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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT00473616
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Solid Malignancies
  • Advanced Solid Tumors
  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD7762 — DRUG
    intravenous infusion
  • Irinotecan — DRUG
    intravenous injection

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Feb 2011
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    AZD7762 monotherapy followed by AZD7762 + irinotecan

Primary Outcome Measure

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 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts--
Research SiteNew YorkNew York--
Research siteNashvilleTennessee--

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