Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Fallopian Tube Neoplasms

Carcinosarcoma

Mixed Tumor, Mullerian

Adenocarcinoma, Clear Cell

Cystadenocarcinoma

Carcinoma, Endometrioid

Adenoma, Pleomorphic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Neoplasms, Cystic, Mucinous, and Serous

Endometrial Neoplasms

Uterine Neoplasms

Sarcoma

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Adenocarcinoma of the Appendix

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Tin Fluorides

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria

Paclitaxel, concentrate for solution for infusion 80mg per metre squared on day 1, 8 and 15 of a 28 day cycle. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria

TAK228, oral capsule 4mg on days 2-4, 9-11, 16-18 and 23-25 of a 28 day cycle i.e. in concurrence with paclitaxel. Cycles continue until disease progression and/or death, unacceptable adverse event/s, patient and/or investigator decision, other protocol stopping criteria

TAK228

Jonathan Krell

DICE is a randomised study recruiting 126 women over 3 years from hospitals in the UK and Germany. Eligible patients will have tissue based diagnosis of advanced/recurrent ovarian cancer (clear cell, endometrioid or high grade serous or carcinosarcoma), have had chemotherapy before, and be platinum-resistant (the cancer has returned/grown significantly during or within 6 months of platinum-containing chemotherapy).

This study is for women with ovarian cancer that has come back following treatment, and is resistant to platinum chemotherapy. Weekly paclitaxel chemotherapy is standard for these women, but there is a need to provide more effective treatments. TAK228 is an unlicensed oral drug that blocks the PI3K/AKT/mTOR pathway, which is important to the survival and spread of cancer cells. When TAK228 is combined with paclitaxel in the laboratory, the anti-cancer effect of both is increased. The DICE trial will show whether using TAK228 in combination with weekly paclitaxel is more effective at treating the patient population than weekly paclitaxel alone. DICE will also look for 'biomarkers' that measure the activity of the cancer and the effects of treatment. This may help us understand which women might benefit from receiving TAK228 and weekly paclitaxel in future.

Randomisation will be to one of 2 groups (63 women in each). Treatment is divided into 4 week 'cycles':

Group 1: weekly paclitaxel for 3 weeks followed by 1 week rest each cycle

Group 2: weekly paclitaxel (see Group 1) plus TAK228 for 12 days each cycle

Women will stop treatment when the cancer grows significantly, there are unacceptable side effects, or the investigator and/or patient decides to stop. Women will be followed up until 6 months after the last patient receiving study treatment stops that treatment.

Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

An International Multi-centre Randomised Phase II Study to Assess the Efficacy of TAK228 in Combination With Intravenous Weekly Paclitaxel Compared With Weekly Paclitaxel Alone in Women With Advanced/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

PFS (as assessed by RECIST v1.1), defined as time from study entry to first evidence of disease progression or death due to any cause

PFS (as assessed by RECIST v1.1) at 24 weeks, defined as time from study entry to first evidence of disease progression or death due to any cause

ORR (as assessed by RECIST v1.1) defined by complete response (CR) or partial response (PR)

DOR defined as time from study entry to change in response from CR or PR to stable disease (SD) or progressive disease (PD) (as assessed by RECIST v1.1)

TTP defined as time from study entry to first evidence of disease progression or death due to any cause

A response according to CA125 has occurred if there is at least a 50% reduction in CA125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days. Patients can be evaluated according to CA125 only if they have a pretreatment sample that is at least twice the upper limit of normal and within 2 weeks prior to starting treatment

OS defined as time from study entry to death due to any cause or to study termination

The number of patients experiencing 1 or more AEs will be summarised by the event name, relationship to study treatment and severity

EORTC QLQ-C30 is used to assess the overall quality of life in cancer patients. It consists of 30 questions and 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement

EORTC QLQ-OV28 is used to assess the overall health-related quality of life in patients with local or advanced ovarian cancer. EORTC QLQ-OV28 consists of 28 questions evaluated across eight multi-item and 4 single item scales: abdominal/GI symptoms, peripheral neuropathy, hormonal symptoms, body image, attitude to disease/treatment, chemotherapy side effects, and sexuality, and single items scales for indigestion/heartburn, hair loss, upset due to hair loss, and taste. Questions use a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment

Takeda Pharmaceuticals International, Inc.

North Eastern German Society of Gynaecological Oncology

Imperial College London

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Phase II - Aggressive NHL: Diffuse Large B Cell Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), Transformed Large Cell Lymphoma, and Follicular Lymphoma (FL) grade 3b Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Phase II - Indolent NHL: Follicular Lymphoma (FL) grade 1-3a, Small Lymphocytic Lymphoma (SLL), Marginal Zone Lymphoma (MZL) Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Phase II - Hodgkin Lymphoma Group

Participants take TAK-228 1 time every day of a 28 day cycle.

Treatment continues until progression of disease occurs, or a maximum of 12 months of treatment.

Participant checks blood sugar every day before TAK-228 dose.

Starting dose of TAK228: 3 mg by mouth every day of a 28 day cycle.

Participant given a glucometer to check pre-dose blood sugar levels at home every day.

Blood Sugar Testing

Jason R. Westin, MD

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.

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.

Phase II Study of TAK228 in Relapsed Lymphoma

Assessed with reverse phase protein arrays after exposure to TAK228,

RA was defined by Lugano Criteria \& based on CT scans obtained at screening \& after completion of every 2 cycles of therapy. Complete Radiographic Response Target Nodes must regress to \<=1.5cm in longest dimension,No extralymphatic sites of disease. PR \>=50% decrease in sum of the product of diameters of up to 6 target measurable nodes and extranodal sites. When a lesion is too small to measure on CT, 5 mmx5mm is assigned. When not visible on CT, assign 0x0 mm. For a node 5mmx5mm use actual measurement. SD\< 50% decrease in sum of the product of diameters of up to 6 target measurable nodes \& extranodal sites, no criteria for disease progression are met. Progressive disease requires one of the following:An individual node must be abnormal with: LDi 1.5cm \& Increase by 50% from PPD nadir \& an increase in LDi or SDi from nadir 0.5cm for lesions 2cm,1cm for lesions 2cm. In case of splenomegaly, the splenic length must increase by \>=50% of the extent of its prior increase beyond baseline.

Progression free survival, duration of response and overall survival analysis could not be properly evaluated due to patients being taken off study early due to progression of disease but safety and tolerability were reported through safety event reports, please see AEs-serious and non-serious section for this.

Takeda

M.D. Anderson Cancer Center

Adverse events were assessed on 2 patients that were eligible to participate. They were not assessed for 2 patients that were screen failures.

Aggressive NHL(DLBCL/MCL/transformed large cell lymphoma/FL grade 3b

Aggressive NHL(DLBCL/MCL/Transformed Large Cell Lymphoma/FL gr

Indolent NHL:FL grade1-3a,SLL,MZL

Hodgkin Lymphoma

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Westin (Principal Investigator) was only participating in the DLBCL arm.

Dr. Jason R. Westin/Lymphoma/Myeloma

No analysis could be performed due to 2 participants failed screening and 2 participants disease progressed before analysis could be performed

Response Assessment (RA)

Adverse events were evaluated for the time patients were on study however due to early progression of disease, patients did not finish the treatment and adverse events reported were not conclusive of toxicity related to drug. Updated to two participants for the secondary outcome.

Number of Participants With Adverse Events

Exploratory objective was not analyzed because patients came off study before it could be analyzed, no data were collected.

Exploratory Objective to Define Change of mTOR Pathway Protein Phosphorylation and the Incidence of Activating Mutations in MTOR and Related Genes.

Overall Study

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hodgkin Disease

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Peripheral T-cell Lymphoma

Anaplastic Large Cell Lymphoma

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Participants receive Brentuximab Vedotin by vein on Day 1 of each cycle.

Participants take TAK228 by mouth either every day, or on a 5 days on/2 days off schedule. The study doctor will tell participant how often to take the study drug.

Each cycle is 21 days.

Participant monitors glucose (sugar) levels at home with a glucose monitor during the first 2 months participant is taking the study drug.

1.8 mg/kg by vein on Day 1 per cycle by vein over about 30 minutes on Day 1 of each cycle.

Starting Dose and Schedule of TAK228: 2 mg by mouth, 5 days on and 2 days off per week with repeated weekly cycles. The study doctor will tell participant how often to take the study drug.

Participant monitors glucose (sugar) levels at home with a glucose monitor during the first 2 months participant is taking the study drug.

Glucose Monitor

Michelle A. Fanale, MD

The goal of this clinical research study is to find the highest tolerable dose of TAK228 that can be given in combination with brentuximab vedotin in patients with lymphoma. The safety of this combination will also be studied.

This is an investigational study. TAK228 is not FDA approved or commercially available. It is currently being used for research purposes only. Brentuximab vedotin is FDA approved and commercially available for the treatment of different types of lymphoma. The study doctor can explain how the study drugs are designed to work.

Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of TAK228 based on when you join this study. Up to 4 dose levels of TAK228 will be tested. About 3-6 participants will be enrolled at each dose level. 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 TAK228 is found.

Your dose of brentuximab vedotin will stay the same. However, if the doctor thinks it is needed for your safety, it may be lowered.

Study Drug Administration:

Each cycle is 21 days.

You will receive brentuximab vedotin by vein over about 30 minutes on Day 1 of each cycle.

You will take TAK228 by mouth either every day or on a 5 days on/2 days off schedule (a "5/2 schedule," where you take the study drug every day for 5 days in a row and then do not take any TAK228 for 2 days in a row). The study doctor will tell you how often to take the study drug.

Each dose of TAK228 should be taken at about the same time each day on an empty stomach with 8 ounces (about 1 cup) of water. You should fast for 2 hours before and 1 hour after each dose.

Length of Study:

You may receive up to 16 cycles of study drugs. You will no longer be able to take the study drugs 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 about 2 years of follow-up (described below).

Study Visits:

One (1) time every week while receiving the study drugs, blood (about 1-2 tablespoons) will be drawn for routine tests.

Within 3 days before the start of Cycles 2 and beyond:

* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood sugar levels. If you can become pregnant, part of this blood sample will be used for a pregnancy test. You should fast for about 8-10 hours before this draw.
* Urine will be collected for routine tests.
* You will have an EKG.

At the end of Cycle 1:

°Blood (about 1-2 tablespoons) will be drawn for biomarker testing.

At the end of Cycle 3 and every 3 cycles after that (Cycles 6, 9, 12, and so on), you will have a CT or PET/CT scan.

At-Home Glucose Monitoring:

You are required to monitor your glucose (sugar) levels at home during the first 2 months you are taking the study drug. If the doctor thinks it is needed, you may be asked to continue monitoring your glucose (sugar) levels at home. The study staff will give you a glucose monitor (called a glucometer) and teach you how and when to use it. You will bring the glucometer with you to each study visit so the study staff can collect the results of the testing.

The study team will tell you what an "abnormal" level is and when to contact the study doctor/study staff.

You will need to return the glucometer to the study staff at the end of the study.

End-of-Dosing Visit:

Within 21 days after your last dose of study drugs:

* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood sugar levels. If you can become pregnant, part of this sample will be used for a pregnancy test. You should fast for about 8-10 hours before this draw.
* Urine will be collected for routine tests.
* You will have an EKG.
* You will have a PET/CT or CT scan.

Follow-Up:

Every 4 months for up to 2 years:

* You will have a physical exam.
* Blood (about 1-2 tablespoons) will be drawn for routine tests and to check your blood sugar levels. You should fast for about 8-10 hours before this blood draw.
* You will have a CT scan.

If you are found to be eligible to receive a transplant as part of your standard care, you may receive a transplant. You will sign a separate consent explaining that procedure and its risks in more detail. If you have a stem cell transplant, you will stop having follow-up visits as part of this study.

Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas

An Open Label Phase I Study of Brentuximab Vedotin Plus TAK228 for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas

DLT defined as a drug-related adverse event during the first cycle of treatment

MTD is the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate.

Response determined according to the Lugano Classification.(Cheson, et al 2014)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)	NCT03648489	Ovarian Cancer Ovarian Neoplas... Ovarian Carcino... Ovarian Serous ... Ovarian Endomet... Ovarian Clear C... Fallopian Tube ... Fallopian Tube ... Primary Periton... Primary Periton...	Paclitaxel TAK228	18 Years -	Imperial College London
Phase II Study of TAK228 in Relapsed Lymphoma	NCT02727777	Lymphoma	TAK228 Blood Sugar Tes...	18 Years -	M.D. Anderson Cancer Center
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)	NCT03648489	Ovarian Cancer Ovarian Neoplas... Ovarian Carcino... Ovarian Serous ... Ovarian Endomet... Ovarian Clear C... Fallopian Tube ... Fallopian Tube ... Primary Periton... Primary Periton...	Paclitaxel TAK228	18 Years -	Imperial College London
Study of Brentuximab Vedotin Plus TAK228 for Relapsed/Refractory Classical Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma and Other CD30+Peripheral T-Cell Lymphomas	NCT03205891	Malignant Neopl... Classical Hodgk... Anaplastic Larg... CD30+ Periphera...	Brentuximab Ved... TAK228 Glucose Monitor	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for tak228

Every month we try and update this database with for tak228 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tak228

Every month we try and update this database with for tak228 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tak228 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.