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NCT02644278 · ClinicalTrials.gov registry record · Phase 1

First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy

A Phase 1 study of Advanced Solid Tumor, sponsored by EMD Serono Research & Development Institute.

Completed
Registry status
Phase 1
Development phase
15
Enrollment target
5
Study locations

NCT02644278 is a Phase 1 study of Advanced Solid Tumor that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 15 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT02644278, a Phase 1 study of Advanced Solid Tumor, has completed, sponsored by EMD Serono Research & Development Institute.

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target
5
Study locations

Study Summary

The purpose of this study was to evaluate the safety and tolerability of VX-984 (M9831) administered alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination with PLD in participants with advanced solid tumors.

Conditions Studied

Advanced Solid Tumor

Interventions

  • DRUG VX-984 120 mg + PLD 40 mg/m^2
  • DRUG VX-984 240 mg + PLD 40 mg/m^2
  • DRUG VX-984 480 mg + PLD 40 mg/m^2
  • DRUG VX-984 720 mg + PLD 40 mg/m^2

Study Locations (5)

Texas

  • - Dallas
  • - Houston

Arizona

  • - Scottsdale

Massachusetts

  • - Boston

Tennessee

  • - Nashville

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2016-02-29
Est. Completion 2017-10-19
Phase Phase 1

Sponsor

EMD Serono Research & Development Institute

81 total trials

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What the Registry Record Tells You About NCT02644278

The ClinicalTrials.gov registry entry for NCT02644278 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (92% lower). The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which VX-984 120 mg + PLD 40 mg/m^2 is the first listed.

NCT02644278 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Texas, Arizona, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT02644278 about?

NCT02644278 is a clinical study titled "First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy". The purpose of this study was to evaluate the safety and tolerability of VX-984 (M9831) administered alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination with PLD in partic...

What is the current status of trial NCT02644278?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-02-29. Estimated completion is 2017-10-19.

What conditions does trial NCT02644278 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT02644278?

The interventions under investigation include: VX-984 120 mg + PLD 40 mg/m^2 (DRUG), VX-984 240 mg + PLD 40 mg/m^2 (DRUG), VX-984 480 mg + PLD 40 mg/m^2 (DRUG), VX-984 720 mg + PLD 40 mg/m^2 (DRUG).

Who is sponsoring clinical trial NCT02644278?

This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02644278 being conducted?

This trial has 5 study locations across Arizona, Massachusetts, Tennessee, Texas. 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.