZD7762
Drug: Irinotecan
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 and Safety Expansion Study to Assess Safety, Tolerability, and Pharmacokinectics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose of Irinotecan in Patients With Advanced Solid Malignancies.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The primary objective of this study is to assess the safety and tolerability of AZD7762 alone and in combination with Irinotecan [ 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 ]

Estimated Enrollment: 60
Study Start Date: May 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + irinotecan
Drug: AZD7762
intravenous infusion
Drug: Irinotecan
intravenous injection
Other Names:
  • Campto®
  • Camptosar®
  • irinotecan hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
  • Must be suitable for treatment with irinotecan
  • Relatively good overall health other than your cancer

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells)
  • Serious heart conditions
  • Poor liver or kidney function
  • Any prior anthracycline treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00473616

Locations
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research site
Nashville, Tennessee, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Peter Langmuir, MD AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00473616     History of Changes
Other Study ID Numbers: D1040C00004
Study First Received: May 14, 2007
Last Updated: February 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
solid tumors
solid malignancies
cancer Eligibility

Additional relevant MeSH terms:
Neoplasms
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014