CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 83 enrolled
Drug / intervention
Sapanisertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02159989
NCT02159989Phase 1Completed
CompareCT.gov

Phase I Study of MLN0128 (TAK-228) (NSC# 768435) in Combination With Ziv-Aflibercept (NSC# 724770) in Patients With Advanced Cancers

National Cancer Institute (NCI)·interventional·Posted Jun 10, 2014·Updated Oct 20, 2025

In Brief

A Phase 1 clinical trial evaluating Sapanisertib and Ziv-Aflibercept for Advanced Malignant Solid Neoplasm and 7 related conditions. Completed, enrolled 83 participants across 1 site.

Detailed Summary

This phase I trial studies the side effects and best dose of sapanisertib and ziv-aflibercept in treating patients with solid tumors that have come back (recurrent) and have spread to another place in the body (metastatic) or cannot be removed by surgery (unresectable). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ziv-aflibercept may stop the growth of solid tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving sapanisertib with ziv-aflibercept may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Malignant Solid Neoplasm, Fibrolamellar Carcinoma, Metastatic Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Neuroendocrine Tumor, Recurrent Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm, Unresectable Solid Neoplasm
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2014
Enrollment StartJun 18, 2014
Primary CompletionJun 29, 2021
Study CompletionJan 29, 2024
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 12.1 years ago

Interventions

Sapanisertibdrug

Given PO

Ziv-Afliberceptbiological

Given IV