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NCT01347788 · ClinicalTrials.gov registry record · Phase 1

Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

A Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01347788: Completed Phase 1 study, sponsored by Massachusetts General Hospital.

NCT01347788 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01347788, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

Primary Outcome

Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.

Interventions

  • DRUG cabozantinib

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2011-04
Est. Completion 2013-05
Phase Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT01347788 record still lists

NCT01347788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

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

NCT01347788 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01347788 about?

NCT01347788 is a clinical study titled "Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer". Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be ...

What is the current status of trial NCT01347788?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-04. Estimated completion is 2013-05.

What interventions are being tested in trial NCT01347788?

The interventions under investigation include: cabozantinib (DRUG).

Who is sponsoring clinical trial NCT01347788?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01347788's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 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 NCT01347788, the US trial registry maintained by the National Library of Medicine. NCT01347788 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.