NCT01058707

Dose Escalation Study of MLN0128 in Participants With Advanced Malignancies

A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent INK128 in Subjects With Advanced Malignancies Followed by an Expansion in Subjects With Measurable Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called MLN0128. MLN0128 is being tested to treat people who have Advanced Malignancies. The study enrolled approximately 198 patients. Participants were assigned to one of the following dose regimens in the Dose Escalation Phase to establish the Maximum Tolerated Dose (MTD): * MLN0128 QD * MLN0128 QW * MLN0128 QDx3dQW * MLN0128 QDx5dQW MLN0128 capsule, orally, once daily (QD) or Once weekly (QW) in the Dose Escalation Phase until MTD was established. Once MTD was determined, participants were then enrolled in the Dose Expansion Phase to receive: * MLN0128 5 mg QD * MLN0128 30 mg QW * MLN0128 40 mg QW This multi-centre trial was conducted worldwide. The overall time to participate in this study was approximately 244 weeks. Participants will make multiple visits to the clinic, and were contacted by telephone OR plus a final visit after last dose of study drug for a follow-up assessment.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	MLN0128	MLN0128 capsules

Timeline

• Start date: 2010-01-04
• Primary completion: 2019-02-07
• Completion: 2019-02-07
• First posted: 2010-01-29
• Last updated: 2020-04-01
• Results posted: 2020-04-01

Locations

16 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study