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Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

NCT02812056 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-03-27

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of alisertib and TAK-228 that can be given to participants with advanced solid tumors that are associated with HPV. Researchers also want to learn if the study drug combination can help to control advanced solid tumors.

Conditions

  • Malignant Neoplasms of Digestive Organs
  • Malignant Neoplasms of Female Genital Organs
  • Malignant Neoplasms of Lip Oral Cavity and Pharynx
  • Malignant Neoplasms of Male Genital Organs

Interventions

DRUG

Alisertib

Dose Escalation Phase: Starting dose of Alisertib: 30 mg by mouth 2 times a day on Days 1 - 7 each 21 day cycle. Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase.

DRUG

TAK-228

Dose Escalation Phase: Starting dose of TAK-228: 1 mg by mouth daily Days 3 - 18, with the exception of 2 mg daily Days 3 - 7 and 10 - 14 schedule in a 21 day cycle. Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Siqing Fu, MD, PHD · 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
2016-09-30
Primary Completion
2021-09-30

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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 NCT02812056 on ClinicalTrials.gov