Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies

Phase 1 Completed 68 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase I, open label, dose escalation study of oral administration of MLN0128 in combination with paclitaxel, with/without trastuzumab, in participants with advanced solid malignancies.

Timeline

Start: 2011-02-28
Primary completion: 2017-09-15
Completion: 2017-09-15

Publications

Burris HA 3rd, Kurkjian CD, Hart L, Pant S, Murphy PB, Jones SF, Neuwirth R, Patel CG, Zohren F, Infante JR. TAK-228 (formerly MLN0128), an investigational dual TORC1/2 inhibitor plus paclitaxel, with/without trastuzumab, in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2017 Aug;80(2):261-273. doi: 10.1007/s00280-017-3343-4. Epub 2017 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Sapanisertib	Small molecule	6 mg	Oral
Subject	Sapanisertib	Small molecule	7 mg	Oral
Subject	Sapanisertib	Small molecule	8 mg	Oral
Subject	Sapanisertib	Small molecule	9 mg	Oral
Subject	Sapanisertib	Small molecule	10 mg	Oral
Subject	Sapanisertib	Small molecule	30 mg	Oral
Subject	Sapanisertib	Small molecule	40 mg	Oral
Subject	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous

Dose Escalation Study of MLN0128 in Combination With Paclitaxel, With/Without Trastuzumab, in Subjects With Advanced Solid Malignancies

Summary

Timeline

Publications

Drugs

Indications