Docetaxel With or Without TAK-117 (MLN1117) in Participan... | NCT02393209

ID	Type	Description	Link
2014-004281-25	EudraCT Number
U1111-1160-1736	Registry Identifier	UTN (WHO)

Description Module

Detailed Description

The drug being evaluated in this study is called TAK-117. TAK-117 is tested in combination with docetaxel versus docetaxel alone for the treatment of non-small cell lung cancer (NSCLC).

This study consisted of 2 phases:

Phase 1b - dose escalation phase
Phase 2 - expansion phase.

The study enrolled 14 patients with NSCLC who have been treated with multiple prior lines of therapies will be enrolled for Phase 1b. The participants will receive docetaxel (36 mg/m^2) intravenous (IV) and TAK-117 tablets, orally administered, once daily in 21-day dosing cycles. The TAK-117 dose will be escalated until recommended Phase 2 dose (RP2D) is determined.

Each part of the adaptive Phase 2 portion of the study is designed as a stand-alone, randomized study evaluating PFS as the primary efficacy measure in a total of 60 participants between the 2 treatment arms: TAK-117 plus docetaxel versus docetaxel alone. An event-driven analysis of PFS will be performed after each part of Phase 2. On the basis of the PFS analysis of the preceding part of the study, the study may be stopped for efficacy or futility, or proceed to the next part. However, Phase 2 of the study was cancelled.

Study drug will be administered in 21-day dosing cycles. During each phase of the study, participants will be treated with a maximum of 9 cycles of either docetaxel alone or docetaxel plus TAK-117. Subsequently, participants treated with docetaxel plus TAK-117 may continue to receive TAK-117 monotherapy until progression of disease, occurrence of unacceptable toxicities or death.

The maximum duration of treatment for participants will be 12 months unless it is determined that a participant would derive benefit from continued treatment beyond 12 months. Participants will continue to be followed after discontinuation of study drug to collect PFS and OS data. Participants may withdraw from therapy at any time.

This multicenter trial will be conducted in North America. The overall time to participate in this study is up to 24 months.

Label	Type	Description	Intervention Names
TAK-117 200 mg + Docetaxel (36 mg/m^2)	Experimental	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up ro Cycle 9 (approximately 189 days).	Drug: Docetaxel Drug: TAK-117
TAK-117 300 mg + Docetaxel 36 mg/m^2	Experimental	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).	Drug: Docetaxel Drug: TAK-117
Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	Experimental	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.	Drug: Docetaxel Drug: TAK-117
Phase 2 - Docetaxel 75 mg/m^2	Experimental	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.	Drug: Docetaxel Drug: TAK-117

Name	Type	Description	Arm Group Labels	Other Names
Docetaxel	Drug	Docetaxel intravenous infusion	Phase 2 - Docetaxel 75 mg/m^2 Phase 2 - TAK-117 + Docetaxel 36 mg/m^2 TAK-117 200 mg + Docetaxel (36 mg/m^2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1b	DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.	Cycle 1 (Up to Day 21)
Maximum Tolerated Dose (MTD) of TAK-117 in Combination With Docetaxel 36 mg/m^2 in Phase 1b	The MTD is defined as the dose of TAK-117 in combination with docetaxel 36 mg/m^2 at which 1 of 6 evaluable participants experience DLT. DLT was evaluated according to NCI CTCAE version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.	Cycle 1 (Up to Day 21)
Recommended Phase 2 Dose of TAK-117 in Phase 1b	The recommended phase 2 dose was determined in Phase 1b based on participant dose-limiting toxicities and the maximum tolerated dose.	Cycle 1 (Up to Day 21)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 1b	Clinically significant change from baseline in vital sign measures will be assessed. Vital sign measurements included measurements of diastolic and systolic blood pressure, heart rate, and temperature.	First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).

- For Phase 2 of the study, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
Has experienced failure of at least 1 prior chemotherapy regimen:
- For Phase 2 of the study:
- Participants must have received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel-containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease (PD).
- A drug provided as maintenance therapy following cytotoxic chemotherapy will be considered to be part of that regimen.
- Participants who received prior therapy with paclitaxel as a part of the platinum-based doublet front-line regimen without PD on therapy.
- Participants who, after the front-line, platinum-based, non-docetaxel containing chemotherapy, have been treated with 1 line of nivolumab or other immune-checkpoint inhibitors but progressed on or after the therapy.
- For Phase 1b of the study: Participants who have experienced failure of multiple lines of prior chemotherapy are eligible.
- For Phase 2, has archived or fresh tumor biopsy samples (obtained during screening) sufficient for genotyping.
Has adequate organ function, before the first dose of study drug.
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 30 days (or longer, as mandated by local labeling) after the last dose of study drug, or agree to practice true abstinence.
Female participants must agree to not donate eggs (ova) during the course of this study and for 30 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling.
Male participants agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling, or agree to practice true abstinence.
Male participants must agree to not donate sperm during the course of the study and for 120 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling.
Has suitable venous access for the study-required blood sampling.
Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.
In the opinion of the investigator, the participant or legal guardian is capable of understanding and complying with protocol requirements for the duration of the study.

Exclusion Criteria:

Previous treatment with a PI3K or AKT inhibitor.
Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before the first administration of study drug, and the participant must have documented progressive disease.
Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
Has taken proton pump inhibitors within 7 days before the first administration of study drug.
Has a condition that requires the concomitant use of any of the protocol-excluded medications, supplements, or food products during the course of the study .
Has any clinically significant co-morbidities.
Has acute myocardial infarction within 6 months before starting study drug, current or history of New York Heart Association Class III or IV heart failure; evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiogram (ECG) evidence of acute ischemia or active conduction system abnormalities; Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period; or abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that in the opinion of the investigator are considered to be clinically significant.
Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
Has brain metastasis, unless has completed definitive therapy, is not on steroids, has a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and does not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Has active secondary malignancy that requires treatment.
Has any serious medical or psychiatric illness, including drug or alcohol abuse.
Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of TAK-117 and, for docetaxel, for as long as is mandated by local labeling.
Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before administration of the first dose of study drug.
Is unwilling or unable to abide by the requirements of the study.

Name	Affiliation	Role
Medical Director Clinical Science	Millennium Pharmaceuticals, Inc.	Study Director

ID	Title	Description
FG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
FG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Jan 12, 2018	Jan 12, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1b

DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.

The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.

Posted

Number

participants

Cycle 1 (Up to Day 21)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG0006 OG0018

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011

Primary

Maximum Tolerated Dose (MTD) of TAK-117 in Combination With Docetaxel 36 mg/m^2 in Phase 1b

The MTD is defined as the dose of TAK-117 in combination with docetaxel 36 mg/m^2 at which 1 of 6 evaluable participants experience DLT. DLT was evaluated according to NCI CTCAE version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.

Posted

Number

Cycle 1 (Up to Day 21)

ID	Title	Description
OG000	TAK-117 + Docetaxel	TAK-117 200 mg or 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).

Primary

Recommended Phase 2 Dose of TAK-117 in Phase 1b

The recommended phase 2 dose was determined in Phase 1b based on participant dose-limiting toxicities and the maximum tolerated dose.

Posted

Number

Cycle 1 (Up to Day 21)

ID	Title	Description
OG000	TAK-117 + Docetaxel	TAK-117 200 mg or 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).

Units	Counts
Participants	OG000

Primary

Progression-Free Survival (PFS) in Phase 2

PFS is defined as the time from the date randomization to the date of first documented progressive disease (PD) or death as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants

Secondary

Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 1b

Clinically significant change from baseline in vital sign measures will be assessed. Vital sign measurements included measurements of diastolic and systolic blood pressure, heart rate, and temperature.

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Number

participants

First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants

Secondary

Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 1b

Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Number

participants

First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Secondary

Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 1b

A standard 12-lead ECG was performed.

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Number

participants

First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants

Secondary

Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 1b

The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Number

participants

First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Number

participants

From first dose of study drug to 30 days after last dose of study drug (Up to Day 223)

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2

Secondary

Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 2

Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.

Data was not analyzed as Phase 2 of study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 2

Data was not analyzed as Phase 2 of study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants

Secondary

Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 2

Clinically significant changes from baseline in ECGs will be tabulated by time point including any unscheduled measurements.

Data was not analyzed as Phase 2 of study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 2

The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 2

Safety population was defined as all participants who received at least 1 dose of any study drug.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Secondary

Response Rate in Phase 2

Response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants

Secondary

Disease Control Rate in Phase 2

Disease control rate is defined as percentage of participants with CR + PR + stable disease (SD). According to RECIST: CR is defined as disappearance of all target lesions, PR is defined as 30% decrease in the sum of the longest diameter of target lesions and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants

Secondary

Duration of Response in Phase 2

The duration of response is defined as the time from the date of first documentation of a response to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Time to Progression in Phase 2

Time to progression is defined as the time from the date of randomization to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

Overall Survival (OS) in Phase 2

Overall survival is defined as the time from the date of randomization to the date of death.

Data was not analyzed as Phase 2 of the study was cancelled.

Posted

Approximately 12 months in Phase 2

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Secondary

TAK-117 Plasma Concentration in Phase 1b

The PK-evaluable population was defined as all participants for whom there are sufficient dosing and TAK-117 concentration-time data to permit non-compartmental PK analysis. Here 'Number Analyzed' are participants analyzed at the specific timepoint.

Posted

Mean

Standard Deviation

ng/mL

Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants

Secondary

Cmax: Maximum Observed Plasma Concentration for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and up to 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

AUCtau: Area Under the Concentration Time Curve From Time 0 to the Next Dose in Phase 1b for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and up to 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Phase 1b for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and up to 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

CL/F: Oral Clearance for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and up to 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

T1/2: Terminal Phase Elimination Half-life (T1/2) for TAK-117

This analysis was not performed due to lack of data.

Posted

Cycle 1 Day 1 pre-dose and up to 24 hours post-dose

ID	Title	Description
OG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
OG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).

Units	Counts
Participants	OG000

Secondary

TAK-117 Plasma Concentrations When Administered 1 Day After Docetaxel in Phase 2

Data was not analyzed as Phase 2 of study was cancelled.

Posted

1 day post docetaxel dose

ID	Title	Description
OG000	Phase 2 - TAK-117 + Docetaxel 36 mg/m^2	TAK-117 tablets, at the dose determined in the dose escalation phase, on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of a 21-day cycle plus Docetaxel 36 mg/m^2 IV infusion on Days 1 and 8 of a 21-day cycle.
OG001	Phase 2 - Docetaxel 75 mg/m^2	Docetaxel 75 mg/m^2, IV infusion once every 3 weeks (per approved prescribing information) with dosing on Day 1 of each 21-day cycle.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment		EG0002 affected6 at risk EG0011 affected8 at risk
Bacterial sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk
Legionella infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TAK-117 300 mg + Docetaxel and was not related.	EG0000 affected6 at risk EG0011 affected8 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0002 affected6 at risk EG0011 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0012 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0012 affected8 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0001 affected6 at risk EG0010 affected8 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment		EG0001 affected6 at risk EG0010 affected8 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment		EG0002 affected6 at risk EG0010 affected8 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TAK-117 300 mg + Docetaxel and was related.	EG0000 affected6 at risk EG0011 affected8 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment		EG0001 affected6 at risk EG0012 affected8 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TAK-117 200 mg + Docetaxel and was not related.	EG0001 affected6 at risk EG0010 affected8 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.0	Systematic Assessment		EG0001 affected6 at risk EG0010 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0012 affected8 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TAK-117 300 mg + Docetaxel and was not related.	EG0000 affected6 at risk EG0011 affected8 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment		EG0000 affected6 at risk EG0011 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vision blurred	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Bradycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Anxiety	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Trismus	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Oral candidiasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pseudomonas infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected8 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Alanine aminotransferase increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Blood cholesterol increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Ejection fraction decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Neutrophil count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Weight decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
White blood cell count decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0013 affected8 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Fatigue	General disorders	MedDRA 19.0	Systematic Assessment	EG0003 affected6 at risk EG0014 affected8 at risk
Oedema peripheral	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected8 at risk
Pyrexia	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected8 at risk
Chills	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0013 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0013 affected8 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0013 affected8 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0013 affected8 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0010 affected8 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0015 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0015 affected8 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0012 affected8 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected8 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected8 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected8 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		San Diego	California		United States

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).
BG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	TAK-117 200 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, intravenous (IV) infusion, on Days 1 and 8 of the 21-day cycle up to 9 cycles (approximately 189 days).	1	6	5	6	6	6
EG001	Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	TAK-117 300 mg, tablets, orally on Days 2, 3, 4, 9, 10, 11, 16, 17, and 18 of the 21-day cycle and docetaxel 36 mg/m^2, IV infusion, on Days 1 and 8 of the 21-day cycle up to 6 cycles (approximately 126 days).	3	8	6	8	8	8