NCT03708211 is a Phase 1 clinical trial of TAK-931 PIC in Neoplasms, Advanced Solid, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT03708211?

NCT03708211 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT03708211?

Interventions in NCT03708211: TAK-931 PIC, TAK-931 Tablet, Esomeprazole.

What condition does NCT03708211 study?

NCT03708211 studies Neoplasms, Advanced Solid.

Is NCT03708211 still recruiting?

NCT03708211 is currently completed. Last updated 29 December 2020.

Are results published for NCT03708211?

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

Last reviewed 2020-12-29 · How we verify

NCT03708211

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

A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors

Completed Phase 1 Results posted Last updated 29 December 2020

What this trial tests

Phase 1 trial testing TAK-931 PIC in Neoplasms, Advanced Solid in 20 participants. Completed in 3 December 2019.

Timeline

28 March 2019

Primary endpoint
3 December 2019

3 December 2019

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	20
Start date	28 March 2019
Primary completion	3 December 2019
Estimated completion	3 December 2019
Sites	4 locations across Netherlands

Drugs / interventions tested

TAK-931 PIC — full drug profile →
TAK-931 Tablet — full drug profile →
Esomeprazole (esomeprazole) — full drug profile →

Conditions studied

Neoplasms, Advanced Solid — all drugs for Neoplasms, Advanced Solid →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Neoplasms, Advanced Solid. 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.

Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-931 Tablets in Reference to PIC Primary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length is equal to [=] 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	251.45	± 41.91
TAK-931 80 mg Tablet	270.09	± 36.44

Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 Tablets in Reference to PIC Primary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	1869.0329	± 44.7484
TAK-931 80 mg Tablet	1898.9016	± 45.2980

Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-931 Tablets in Reference to PIC Primary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	1901.1447	± 44.6999
TAK-931 80 mg Tablet	1925.8648	± 45.2966

Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931 as PIC and Tablets Secondary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	1.6830	0.917 – 4.117
TAK-931 80 mg Tablet	1.9830	0.483 – 4.033

Part 1, CL/F: Oral Clearance for TAK-931 Secondary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	42.0799	± 44.6999
TAK-931 80 mg Tablet	41.5397	± 45.2966

Part 1, T1/2z: Terminal Disposition Phase Half-life for TAK-931 Secondary · Cycle 0 Days 1 and 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle 0 length = 16 days)

Group	Value	95% CI
TAK-931 80 mg PIC	7.3250	± 25.4121
TAK-931 80 mg Tablet	7.3683	± 18.6369

Part 1: Overall Response Rate (ORR) Secondary · Baseline up to 8 months

ORR was defined as the percentage of participants achieving complete response (CR) and partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), CR was defined as disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD.

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	0
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	0

Part 1: Progression-free Survival (PFS) Secondary · From the date of randomization to the date of first documentation of PD or death due to any cause, whichever occurred first (up to 8 months)

PFS was defined as the time from the date of randomization to the date of first documentation of PD or death due to any cause, whichever occured first. Per RECIST V1.1, PD was defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeter (mm).

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	1.9	1.7 – 2.8
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	2.0	1.4 – 3.6

Part 1: Disease Control Rate (DCR) Secondary · Baseline up to 8 months

DCR was defined as the percentage of participants with CR, PR plus stable disease (SD) greater than or equal to (\>=) 1 post baseline computed tomography (CT) scan evaluation from treatment initiation to qualify for DCR. Per RECIST v 1.1, CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the LD of lesions, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, t

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	18.2
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	25.0

Part 1: Percentage of Participants With Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and TEAEs Leading to Discontinuation or Dose Modification Secondary · From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)

SAEs

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	16.7
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	25.0

TEAEs

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	91.7
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	100

TEAEs Leading to Discontinuation or Dose Modification

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	0

Part 1: Percentage of Participants With Grade 3 or Higher TEAEs Secondary · From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)

An AE was defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 s

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	41.7
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	37.5

Part 1: Percentage of Participants With Shift From Baseline Values to Post-baseline Values in Laboratory Parameters Secondary · From the start of the study drug up to Day 30 after the last dose of study drug (up to 8 months)

Eosinophils: Grade 0 to Grade 0

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	83.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	87.5

Eosinophils: Grade 0 to Grade 1

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	0.0

Eosinophils: Grade 1 to Grade 0

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	12.5

Hemoglobin: Grade 0 to Grade 0

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	33.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	0.0

Hemoglobin: Grade 0 to Grade 1

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	12.5

Hemoglobin: Grade 1 to Grade 0

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	0.0

Hemoglobin: Grade 1 to Grade 1

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	41.7
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	50.0

Hemoglobin: Grade 1 to Grade 2

Group	Value	95% CI
Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet	8.3
Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC	12.5

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs are adverse events (AE) that started after the first dose of study drug up to 30 days after the last dose of study drug (up to 8 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1, Sequence A: TAK-931 80 mg PIC + TAK-931 80 mg Tablet

Serious: 2/12 (17%)

Deaths: 0/12

Part 1, Sequence B: TAK-931 80 mg Tablet + TAK-931 80 mg PIC

Serious: 2/8 (25%)

Deaths: 1/8

Serious adverse events (4 terms)

Reaction	System	Part 1, Sequence A: TAK-93…	Part 1, Sequence B: TAK-93…
Ileus	Gastrointestinal disorders	—	—
Bundle branch block left	Cardiac disorders	—	—
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Cholecystitis infective	Infections and infestations	—	—

Other adverse events (48 terms — click to expand)

Reaction	System	Part 1, Sequence A: TAK-93…	Part 1, Sequence B: TAK-93…
Fatigue	General disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Weight decreased	Investigations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Neutrophil count decreased	Investigations	—	—
Platelet count decreased	Investigations	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Oral candidiasis	Infections and infestations	—	—
Otitis media	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Rash pustular	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Aphasia	Nervous system disorders	—	—
Disturbance in attention	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Facial nerve disorder	Nervous system disorders	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Ileus, Bundle branch block left, Rectal cancer, Cholecystitis infective.

Data from ClinicalTrials.gov NCT03708211 adverse events section.

Sponsor's own description

The purpose of this study is to estimate the relative bioavailability of TAK-931 tablets in reference to powder-in capsule (PIC) and to assess the effect of food and esomeprazole on the pharmacokinetics (PK) of TAK-931 as a tablet.

Publications & conference data

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

Drug repurposing for cancer therapy.
Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
Safety, Tolerability, and Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Inhibitor, in Patients with Advanced Solid Tumors: A Phase I First-in-Human Study.
Kuboki Y, Shimizu T, Yonemori K, Kojima T, et al · · 2022 · cited 11× · PMID 36970056 · DOI 10.1158/2767-9764.crc-22-0277
Population Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Kinase Inhibitor, in Patients With Advanced Solid Tumors.
Zhou X, Ouerdani A, Diderichsen PM, Gupta N. · · 2022 · cited 3× · PMID 34564871 · DOI 10.1002/jcph.1974
A phase 1 open-label study to assess the relative bioavailability of TAK-931 tablets in reference to powder-in-capsule in patients with advanced solid tumors.
Steeghs N, Pruis M, van Herpen C, Lu V, et al · · 2023 · cited 2× · PMID 36409435 · DOI 10.1007/s10637-022-01318-3
Assessment of Effects of Investigational TAK-931, an Oral Cell Division Cycle 7 Kinase Inhibitor on the QTc Intervals in Patients With Advanced Solid Tumors.
Zhou X, Diderichsen PM, Gupta N. · · 2022 · cited 2× · PMID 35187855 · DOI 10.1002/cpdd.1075

Verify or expand the search:

Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

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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 NCT03708211 (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: 29 December 2020

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/NCT03708211.

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