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TerminatedNCT01112397Updated Jul 22, 2013

Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

A Phase 1 interventional study of AZD1480 in 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 2013-07-22.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Why this study was terminated
Decision to stop development of AZD1480
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.

02

Conditions studied

  • Solid Malignancies

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Keywords

  • Jak2
  • cancer
  • jak 1
  • stat 3
  • Phase 1
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 72 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase
  • ECOG Performance Status 0-1
  • Evidence of post-menopausal status in females or males willing to use barrier contraception

Exclusion criteria

Exclusion Criteria:

  • Prior therapy with any JAK2 medications
  • Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD
  • Eye disease of the cornea
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    1

    AZD1480 until Maximum Tolerated Dose (MTD) is reached

    Drug: AZD1480

  • Experimental
    2

    AZD1480 dose expansion of MTD

    Drug: AZD1480

Interventions

  • DrugAZD1480

    continuous daily oral capsule

06

What researchers measure

Primary outcomes

  1. Safety and tolerability as assessed by Adverse events, vital signs, ECGs, Pulmonary Function Tests (DLco, FEV, FVC, Oxygen saturation) and laboratory data (chemistry, hematology and Urinalysis)

    Time frame: Information will be collected from the time the informed consent is signed, throughout the study

Secondary outcomes

  1. Evaluation of the pharmacokinetics of AZD1480

    Time frame: During all cycles

07

Study locations

3 sites
  • Research Site
    Aurora, Colorado, United States
  • Research Site
    Detroit, Michigan, United States
  • Research Site
    Philadelphia, Pennsylvania, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2010, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2010
First posted
Apr 28, 2010
Start
Apr 2010
Primary completionActual
Sep 2012
CompletionActual
Sep 2012
Last update
Jul 22, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01112397
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Apr 28, 2010
Start date
Apr 2010
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Jul 22, 2013

Study contacts

Gregory Curt, MD
study chair · AstraZeneca

Oversight

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

Not currently enrolling

This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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