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NCT01158274 · ClinicalTrials.gov registry record · Phase 1

RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01158274: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01158274 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01158274, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This phase I clinical trial is studying the side effects and best dose of RO4929097 when given together with capecitabine in treating patients with refractory solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RO4929097 together with chemotherapy may kill more tumor cells.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG capecitabine
  • DRUG gamma-secretase/Notch signalling pathway inhibitor RO4929097

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-06
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01158274 record still lists

NCT01158274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 3 interventions - of which laboratory biomarker analysis is the first listed.

NCT01158274 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01158274 about?

NCT01158274 is a clinical study titled "RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors". This phase I clinical trial is studying the side effects and best dose of RO4929097 when given together with capecitabine in treating patients with refractory solid tumors. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy...

What is the current status of trial NCT01158274?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-06.

What interventions are being tested in trial NCT01158274?

The interventions under investigation include: laboratory biomarker analysis (OTHER), capecitabine (DRUG), gamma-secretase/Notch signalling pathway inhibitor RO4929097 (DRUG).

Who is sponsoring clinical trial NCT01158274?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01158274's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT01158274, the US trial registry maintained by the National Library of Medicine. NCT01158274 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.