Phase II Study of TAK228 in Relapsed Lymphoma
Phase: PHASE1
Conditions: Lymphoma
Sponsor: M.D. Anderson Cancer Center

2014-0501
June 19, 2017
Abstract Page 1
Protocol Abstract Page
Phase II study of TAK-228 in Relapsed Lymphoma
2014-0501
Core Protocol Information
Study Chairman: 
Jason R. Westin
Department:
Lymphoma/Myeloma
Phone:
713-792-2860
Unit:
429
Full Title: 
Phase II study of TAK-228 in Relapsed Lymphoma
Protocol Phase:
Phase II
Version Status:
Activated -- Closed to new patient entry as of 11/27/2017
Version:
07
Document Status:
Final
Abstract
Objectives:
Primary Objectives
Phase II:
 The primary objective of the Phase II portion of the trial is to define the overall response rate, defined as the 
combination of complete (CR) and partial (PR) response rates, of TAK228 in patients with relapsed lymphoma.
Secondary Objectives
Phase II:
 The secondary objectives of the Phase II portion of the trial are to define the safety & tolerability, progression free 
survival, duration of response, and overall survival of TAK228 in patients with relapsed lymphoma.
Exploratory Objectives
The exploratory objectives are to define:
Determination of response associated clinical characteristics,

The incidence of activating mutations in MTOR and related genes in patients who respond to TAK228 

in their archival lymphoma biopsy tissue, 
The change in phosphorylation of mTORC1/2 target proteins and related  signaling proteins at 

baseline and after therapy with TAK228 in peripheral blood mononuclear cells by utilizing reverse 
phase protein array,
The change in phosphorylation of mTORC1/2 target proteins and related signaling proteins at 

baseline and after therapy with TAK228 in optional pre- and post- therapy biopsy by utilizing reverse 
phase protein array
Rationale: (Be as concise as possible)
The mTOR pathway is an active target in multiple lymphoma subtypes. mTOR activity has been shown to 
be increased in nearly all lymphoma subtypes, including diffuse large B cell, mantle cell, and Hodgkin 

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lymphomas. The rapalog mTOR inhibitors (Temsirolimus and Everolimus) directly effect mTORC1 and 
have demonstrated promising efficacy in multiple lymphoma subtypes.
Temsirolimus is approved in Europe for mantle cell lymphoma, and has shown promising responses in 
diffuse large b-cell, follicular, and other indolent lymphomas. Everolimus has also shown promising 
responses in relapsed aggressive lymphoma. In addition, Everolimus has shown impressive response in 
relapsed/refractory Hodgkin lymphoma.
It is now known that inhibition of mTORC1, although effective for a portion of patients with lymphoma, 
leads to transient benefit at best, and perhaps even tumor growth for some cancers. Demonstrating the 
complexity of the crosstalk found in this pathway, mTORC1 inhibition can lead to activation of the PI3K 
pathway due to mTORC2 negative feedback, resulting in phosphorylation of Akt.
We believe inhibition of both mTORC1 and mTORC2 with TAK228 may result in a significant 
improvement in the efficacy seen to date with mTORC1 inhibitors in lymphomas. This clinical trial is 
based on: 1) the known promising activity of mTORC1 inhibitors in various subtypes of lymphomas, 2) the 
known escape/resistance mechanism that cancer utilizes to overcome mTORC1 inhibitor via mTORC2 
stimulation of Akt, and 3) the early signal of excellent tolerance and efficacy of TAK228 in clinical trials 
thus far.
It is our hypothesis that TAK228 will result in response rates higher than previously seen with rapalogs, 
with acceptable tolerability. The goal of our trial is to identify lymphoma subtypes with high response rates 
for future clinical trials, either combined with current standard therapies or with novel targeted agents.
It is currently difficult to predict which patients will have response to mTOR pathway directed therapies 
due to lack of actionable biomarkers. It is possible to assess for the activity of mTOR inhibition by 
evaluation of phosphorylation of downstream targets of mTOR, such as S6K and 4EBP1.To evaluate the 
baseline phosphorylation and effect of TAK228 on these markers, we propose to collect peripheral blood 
mononuclear cells and archival tissue blocks from patients enrolled on trial for correlative studies. The 
peripheral blood mononuclear cells will be evaluated as a surrogate for mTORC1/2 inhibiton and Akt 
phosphorylation after exposure to TAK228 via reverse phase protein array (RPPA). For the list of the 217 
currently utilized antibodies in the MD Anderson RPPA platform. Archival tumor blocks will be stored for 
attempted correlation of clinical responders vs non-responders with genomic assessment.
It has recently been reported that mutations of the MTOR may activate the pathway and thus predict 
clinical response to mTOR inhibitors. Patients with available archival tissue will undergo an evaluation for 
the presence of an MTOR mutation which could serve as a potential biomarker in future clinical trials.
Eligibility: (List All Criteria)
Inclusion:
1)
Each patient must meet all of the following inclusion criteria to be enrolled in the study: 1. Male or 
female patients 18 years or older.
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 

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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 togther; 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 Cockroft-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:
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.

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8)
Poorly controlled diabetes mellitus defined as HbA1c > 7%; subjects with a history of transient 
glucose intolerance due to corticosteroid administration are allowed in this study if all other 
inclusion/exclusion criteria are met;
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).
12)
Treatment with strong inhibitors and/or inducers of cytochrome P450 (CYP) 3A4, CYP2C9 or 
CYP2C19 within 1 week preceding the first dose of study drug.
13)
Patients receiving systemic corticosteroids (either IV or oral steroids, excluding inhalers or 
low-dose hormone replacement therapy as defined no greater than 20mg of prednisone daily) within 1 
week before administration of the first dose of study drug.
14)
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central 
nervous system disease, active infection, or any other condition that could compromise participation of 
the patient in the study.
15)
Central nervous system (CNS) lymphoma.
16)
Known human immunodeficiency virus infection.
17)
Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
18)
Diagnosed or treated for another malignancy within 2 years before administration of the first dose 
of study drug, or previously diagnosed with another malignancy and have any evidence of residual 
disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they 
have undergone complete resection
19)
Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within 7 days before 
receiving the first dose of study drug
Are patients <18 years of age eligible to participate in this study?  
Yes
No
Studies that include children must meet the criteria for inclusion.
http://www.fda.gov/ohrms/dockets/AC/04/briefing/4028B1_05_NIH-Inclusion%20of%20Children.doc
http://www.hhs.gov/ohrp/policy/populations/children.html

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Studies that exclude children must have appropriate justification.  Please select all that 
apply:
Phase I or Phase II study targeting cancer that is very unusual in pediatrics (e.g., prostate, lung, 
breast, chronic lymphocytic leukemia, etc.)
Are participants >65 years of age eligible to participate in this study?  
Yes
No
Are pregnant women eligible to participate in this study?
Yes
No
Will the recruitment population at M. D. Anderson include persons who are incarcerated at time of 
enrollment (e.g., prisoners) or likely to become incarcerated during the study?
Yes
No
Disease Group:
Lymphoma
Treatment Agents/Devices/Interventions:
TAK228
Proposed Treatment/Study Plan:
Is treatment assignment randomized?
Yes
No
Is this a blinded or double-blinded study?
Yes
No
TAK228 milled API will be administered once daily at approximately the same time on each scheduled 
dosing day and not to take more than the prescribed dose at any time. It is recommended that each dose 
of TAK228 be given orally with 8 ounces (240 mL) of water. TAK228 should be administered on an empty 
stomach, and patients should be instructed to refrain from eating or drinking (aside from water and 
prescribed medications) for 2 hours before and 1 hour after each dose. Cycles are repeated every 28 
days.
Screening Evaluation
A history and physical examination, including performance status evaluation, height, weight, and vital 
signs, should be performed within 28 days prior to the first dose of TAK228.
The following laboratory studies should be performed within 3 days prior to the first dose of TAK228 – 
CBC with differential, Serum chemistries – sodium (Na), potassium (K), chloride (Cl), glucose, 
bicarbonate (CO2), blood urea nitrogen (BUN), creatinine (Cr), calcium (Ca), magnesium (Mg), 
phosphorus, total protein, albumin, alkaline phosphatase, aspartate transaminase (AST), alanine 
transaminase (ALT), total bilirubin, direct bilirubin, uric acid, lactate dehydrogenase (LDH), Beta-2 
microglobulin, prothrombin time (PT/INR), partial thromboplastin time (PTT), hemoglobin A1c, and urine 
analysis, and a fasting serum glucose, triglycerides, cholesterol panel, and serum Beta-HCG in women of 
child-bearing potential. Fasting is defined as nothing to eat for at least 4-6 hours before blood draw.
ECHO or MUGA performed. 
Quantitative immunoglobulins (IgG, IgA, and IgM) within 28 days prior to the first dose of TAK228.

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HIV 1 and 2 antibody, Hepatitis C viral antibody, Hepatitis B surface antigen, Hepatitis B core antibody 
within 28 days prior to the first dose of TAK228.
The following staging studies should be performed within 28 days prior to the first dose of TAK228 – CT 
scans of neck, chest, abdomen, and pelvis; Chest X-ray – PA and lateral; and unilateral bone marrow 
biopsy and unilateral bone marrow aspirate.  An optional PET/CT scan may be obtained within 28 days 
prior to the first dose of TAK228 at the discretion of the treating physician.
An electrocardiogram will be obtained within 28 days prior to the first dose of TAK228.
For correlative studies, an optional 10 ml of blood sample [2 heparin containing green top tubes (5 
ml/tube)] will be collected within 3 business days prior to the first dose of TAK228. These samples will be 
transported within 4 hours of collection to the RPPA Core Laboratory Facility and/or Lymphoma Tissue 
Bank, depending on time of collection, at M. D. Anderson Cancer Center (MDACC). Blood from green top 
tubes will be processed for isolation of peripheral blood mononuclear cells (PBMC) using standard 
laboratory protocols.
For correlative studies, an optional archival tumor FFPE biopsy material collection will be occur for 
analysis of mutations in MTOR.
For correlative studies, an optional biopsy will be collected within 28 days prior to the first dose of 
TAK228 for analysis of phosphorylation in mTOR and related proteins if the patient has a tumor deemed 
to be safely accessable by the treating physician.
EVALUATION DURING STUDY 
During the first cycle, patients will be evaluated by the treating physician in the clinic prior to the start of 
TAK228 (within 3 business days). A relevant history and physical examination, including performance 
status evaluation and vital signs, will be recorded within 3 business days of the first dose of TAK228. 
Patients will subsequently be assessed by the medical team on days 8, 15, and 22 (within 3 business 
days). At these weekly assessments, a relevant history and physical examination will be recorded. 
Toxicities will be graded according to the NCI CTC v4.0 during these visits.
For all cycles beyond cycle 1, patients will be evaluated by the treating physician in the clinic prior to each 
cycle of TAK228 (within 3 business days). A relevant history and physical examination, including 
performance status evaluation and vital signs, will be recorded within 3 business days of each dose of 
TAK228. Toxicities will be graded according to the NCI CTC v4.0 during these visits
The following laboratory studies should be performed within 3 business days prior to each cycle of 
TAK228 – CBC with differential, Serum chemistries - Na, K, Cl, CO2, BUN, Cr, Ca, Mg, phosphorus, total 
protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin, direct bilirubin, urinalysis, uric acid, 
PT/PTT/INR and LDH, and a fasting serum glucose, triglycerides, cholesterol panel, and serum Beta- 
HCG in women of child-bearing potential. 
During the first 2 cycles of therapy, patients will monitor their glucose at least once daily in a fasting state 
via a provided glucometer. All patients will self monitor  their glucose daily in a fasting state approximately 
the same time each day, and  if directed by the clinical trial team may require monitoring more than once 
per day. If no irregularities in the fasting blood glucose level are observed during a minimum of 2 
consecutive months, then the frequency of in-home fasting blood glucose testing can be reduced to a 
minimum frequency of once weekly, depending on the investigator’s judgement and approval. Fasting is 
defined as nothing to eat for at least 4‐6 hours before blood draw.
During the first cycle of TAK228, the following laboratory studies should be performed on day 15 (within 3 
business days) - CBC with differential, Serum chemistries - Na, K, Cl, CO2, BUN, Cr, Ca, Mg, 
phosphorus, total protein, albumin, alkaline phosphatase, AST, ALT, total bilirubin, uric acid, and LDH, 
and a fasting serum glucose, trigylcerides, cholesterol panel.Fasting is defined as nothing to eat for at 

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least 4‐6 hours before blood draw.
Hemoglobin A1c should be obtained prior to cycle 1 day 1, cycle 3 day 1, cycle 6 day 1, cycle 9 days 1 
and cycle 12 day 1.
An electrocardiogram will be obtained pre-dose (within 28 business days) prior to start of cycle 1 and 
within 3 days of starting each subsequent cycle.
Evaluation At Completion of Study

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Study Enrollment:

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The study population for this research will consist of participants from:
Only at MDACC
Estimated Accrual:
Total Accrual at MDACC:
Phase II: Maximum 75, Minimum 45
Estimated monthly accrual at MDACC:
3
Screening Accrual:
Does this study include a screening component?
No
Accrual Comments:
This is an open label, phase II clinical trial to evaluate the safety and efficacy of TAK228 in patients with 
relapsed lymphoma. The maximum sample size is 75 and the minimum samples size is 24 for Phase II.
Is this an NCI-Cancer Therapy Evaluation Protocol (CTEP)?
No
Is this an NCI-Division of Cancer Prevention Protocol (DCP)?
No
Statistical Considerations:
Phase II cohort definitions and expectations
Cohort A

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Cohort I
Cohort H
Phase II design:
For each of the patient cohort, the overall response (OR) at two cycles and dose modifications required 
based upon toxicity (referred to below as reason for dose modification) at one cycle will be monitored. 
Simultaneously using Bayesian stopping boundaries calculated based on Beta-Binomial distributions.  
Independence was assumed between OR and Reason for dose modification.
For each of the patient cohort, the overall response (OR) at two cycles and dose modifications required 
based upon toxicity (referred to below as reason for dose modification) at one cycle will be monitored. 
Simultaneously using Bayesian stopping boundaries calculated based on Beta-Binomial distributions.  
Independence was assumed between OR and reason for dose modification.
For cohorts A) and H), TAK228 will be considered promising if it yields an OR rate of 35% at two  cycles 
and a reason for dose modification rate of 30% at one cycle.  A sample size of 25 in each patient cohort 
ensures that, if the cohort is not terminated early, a posterior 90% credibility interval for overall response 
rate will have width of 0.297 at most, under the assumption of a 35% of OR rate. The prior  probabilities 
of OR and reason for dose modification for the experimental regimen are modeled by beta distributions (
Beta(0.7,1.3) and Beta(0.6,1.4), respectively).  Denoting probabilities of OR rate and reason for dose 
modification rate by (pOR , pReason for dose modification) Confidential, the following decision criteria will 
be applied: Stop the trial if Prob( pOR <  35% | data) > 0.95 or Prob( pReason for dose modification 
>30% | data)>0.95.
Patients will be monitored by a cohort size of 5 after the first 15 patients according to the following 
stopping boundaries for OR at two cycles and reason for dose modification at one cycle.  If the number of 
responses required for moving the trial to next stage has not been achieved, the patient enrollment will be 
halted until enough responses observed.

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Analysis Plan
Population for Analysis
Efficacy Analysis

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Safety Analysis
Toxicity evaluation will be based on the incidence of severity and type of adverse events (including physical and 
laboratory). At each cycle clinic visit, patients will have vital signs (temperature, blood pressure, heart rate, and 
weight) measured, ECOG performance status assessed, be asked about all toxicities they have suffered, and 
undergo a physical exam. In addition, routine clinical laboratory testing (complete blood count, electrolytes, 
kidney and liver related labs) will be performed.
Does this protocol include a dose expansion component?
No
Data Safety Monitoring Board / DSMB at MDACC:
Select the name of the data safety monitoring board (DSMB) monitoring this protocol:
Not Applicable
Please explain:
This protocol is neither randomized nor blinded.
Protocol Monitoring:
Does this protocol have a schedule for interim and final analysis?
Yes
Provide a summary or schedule of interim analysis.
Safety and non-binding efficacy data will be reviewed after 5, 10, 15, 20,and 25 patients have completed 
all 
courses of TAK228, however, accrual will continue while this analysis is pending. If there is unacceptable 
study  drug-related toxicity, the study will be placed on hold and no further treatment  of any patient will 
occur until further review and discussion with the FDA. The study may proceed after appropriate 
amendments have been made to address the observed study drug-related toxicity. It is anticipated that a 
preliminary  report of efficacy and safety may be presented at a national meeting such as the ASCO 
Annual Meeting, including the trials in progress poster session, or the American Society of Hematology 
Annual Meeting.
Protocol Monitoring Plan:
A Bayesian dose escalation program  and efficacy/toxicity monitoring to allow for cohorts which do not 
meet our efficacy targets to close early.
Intellectual Property:
1.
Does this study include any agents, devices, or radioactive compound (or 
drug) manufactured at  MD Anderson Cancer Center or by a contract 
No

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manufacturer?
Investigational New Drugs (IND):
Does this protocol require an IND?
Yes
Who is the IND Holder/Regulatory Sponsor?
UT MDACC
IND Number:
129,368
Please "Compose" an Investigator’s Brochure Cover Letter.  For technical assistance, contact the PDOL 
Help Desk, 713-745-7365.
Investigational Device (IDE):
Does this study utilize an Investigational Device?
N/A
Immunotherapy
Is this an Immunotherapy study?
No
Moon Shots Program
Will your protocol be funded by the Moon Shots Program? No
Sponsorship and Support Information:
Does the Study have a Sponsor, Supporter or Granting Agency?
Yes
Sponsor Name:
Takeda Pharmaceuticals, Inc.
Support Type:
Industry Funding
Agent Name(s): TAK228
This Sponsor/Supporter/Granting Agency will receive data.
Regulatory Requirements
Radioactive Material:
Does this study involve the administration of radioisotopes or a
radioisotope labeled agent?
Click here  for help
N/A
Biosafety:
Does this study involve the use of Recombinant DNA Technology such as 
No

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DNA nucleotide, RNA nucleotide, genetically modified human cells, animal 
cells, bacteria, or virus? 
Does this study involve the use of organisms that are infectious to humans?
No
Does this study involve human/animal tissue other than blood derived 
hematopoietic stem cells?
N/A
Questions should be addressed to the Transfusion Medicine Tissue Coordinator at 713-792-8630.
Laboratory Tests:
Is there any biomarker testing in this study being used to determine patient/participant eligibility, 
treatment assignment, or management of patient/participant care?
Yes
No
Not Applicable For This Protocol
Manufacturing:
Will you manufacture in full or in part (split manufacturing) a drug or biological 
product at the M. D. Anderson Cancer Center for the proposed clinical study?
No
Student/Trainee Information:
Is this research being conducted as a partial fulfillment for completion of a degree?
No