Dose Escalation Study of MLN0128 in Participants With Advanced Malignancies

Phase 1 Completed 198 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2010-01-04
Primary completion: 2019-02-07
Completion: 2019-02-07

Publications

Voss MH, Gordon MS, Mita M, Rini B, Makker V, Macarulla T, Smith DC, Cervantes A, Puzanov I, Pili R, Wang D, Jalal S, Pant S, Patel MR, Neuwirth RL, Enke A, Shou Y, Sedarati F, Faller DV, Burris HA 3rd. Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or bladder cancer. Br J Cancer. 2020 Nov;123(11):1590-1598. doi: 10.1038/s41416-020-01041-x. Epub 2020 Sep 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sapanisertib	Small molecule	2 mg	Oral
Subject	Sapanisertib	Small molecule	4 mg	Oral
Subject	Sapanisertib	Small molecule	5 mg	Oral
Subject	Sapanisertib	Small molecule	6 mg	Oral
Subject	Sapanisertib	Small molecule	7 mg	Oral
Subject	Sapanisertib	Small molecule	9 mg	Oral
Subject	Sapanisertib	Small molecule	10 mg	Oral
Subject	Sapanisertib	Small molecule	12 mg	Oral
Subject	Sapanisertib	Small molecule	13 mg	Oral
Subject	Sapanisertib	Small molecule	15 mg	Oral
Subject	Sapanisertib	Small molecule	16 mg	Oral
Subject	Sapanisertib	Small molecule	20 mg	Oral
Subject	Sapanisertib	Small molecule	30 mg	Oral
Subject	Sapanisertib	Small molecule	40 mg	Oral

Indications

No indication recorded.