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NCT01469052 · ClinicalTrials.gov registry record · Phase 1

First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors

A Phase 1 study, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT01469052: Completed Phase 1 study, sponsored by Pfizer.

NCT01469052 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01469052, a Phase 1 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

Primary Outcome

MTD is defined as the dose level at which "no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD)." DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.

Interventions

  • DRUG AG-013736

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2002-11
Est. Completion 2004-08
Phase Phase 1
Pfizer

1,845 total trials

What the finished NCT01469052 record still lists

NCT01469052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which AG-013736 is the first listed.

NCT01469052 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01469052 about?

NCT01469052 is a clinical study titled "First In Human, Phase 1 Study of AG013736 In Patients With Solid Tumors". The purpose of the study was to characterize the safety of investigational agent AG-013736, in patients with solid tumors in this First In Human trial.

What is the current status of trial NCT01469052?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2002-11. Estimated completion is 2004-08.

What interventions are being tested in trial NCT01469052?

The interventions under investigation include: AG-013736 (DRUG).

Who is sponsoring clinical trial NCT01469052?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01469052's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01469052, the US trial registry maintained by the National Library of Medicine. NCT01469052 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.