NCT02393209 is a Phase 1, PHASE2 clinical trial of Docetaxel in Non-small Cell Lung Cancer, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT02393209?

NCT02393209 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT02393209?

Interventions in NCT02393209: Docetaxel, TAK-117.

What condition does NCT02393209 study?

NCT02393209 studies Non-small Cell Lung Cancer.

Is NCT02393209 still recruiting?

NCT02393209 is currently terminated. Last updated 7 February 2018.

Are results published for NCT02393209?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-02-07 · How we verify

NCT02393209

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Terminated Phase 1, PHASE2 Results posted Last updated 7 February 2018

What this trial tests

Phase 1, PHASE2 trial testing Docetaxel in Non-small Cell Lung Cancer in 14 participants. Terminated before completion.

Timeline

3 June 2015

Primary endpoint
12 January 2017

20 January 2017

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	14
Start date	3 June 2015
Primary completion	12 January 2017
Estimated completion	20 January 2017
Sites	11 locations across Netherlands, Canada, United States

Drugs / interventions tested

Docetaxel (Docetaxel) — full drug profile →
TAK-117 — full drug profile →

Conditions studied

Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1b Primary · Cycle 1 (Up to Day 21)

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 Ras

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1

Maximum Tolerated Dose (MTD) of TAK-117 in Combination With Docetaxel 36 mg/m^2 in Phase 1b Primary · Cycle 1 (Up to Day 21)

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 na

Group	Value	95% CI
TAK-117 + Docetaxel	300

Recommended Phase 2 Dose of TAK-117 in Phase 1b Primary · Cycle 1 (Up to Day 21)

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

Group	Value	95% CI
TAK-117 + Docetaxel	200

Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 1b Secondary · First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

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.

Bradycardia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	0

Sinus tachycardia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1

Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 1b Secondary · First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

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).

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1

Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 1b Secondary · First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

A standard 12-lead ECG was performed.

Bradycardia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	0

Tachycardia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1

Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 1b Secondary · First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)

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

Anemia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	2
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	2

Hypokalemia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3

Hypomagnesemia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3

Hypophosphatemia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3

Aspartate aminotransferase increased

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	2

Febrile neutropenia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	2

Hyponatremia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	2

Hyperglycemia

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	0
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	2

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b Secondary · From first dose of study drug to 30 days after last dose of study drug (Up to Day 223)

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 / inc

TEAEs

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	6
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	8

SAEs

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	5
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	6

TAK-117 Plasma Concentration in Phase 1b Secondary · Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose

Predose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	114.00	± 254.912
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	0.00	± 0.000

0.5 Hour Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1208.60	± 1080.782
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	847.39	± 966.346

1 Hour Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1907.00	± 1307.124
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1973.29	± 1688.210

2 Hours Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	2597.83	± 1612.233
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3021.43	± 2162.417

4 Hours Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	2477.50	± 1407.465
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	4185.71	± 2156.439

6 Hours Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	2143.00	± 1290.395
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3648.57	± 1636.892

8 Hours Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	1902.50	± 1210.553
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	3677.14	± 1941.020

24 Hours Postdose

Group	Value	95% CI
Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2	652.17	± 472.315
Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2	1771.57	± 1347.864

Adverse events — posted to ClinicalTrials.gov

Time frame: First dose of study drug through 30 days from the last dose (up to Day 223). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1 - TAK-117 200 mg + Docetaxel 36 mg/m^2

Serious: 5/6 (83%)

Deaths: 1/6

Phase 1 - TAK-117 300 mg + Docetaxel 36 mg/m^2

Serious: 6/8 (75%)

Deaths: 3/8

Serious adverse events (20 terms)

Reaction	System	Phase 1 - TAK-117 200 mg +…	Phase 1 - TAK-117 300 mg +…
Pneumonia	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Bacterial sepsis	Infections and infestations	—	—
Legionella infection	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Gastric haemorrhage	Gastrointestinal disorders	—	—
Odynophagia	Gastrointestinal disorders	—	—
Oesophagitis	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—
Cardiogenic shock	Cardiac disorders	—	—
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Postmenopausal haemorrhage	Reproductive system and breast disorders	—	—

Other adverse events (70 terms — click to expand)

Reaction	System	Phase 1 - TAK-117 200 mg +…	Phase 1 - TAK-117 300 mg +…
Nausea	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Oedema peripheral	General disorders	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Vision blurred	Eye disorders	—	—
Dizziness	Nervous system disorders	—	—
Hypoaesthesia	Nervous system disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Bradycardia	Cardiac disorders	—	—
Sinus tachycardia	Cardiac disorders	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—
Nail discolouration	Skin and subcutaneous tissue disorders	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Anxiety	Psychiatric disorders	—	—
Depression	Psychiatric disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Trismus	Musculoskeletal and connective tissue disorders	—	—
Pneumonia	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Oral candidiasis	Infections and infestations	—	—
Pseudomonas infection	Infections and infestations	—	—

Most-reported serious reactions: Pneumonia, Diarrhoea, Nausea, Vomiting, Respiratory failure, Febrile neutropenia, Dehydration, Bacterial sepsis.

Data from ClinicalTrials.gov NCT02393209 adverse events section.

Sponsor's own description

The purpose of this study is to determine the recommended phase 2 dose (RP2D) of TAK-117 when administered in combination with docetaxel in participants with non-small cell lung cancer (NSCLC) and to evaluate efficacy, safety, and tolerability of TAK-117 administered alone and in combination with docetaxel at the RP2D in participants with locally advanced or metastatic non-small cell lung cancer.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging therapeutic agents for lung cancer.
Dholaria B, Hammond W, Shreders A, Lou Y. · · 2016 · cited 66× · PMID 27938382 · DOI 10.1186/s13045-016-0365-z
Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development.
Ahmed MA, Patel C, Drezner N, Helms W, et al · · 2020 · cited 9× · PMID 31674150 · DOI 10.1111/cts.12703

Verify or expand the search:

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Trials testing the same drug.

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Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

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NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02393209 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc.
Last refreshed: 7 February 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02393209.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing