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TerminatedNCT00473616Updated Feb 11, 2011

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

A Phase 1 interventional study of AZD7762 and Irinotecan in Advanced Solid Tumors, Cancer and Advanced Solid Malignancies, sponsored by AstraZeneca. Terminated at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-11.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Why this study was terminated
Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Advanced Solid Tumors
  • Cancer
  • Advanced Solid Malignancies

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Keywords

  • Phase I
  • solid tumors
  • solid malignancies
  • cancer Eligibility
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Poor bone marrow function (not producing enough blood cells)
  • Serious heart conditions
  • Poor liver or kidney function
  • Any prior anthracycline treatment
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    1

    AZD7762 monotherapy followed by AZD7762 + irinotecan

    Drug: AZD7762 · Drug: Irinotecan

Interventions

  • DrugAZD7762

    intravenous infusion

  • DrugIrinotecan

    intravenous injection

    Also known as: Campto®, Camptosar®, irinotecan hydrochloride

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  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

07

Study locations

3 sites
  • Research Site
    Boston, Massachusetts, United States
  • Research Site
    New York, New York, United States
  • Research site
    Nashville, Tennessee, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00473616
Lead sponsor
AstraZeneca
First posted
May 15, 2007
Start date
May 2007
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Feb 11, 2011

Study contacts

Peter Langmuir, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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