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NCT01497925 · ClinicalTrials.gov registry record · Phase 1

Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer

A Phase 1 study of Prostate Cancer and Solid Tumors, sponsored by Polaris Group.

Completed
Registry status
Phase 1
Development phase
43
Enrollment target
1
Study location

NCT01497925 is a Phase 1 study of Prostate Cancer and Solid Tumors that has completed, run by Polaris Group. The registered enrollment target is 43 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01497925, a Phase 1 study of Prostate Cancer and Solid Tumors, has completed, sponsored by Polaris Group.

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

Study Summary

This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageable side effects) in cancer patients due to the unique mechanism of action of ADI-PEG 20. The investigators also hypothesize that the combination of ADI-PEG 20 and docetaxel will result in enhanced tumor cell apoptosis in part due to autophagy and that this will be particularly relevant in CRPC.

Interventions

  • DRUG ADI-PEG 20

Study Locations (1)

California

  • University of California at Davis - Sacramento

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2011-09-06
Est. Completion 2018-08-31
Phase Phase 1

Sponsor

Polaris Group

13 total trials

What the Registry Record Tells You About NCT01497925

The ClinicalTrials.gov registry entry for NCT01497925 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The listed sponsor is Polaris Group, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which ADI-PEG 20 is the first listed.

NCT01497925 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01497925 about?

NCT01497925 is a clinical study titled "Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer". This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC). The investigators hypothesize that the combination will result in greater tumor cytotoxicity with an acceptable toxicity profile (i.e., manageabl...

What is the current status of trial NCT01497925?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2011-09-06. Estimated completion is 2018-08-31.

What conditions does trial NCT01497925 study?

This clinical trial studies the following conditions: Prostate Cancer, Solid Tumors.

What interventions are being tested in trial NCT01497925?

The interventions under investigation include: ADI-PEG 20 (DRUG).

Who is sponsoring clinical trial NCT01497925?

This trial is sponsored by Polaris Group, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01497925 being conducted?

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

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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.