Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01168011 · ClinicalTrials.gov registry record · Phase 1

Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors

A Phase 1 study of Solid Tumor, sponsored by Traws Pharma.

Completed
Registry status
Phase 1
Development phase
68
Enrollment target
1
Study location

NCT01168011 is a Phase 1 study of Solid Tumor that has completed, run by Traws Pharma. The registered enrollment target is 68 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01168011, a Phase 1 study of Solid Tumor, has completed, sponsored by Traws Pharma.

COMPLETED
Registry status
Phase 1
Development phase
68 participants
Enrollment target
1
Study location

Study Summary

This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of the study is to determine the highest dose of drug that can be given safely. The study will start by testing a low dose. If this dose is safe, then, higher and higher doses will be tested as long as the previous lower dose was safe. Safety will be determined by looking for any side effects or unusual laboratory values. It is important to know the highest safe dose so that additional studies can be done. The drug will be given in the form of capsules twice or three times a day for 21 consecutive days of 21-day cycles.

Conditions Studied

Interventions

  • DRUG rigosertib

Study Locations (1)

Colorado

  • University of Colorado at Denver Health and Sciences - Denver

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2010-07
Est. Completion 2015-12
Phase Phase 1

Sponsor

Traws Pharma

25 total trials

What the Registry Record Tells You About NCT01168011

The ClinicalTrials.gov registry entry for NCT01168011 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (69% lower). The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which rigosertib is the first listed.

NCT01168011 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT01168011 about?

NCT01168011 is a clinical study titled "Safety, Pharmacokinetics and Clinical Activity of Oral Rigosertib in Solid Tumors". This is a phase 1 study in which 2 to 72 patients with advanced cancer will receive oral doses of rigosertib, a new investigational (unapproved) anti-cancer drug. The objective of the study is to determine the highest dose of drug that can be given safely. The study will start by testing a low dose....

What is the current status of trial NCT01168011?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 68 participants. The study started on 2010-07. Estimated completion is 2015-12.

What conditions does trial NCT01168011 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT01168011?

The interventions under investigation include: rigosertib (DRUG).

Who is sponsoring clinical trial NCT01168011?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01168011 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.