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NCT01058707 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Study of MLN0128 in Participants With Advanced Malignancies

A Phase 1 study of Advanced Solid Malignancies, sponsored by Millennium Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
198
Enrollment target
16
Study locations

NCT01058707: Completed Phase 1 study of Advanced Solid Malignancies, sponsored by Millennium Pharmaceuticals.

NCT01058707 is a Phase 1 study of Advanced Solid Malignancies that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 198 participants, roughly in line with the 212-participant average among 6 other Advanced Solid Malignancies trials with a reported enrollment target. The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01058707, a Phase 1 study of Advanced Solid Malignancies, has completed, sponsored by Millennium Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
198 participants
Enrollment target
16
Study locations

Study Summary

This is a Phase I, open label, Dose Escalation study of oral administration of single agent MLN0128 in participants with Advanced Malignancies followed by an Expansion Phase in participants with renal cell carcinoma, endometrial cancer or urothelial cancer who have measurable disease.

Primary Outcome

MTD was defined as the highest dose level of MLN0128 at which no more than 1 out of 6 evaluable participants experienced a DLT during the first cycle (28 days) of therapy.

Conditions Studied

Advanced Solid Malignancies

Interventions

  • DRUG MLN0128

Study Locations (16)

Florida

  • - Miami
  • - Sarasota

Michigan

  • - Ann Arbor
  • - Detroit

New York

  • - Buffalo
  • - New York

Other

  • - Barcelona
  • - Valencia

Arizona

  • - Scottsdale

California

  • - Los Angeles

Indiana

  • - Indianapolis

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2010-01-04
Est. Completion 2019-02-07
Phase Phase 1
Millennium Pharmaceuticals

135 total trials

What the finished NCT01058707 record still lists

NCT01058707 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 212-participant average among 6 other Advanced Solid Malignancies trials with a reported enrollment target.

The record links to 1 condition, with Advanced Solid Malignancies appearing as the primary indexed condition, and to 1 intervention - of which MLN0128 is the first listed.

NCT01058707 lists 16 locations in 12 states (Florida, Michigan, New York).

Frequently Asked Questions

What is clinical trial NCT01058707 about?

NCT01058707 is a clinical study titled "Dose Escalation Study of MLN0128 in Participants With Advanced Malignancies". This is a Phase I, open label, Dose Escalation study of oral administration of single agent MLN0128 in participants with Advanced Malignancies followed by an Expansion Phase in participants with renal cell carcinoma, endometrial cancer or urothelial cancer who have measurable disease.

What is the current status of trial NCT01058707?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2010-01-04. Estimated completion is 2019-02-07.

What conditions does trial NCT01058707 study?

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

What interventions are being tested in trial NCT01058707?

The interventions under investigation include: MLN0128 (DRUG).

Who is sponsoring clinical trial NCT01058707?

This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01058707 being conducted?

This trial has 16 study locations across Arizona, California, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01058707, the US trial registry maintained by the National Library of Medicine. NCT01058707 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.