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Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

NCT02159989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-10-17

Study results available
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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.

Conditions

  • Advanced 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

Interventions

DRUG

Sapanisertib

Given PO

BIOLOGICAL

Ziv-Aflibercept

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Aung Naing · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-18
Primary Completion
2021-06-29
Completion
2024-01-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02159989 on ClinicalTrials.gov