Advanced Solid Malignancies Clinical Trial
Official title:
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
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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