Trial · NCT03449030
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
NCT03449030, Phase 1, Terminated, Millennium Pharmaceuticals, Inc.; results first posted 2021-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC). Trials, record NCT03449030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03449030
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
- NCT number
- NCT03449030
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 31 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Gastrointestinal Neoplasms; Esophageal, Stomach, Pancreas, Colon Neoplasms; Malignant Tumors of Digestive Organ; Advanced Gastrointestinal Malignancies
- Interventions
- TAK-164, 89Zr-TAK-164
- First posted
- 2018-02-28
- Last updated
- 2021-03-22
- Other registries' IDs
- eudract:2018-002214-12
- Results first posted
- 2021-03-22
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | Baseline up to Month 22 | DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5. DLT was defined as any of the following adverse events (AEs) that occurred and were considered by the investigator to be related to therapy with study drug: hematologic toxicities were, Grade 4 neutropenia (absolute neutrophil count \[ANC\] less than (\<) 500 cells/cubic millimeter \[mm\^3\]), thrombocytopenia (platelets \<25,000/mm\^3), febrile neutropenia (ANC \<1000/mm\^3) with fever (greater than \[\>\] 38.3 degree Celsius or sustained temperature of greater than or equal to (\>=) 38 degree Celsius, Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time, Grade 3 or greater nausea and/or emesis that occurs despite the use of optimal anti-emetic prophylaxis and Grade 3 or greater diarrhea that occurs despite optimal supportive care measures and any other Grade 3 or greater nonhematologic toxicity except brief (\<1 week) Grade 3 fatigue. |
| Primary | Percentage of Participants With Adverse Events (AEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | |
| Primary | Percentage of Participants With Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: Mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: Death related AE. Higher grade indicates more severe condition. |
| Primary | Percentage of Participants With Drug-related AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | |
| Primary | Percentage of Participants With Drug-related Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | AE Grades were evaluated as per NCI CTCAE, version 5. Graded from Grade 1: mild asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4: Life-threatening consequences; urgent intervention indicated, Grade 5: death related AE. Higher grade indicates more severe condition. |
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | |
| Primary | Percentage of Participants With AEs Leading to Discontinuation | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | |
| Primary | Recommended Phase 2 Dose (RP2D) of TAK-164 | Baseline up to Month 22 | RP2D was the highest safe dose that could be applied to the expansion phase. |
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | |
| Secondary | Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicities (DLTs) | Baseline up to Month 22 | The safety population was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Adverse Events (AEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Drug-related AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Drug-related Grade 3 or Above AEs | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With AEs Leading to Discontinuation | From first dose of study drug up to 30 days following the last dose of study drug (up to 22 months) | The safety population was defined as all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | Pharmacokinetic (PK) analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. | ||
| SECONDARY | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-164 | Cycles 1 and 2 Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose (Cycle length = 21 days) | PK analysis was not conducted due to premature discontinuation of the study after completion of Part A and prior to start of Parts B (Expansion Cohort) and C (Imaging Substudy) because there was insufficient clinical benefit to participants at the selected RP2D dose in Part A. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group111
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.004 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.008 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.016 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.032 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.064 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.12 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.16 mg/kg | 0 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.19 mg/kg | 1 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.25 mg/kg | 2 | Participants | ||
| Number of Participants With Dose-limiting Toxicities (DLTs) | Part A: TAK-164 0.32 mg/kg | 0 | Participants |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: TAK-164 0.004 mg/kg | 1 | |
| Overall Study | STARTED | Part A: TAK-164 0.008 mg/kg | 1 | |
| Overall Study | STARTED | Part A: TAK-164 0.016 mg/kg | 1 | |
| Overall Study | STARTED | Part A: TAK-164 0.032 mg/kg | 5 | |
| Overall Study | STARTED | Part A: TAK-164 0.064 mg/kg | 7 | |
| Overall Study | STARTED | Part A: TAK-164 0.12 mg/kg | 7 | |
| Overall Study | STARTED | Part A: TAK-164 0.16 mg/kg | 2 | |
| Overall Study | STARTED | Part A: TAK-164 0.19 mg/kg | 3 | |
| Overall Study | STARTED | Part A: TAK-164 0.25 mg/kg | 3 | |
| Overall Study | STARTED | Part A: TAK-164 0.32 mg/kg | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,320
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.004 mg/kg | 0 | 1 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.008 mg/kg | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.016 mg/kg | 1 | 1 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.032 mg/kg | 3 | 5 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.064 mg/kg | 2 | 7 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.12 mg/kg | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.16 mg/kg | 1 | 2 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.19 mg/kg | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.25 mg/kg | 1 | 3 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Part A: TAK-164 0.32 mg/kg | 0 | 1 | 0 |
1 to 10 of 1,320Source ClinicalTrials.gov
See all 1,320 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: TAK-164 0.004 mg/kg | 0 | 1 |
| Total, all-cause mortality | Part A: TAK-164 0.008 mg/kg | 0 | 1 |
| Total, all-cause mortality | Part A: TAK-164 0.016 mg/kg | 0 | 1 |
| Total, all-cause mortality | Part A: TAK-164 0.032 mg/kg | 0 | 5 |
| Total, all-cause mortality | Part A: TAK-164 0.064 mg/kg | 1 | 7 |
| Total, all-cause mortality | Part A: TAK-164 0.12 mg/kg | 0 | 7 |
| Total, all-cause mortality | Part A: TAK-164 0.16 mg/kg | 0 | 2 |
| Total, all-cause mortality | Part A: TAK-164 0.19 mg/kg | 1 | 3 |
| Total, all-cause mortality | Part A: TAK-164 0.25 mg/kg | 0 | 3 |
| Total, all-cause mortality | Part A: TAK-164 0.32 mg/kg | 0 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03449030
GET https://conductscience.org/api/trials/v1/NCT03449030/results?page=2