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NCT01196416 · ClinicalTrials.gov registry record · Phase 1

Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma

A Phase 1 study of Recurrent Melanoma and Stage IV Skin Melanoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
14
Enrollment target
1
Study location

NCT01196416 is a Phase 1 study of Recurrent Melanoma and Stage IV Skin Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01196416, a Phase 1 study of Recurrent Melanoma and Stage IV Skin Melanoma, has completed, sponsored by National Cancer Institute (NCI).

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

Study Summary

This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and temozolomide and to see how well they work in treating patients with recurrent or metastatic melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, vinblastine, and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with combination chemotherapy may kill more tumor cells.

Conditions Studied

Recurrent Melanoma Stage IV Skin Melanoma

Interventions

  • DRUG Cisplatin
  • OTHER Laboratory Biomarker Analysis
  • DRUG Temozolomide
  • OTHER Pharmacological Study
  • DRUG Gamma-Secretase Inhibitor RO4929097

Study Locations (1)

New York

  • Memorial Sloan-Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2010-08
Est. Completion 2015-08
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT01196416

The ClinicalTrials.gov registry entry for NCT01196416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 172-participant average among 23 other Recurrent Melanoma trials with a reported enrollment target (92% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Recurrent Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.

NCT01196416 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01196416 about?

NCT01196416 is a clinical study titled "Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma". This phase Ib/II trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 when given together with cisplatin, vinblastine, and temozolomide and to see how well they work in treating patients with recurrent or metastatic melanoma. Gamma-secretase/No...

What is the current status of trial NCT01196416?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2010-08. Estimated completion is 2015-08.

What conditions does trial NCT01196416 study?

This clinical trial studies the following conditions: Recurrent Melanoma, Stage IV Skin Melanoma.

What interventions are being tested in trial NCT01196416?

The interventions under investigation include: Cisplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Pharmacological Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).

Who is sponsoring clinical trial NCT01196416?

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

Where is trial NCT01196416 being conducted?

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

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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.