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

Malignant Neoplasms of Female Genital Organs Clinical Trial

Official title: A Phase I Study of Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

Study Groups:

If participant is found to be eligible to take part in this study, they will be assigned to a dose level based on when they join the study. Up to 5 dose levels of alisertib and TAK-228 will be tested. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of alisertib and TAK-228 is found.

Up to 14 participants will be enrolled onto a Dose Expansion group after the highest tolerable dose combination has been found.

Study Drug Administration:

Each cycle is 21 days.

On Days 1-7 of each cycle, participant will take alisertib by mouth 2 times a day with a glass of water (about 4 ounces).

On Days 3-18 of each cycle, participant will take TAK-228 by mouth 1 time a day Participant should not eat or drink anything for 2 hours before and 1 hour after taking TAK-228.

Study Visits:

Participant will need to take their blood sugar levels every morning while they are on study. Participant will be given a blood sugar monitor and the study staff will show them how to use it. Participant will also have their blood sugar tested in the clinic Participant must fast for at least 8 hours before each of these blood sugar tests. If the doctor thinks it is in participant's best interest, this testing may be decreased to 1 time a week after the first 2 months.

During Week 1 of Cycle 1:

• Participant will have a physical exam.

• Blood (about 3 teaspoons) will be drawn for routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.

• Urine will be collected for routine tests

On Day 1 of Cycles 1 and 2, you will have an EKG.

One (1) time during Weeks 2 and 3 of Cycle 1, blood (about 2 teaspoons) for routine tests and to test participant's blood sugar.

One (1) time a week during Cycles 1 and 2, blood (about 2 teaspoons) will be drawn for routine tests.

During Week 1 of Cycle 2 and beyond:

• Participant will have a physical exam.

• Urine will be collected for routine tests.

During Week 1 of Cycle 3 and beyond, blood (about 4 teaspoons) will be drawn routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.

During Cycles 2, 4, and 6 and then every 3 cycles, participant will have a CT, MRI, or positron emission tomography (PET) scan to check the status of the disease.

Length of Study:

Participant may continue taking the study drugs for as long as they are benefitting. Participant will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, if the doctor thinks it is in their best interest, if the study is stopped, if they need treatment that is not allowed on this study, or if they are unable to follow study directions.

Patient's participation on the study will be over after the end-of-study visit.

End of Study Visit:

Within 30 days of participant's last dose of study drugs:

• Participant will have an EKG to check your heart function.

• Participant will have a physical exam.

• Urine will be collected for routine tests.

• Blood (about 3 teaspoons) will be drawn for routine tests and to test blood clotting, participant's blood fat levels, and their blood sugar levels.

• Participant will have a CT, MRI, or PET scan to check the status of the disease.

This is an investigational study. Alisertib and TAK-228 are not FDA approved or commercially available. They are currently being used for research purposes only.

The study doctor can explain how the study drugs are designed to work.

Up to 44 participants will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Genital Neoplasms, Male
• Lip Neoplasms
• 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
• Neoplasms
• Papilloma

• NCT number: NCT02812056
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 2016