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NCT01687673 · ClinicalTrials.gov registry record · Phase 2

Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
29
Enrollment target

NCT01687673: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT01687673 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 29 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01687673, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
29 participants
Enrollment target

Study Summary

This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of the combination of temsirolimus is 10 mg IV weekly plus sorafenib 200 mg (oral, twice daily).

Primary Outcome

Median TTP will be calculated in months from date of first dose of protocol therapy to date of removal from study for progression, where progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter of the target lesions (SLD), taking as reference the smallest sum of the SLD recorded since the treatment started and minimum 5 millimeter (mm) increase over the nadir, or the appearance of one or more new les

Interventions

  • DRUG Temsirolimus
  • DRUG Sorafenib:

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2012-10-05
Est. Completion 2020-01-09
Phase Phase 2

What the finished NCT01687673 record still lists

NCT01687673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 2 interventions - of which Temsirolimus is the first listed.

NCT01687673 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01687673 about?

NCT01687673 is a clinical study titled "Phase II Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma". This Phase II trial is being developed following the completion of a Phase I study of the combination of temsirolimus and sorafenib in 25 first-line therapy patients with advanced hepatocellular carcinoma (December 2009 through April 2012). The maximum tolerated dose (MTD) and recommended phase II d...

What is the current status of trial NCT01687673?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2012-10-05. Estimated completion is 2020-01-09.

What interventions are being tested in trial NCT01687673?

The interventions under investigation include: Temsirolimus (DRUG), Sorafenib: (DRUG).

Who is sponsoring clinical trial NCT01687673?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01687673's enrollment target sits among peer trials

29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01687673, the US trial registry maintained by the National Library of Medicine. NCT01687673 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.