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NCT01048723 · ClinicalTrials.gov registry record · Phase 2

Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas

A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Terminated
Registry status
Phase 2
Development phase
2
Enrollment target

NCT01048723: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT01048723 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01048723, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

TERMINATED
Registry status
Phase 2
Development phase
2 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if RAD001 is safe and effective in patients with this condition. The study drug, RAD001, is made by Novartis Pharmaceuticals Corporation.

Primary Outcome

PD markers of RAD001 on downstream signaling pathways in patients with sarcomas: p70S6K, S6-RP, P-AKT, cleaved PARP and PCNA by Western blot, quantitative multiplex assays and immunohistochemical studies measured pre and post the 2 week treatment of RAD001. Patients were to be separated into two groups, responders and non responders based on PD results and downstream up regulation of the referenced pathways. Mean fractional inhibition of each PD marker for the responding and non-responding group

Interventions

  • DRUG RAD001

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2010-01
Est. Completion 2011-10
Phase Phase 2

Why NCT01048723 stopped before completion

NCT01048723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which RAD001 is the first listed.

NCT01048723 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01048723 about?

NCT01048723 is a clinical study titled "Study of RAD001 in Soft Tissue Extremity and/or Retroperitoneal Sarcomas". The goal of this clinical research study is to learn if the study drug RAD001 can stop or slow the growth of resectable soft tissue sarcoma. The patient's physical state, their symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team dec...

What is the current status of trial NCT01048723?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2010-01. Estimated completion is 2011-10.

What interventions are being tested in trial NCT01048723?

The interventions under investigation include: RAD001 (DRUG).

Who is sponsoring clinical trial NCT01048723?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01048723's enrollment target sits among peer trials

2 2001st of 2000 the lowest 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 NCT01048723, the US trial registry maintained by the National Library of Medicine. NCT01048723 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.