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Phase II Study of TAK228 in Relapsed Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Phase II Study of TAK228 in Relapsed Lymphoma

NCT02727777•M.D. Anderson Cancer Center

Summary

The goal of this clinical research study is to learn if TAK-228 can help to control relapsed lymphoma. The safety of this drug will also be studied.

Detailed Description

Study Drug Administration: If you are found to be eligible for this study, you will begin taking capsules of TAK-228 in 28-day cycles. You will take the drug 1 time every day at about the same time. You should take the drug with about a cup (8 ounces) of water after eating a light meal. You should fast for 2 hours before and 1 hour after each dose. If you vomit or have other digestive side effects that prevent you from taking a dose, that dose should be skipped. If you vomit up a dose, that dose should not be retaken. In both cases, wait until the next day to take another dose. In no case should you double or repeat a dose. You should record any vomiting in the dose diary the study staff provides you with. Study Visits: Within 3 days before you start taking TAK-228, blood (about 2 teaspoons) will be drawn for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug. On Day 1 of each cycle: * You will have a physical exam. * Blood (about 2-3 tablespoons) will be drawn for routine tests. You must fast for 4 hours before this blood draw. Some of these draws will be used for a diabetes test. If you can become pregnant, part of this sample will be used for a pregnancy test. * Blood (about 2 teaspoons) will be drawn for biomarker testing (Cycles 1 and 2 only). * You will have an EKG (within 3 days of each cycle after Cycle 1). On Days 8 and 22 of Cycle 1, you will have a physical exam. On Day 15 of Cycle 1: * You will have a physical exam * Blood (about 2-3 tablespoons) will be drawn for routine tests. Within 5 days before Day 1 of Cycle 3, then every even-numbered cycle after that (Cycles 4, 6, 8, and so on), you will have CT scans, chest x-rays, and a bone marrow biopsy/aspiration to check the status of the disease. If the study doctor thinks it is in your best interest, you will have PET/CT scans every 2 cycles to check the status of the disease. Blood Sugar Testing: You will be given a glucometer to check your pre-dose blood sugar levels at home every day. The study staff will teach you how to use the glucometer and what an abnormal reading looks like. You must tell the study staff right away if you have any abnormal readings. The frequency of in-home fasting glucose testing may be reduced to once weekly if the doctor thinks it is needed. Length of Study: You may continue to receive the study drug for up to 12 cycles. You will no longer be able to take the drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation in this study will be over after the follow-up phone calls have finished. End-of-Treatment Visits: About 1 week after you stop taking the study drug: * You will have a physical exam * Blood (about 2-3 tablespoons) will be drawn for routine tests and to test for diabetes. This will include a pregnancy test if you are able to become pregnant. * You will have an EKG. About 2 weeks after you stop taking the study drug, you will have CT scans and chest x-rays to check the status of the disease. If the study doctor thinks it is needed, you will also have a bone marrow biopsy/aspiration to check the status of the disease. Within 2 weeks after you stop taking the study drug, blood (about 2 teaspoons) will be drawn for biomarker testing. This is an investigational study. TAK-228 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can describe how the study drug is designed to work. Up to 75 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
•3. Female patients who: are postmenopausal for at least 1 year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice 1 effective methods of contraception and one additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer, as mandated bu local labeling \[eg,USPI, SmPC, etc;\]) after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence \[e.g, calendar, ovulation, symptothermal, postovulation methods\] and withdrawal,spermicides only, ad lactational amenorrhea are not acceptable methods of contraception.Female and male condoms should not be used together.
•4. Male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence \[e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together; Agree not to donate sperm during the course of this study or 120 days after receiving their last dose of study drug
•5. Patients must have a diagnosis of prior treated diffuse large b-cell lymphoma, mantle cell lymphoma, transformed lymphoma, follicular lymphoma (any grade), small lymphocytic lymphoma, marginal zone lymphoma, or Hodgkin lymphoma with at least 2 lines of therapy without a curative treatment options.
•6. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status \</= 2.
•7. Adequate organ function, as specified below, within 3 weeks before the first dose of study drug: a) Bone marrow reserve consistent with: absolute neutrophil count (ANC) \>/=1.5 x 10\^9/L; platelet count \>/=100 x 10\^9/L; hemoglobin \>/=9 g/dL without transfusion within 1 week preceding study drug administration; b) Hepatic: total bilirubin \< /=1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase-AST and alanine aminotransferase ALT) \</= 2.5 x ULN (\</= 5 x ULN if liver metastases are present); c) Renal: creatinine clearance \>/= 50 mL/min based either on Cockcroft-Gault estimate or based on urine collection (12 or 24 hour); d) Metabolic: fasting serum glucose (\</=130 mg/dL) and fasting triglycerides \</=300 mg/dL;
•8. Ability to swallow oral medications;
•9. Measurable disease, defined as \>/=1.5 cm on imaging assessment.

Exclusion Criteria

•1. Eligible for therapy for the lymphoid malignancy which has a high likelihood of a curative result in the opinion of the investigator.
•2. Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period
•3. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
•4. Concurrent malignancies except basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ treated with curative intent. Any cancer from which the patient has been disease free for at least 2 years is permissible.
•5. Treatment with any investigational products within 14 days before the first dose of study drug
•6. Failed to recover to baseline or stable grade 1 from the reversible effects of prior anticancer therapies with the exception of alopecia.
•7. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of TAK228; such as significant chronic diarrhea. In addition, patients with enteric stomata are also excluded.
•9. History of any of the following within the last 6 months prior to study entry: ischemic myocardial event, including angina requiring therapy and artery revascularization procedures; Ischemic cerebrovascular event, including TIA and artery revascularization procedures; Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia); Placement of a pacemaker for control of rhythm; New York Heart Association (NYHA) Class III or IV heart failure; Pulmonary embolism.
•10. History of any of the following within the last 6 months prior to study entry: Requirement of inotropic support; Serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia); Placement of a pacemaker for control of rhythm
•11. Significant active cardiovascular or pulmonary disease at the time of study entry, including: uncontrolled high blood pressure (i.e., systolic blood pressure \>180 mm Hg, diastolic blood pressure \> 95 mm Hg) Use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed; Pulmonary hypertension; Uncontrolled asthma or O2 saturation \< 90% by ABG (Arterial Blood Gas) analysis or pulse oximetry on room air; Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement; medically significant (symptomatic) bradycardia; History of arrhythmia requiring an implantable cardiac defibrillator; Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval \> 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes).
+8 more criteria

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

March 1, 2017

Primary Completion Date

July 10, 2018

Completion Date

July 10, 2018

Last Updated

March 12, 2020

Enrollment

ACTUAL participants

Conditions

Lymphoma

Interventions

TAK228

DRUG

Blood Sugar Testing

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study of TAK228 in Relapsed Lymphoma

Inclusion Criteria

Exclusion Criteria

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