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NCT01957995 · ClinicalTrials.gov registry record · Phase 1

Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors

A Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of Southern California.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT01957995: Completed Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University of Southern California.

NCT01957995 is a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by University of Southern California. The registered enrollment target is 13 participants, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01957995, a Phase 1 study of Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by University of Southern California.

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

Study Summary

This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Primary Outcome

Descriptive statistics of all pharmacokinetic parameters would be computed and reported for free and total docetaxel. Maximum blood concentration (Cmax), area under the curve (AUC)0-t, AUC0-infinity, time to Cmax (Tmax), terminal elimination rate constant (lambda z), half-life (t1/2), AUC percent extrapolated (%Extrap), clearance (CL), and volume of distribution (Vd) will be calculated.

Interventions

  • OTHER pharmacological study
  • DRUG nanosomal docetaxel lipid suspension

Study Locations (1)

California

  • USC Norris Comprehensive Cancer Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2013-11-08
Est. Completion 2016-07-14
Phase Phase 1
University of Southern California

617 total trials

What the finished NCT01957995 record still lists

NCT01957995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 501-participant average among 83 other Unspecified Adult Solid Tumor, Protocol Specific trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Unspecified Adult Solid Tumor, Protocol Specific appearing as the primary indexed condition, and to 2 interventions - of which pharmacological study is the first listed.

NCT01957995 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT01957995 about?

NCT01957995 is a clinical study titled "Nanosomal Docetaxel Lipid Suspension in Treating Patients With Advanced Solid Tumors". This randomized phase I trial studies the side effects and best dose of nanosomal docetaxel lipid suspension in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as nanosomal docetaxel lipid suspension, work in different ways to stop the growth of tumor cells, either by ...

What is the current status of trial NCT01957995?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2013-11-08. Estimated completion is 2016-07-14.

What conditions does trial NCT01957995 study?

This clinical trial studies the following conditions: Unspecified Adult Solid Tumor, Protocol Specific.

What interventions are being tested in trial NCT01957995?

The interventions under investigation include: pharmacological study (OTHER), nanosomal docetaxel lipid suspension (DRUG).

Who is sponsoring clinical trial NCT01957995?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01957995 being conducted?

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

Similar trials for Unspecified Adult Solid Tumor, Protocol Specific

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.

Where NCT01957995's enrollment target sits among peer trials

13 80th of 83 higher than 4 of 83 other Unspecified Adult Solid Tumor, Protocol Specific trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Unspecified Adult Solid Tumor, Protocol Specific 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 NCT01957995, the US trial registry maintained by the National Library of Medicine. NCT01957995 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.