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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically

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
EMD Serono Research & Development Institute

81 total trials

What the finished NCT02644278 record still lists

NCT02644278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (92% lower).

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 lists 5 locations in 4 states (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.

Learn More About Clinical Trials

Similar trials for Advanced 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.

Where NCT02644278's enrollment target sits among peer trials

15 184th of 189 higher than 2 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor 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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Related registry views

Source: ClinicalTrials.gov NCT02644278, the US trial registry maintained by the National Library of Medicine. NCT02644278 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.