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CompletedNCT00413686Updated Dec 6, 2010

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

A Phase 1 interventional study of AZD7762 and Gemcitabine in Solid Tumors, sponsored by AstraZeneca. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-06.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors

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Keywords

  • Mixed solid tumors
03

In context

Neoplasms

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

This study's enrollment of 42 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

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.

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Who can participate

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

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

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
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Study design

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

Study arms

  • Experimental
    1

    AZD7762 monotherapy followed by AZD7762 + gemcitabine

    Drug: AZD7762 · Drug: Gemcitabine

Interventions

  • DrugAZD7762

    intravenous infusion

  • DrugGemcitabine

    weekly intravenous infusion

    Also known as: Gemzar®, Gemcitabine HCL

06

What researchers measure

Primary outcomes

  1. To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine

    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

2 sites
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    Detroit, Michigan, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00413686
Lead sponsor
AstraZeneca
First posted
Dec 20, 2006
Start date
Dec 2006
Primary completion
May 2010
Completion
May 2010
Last update
Dec 6, 2010

Study contacts

Peter Langmuir, M.D.
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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