Trial · NCT02391038
MLN0264 in Previously Treated Asian Participants With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C
NCT02391038, Phase 1, Terminated, Millennium Pharmaceuticals, Inc.; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MLN0264 in Previously Treated Asian Participants With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C. Trials, record NCT02391038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02391038
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MLN0264 in Previously Treated Asian Participants With Advanced Gastrointestinal Carcinoma or Metastatic or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Guanylyl Cyclase C
- NCT number
- NCT02391038
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 12 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
Advanced Gastrointestinal Carcinoma, Gastroesophageal Junction Adenocarcinoma, Recurrent Gastric Adenocarcinoma, Recurrent Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Recurrent Gastrointestinal Carcinoma
- Interventions
- MLN0264
- First posted
- 2015-03-18
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks) | |
| Primary | Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | |
| Primary | Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Phase 1: Up to Cycle 1 (3 weeks) | Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count\[ANC\]less than\[\<\]500 cells/millimeter\[mm\]\^3); \>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets \<25,000/mm\^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;\>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;\>=Grade 3 diarrhea despite optimal supportive care measures;any other \>=Grade 3 nonhematologic toxicity except brief(\<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (\>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other\>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. |
| Primary | Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation. |
| Primary | Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute \[bpm\]). |
| Primary | Phase 1- Recommended Phase 2 Dose (RP2D) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which \<=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than\<500 cells mm\^3;\>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets \<25,000/mm\^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;\>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;\>=Grade 3 diarrhea despite optimal supportive care measures;any other \>=Grade 3 nonhematologic toxicity except brief(\<1 week)Grade 3 fatigue;Inability to start next therapy cycle\>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other\>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy. |
| Primary | Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | |
| Primary | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks) | Safety population includes all participants who received any amount of study drug. | participants | NUMBER |
| PRIMARY | Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | Safety population included all participants who received any amount of study drug. | participants | NUMBER |
| PRIMARY | Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Phase 1: Up to Cycle 1 (3 weeks) | The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT. | participants | NUMBER |
| PRIMARY | Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | Safety population included all participants who received any amount of study drug. | participants | NUMBER |
| PRIMARY | Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | Safety population included all participants who received any amount of study drug. | participants | NUMBER |
| PRIMARY | Phase 1- Recommended Phase 2 Dose (RP2D) | Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks) | The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT. | mg/kg | NUMBER |
| PRIMARY | Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | The Pharmacokinetic (PK) evaluable population included all participants who received greater than or equal to (\>=1) dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | The PK evaluable population included all participants who received \>=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. | mcg/mL | GEOMETRIC_MEAN |
| PRIMARY | Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose | The PK evaluable population included all participants who received \>=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure. | day | MEDIAN |
| PRIMARY | Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264 | Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose | The PK evaluable population included all participants who received \>=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. | day | MEDIAN |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Phase 1: All Participants | 10 | participants | ||
| Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE) | Phase 1: All Participants | 4 | participants | ||
| Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Phase 1: All Participants | 0 | participants | ||
| Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: All Participants | Serum Chemistry | 10 | participants | |
| Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: All Participants | Hematology | 12 | participants | |
| Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: All Participants | Urinalysis | 1 | participants | |
| Phase 1- Number of Participants With Markedly Abnormal Laboratory Values | Phase 1: All Participants | Coagulation | 5 | participants | |
| Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Phase 1: All Participants | 0 | participants | ||
| Phase 1- Recommended Phase 2 Dose (RP2D) | Phase 1: All Participants | NA | mg/kg | ||
| Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264 | Phase 1: MLN0264 1.2 mg/kg | 25.62 | Standard Deviation 0.907 | microgram per milliliter (mcg/mL) |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: MLN0264 1.2 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1: MLN0264 1.5 mg/kg | 3 | |
| Overall Study | STARTED | Phase 1: MLN0264 1.8 mg/kg | 6 | |
| Overall Study | COMPLETED | Phase 1: MLN0264 1.2 mg/kg | 0 | |
| Overall Study | COMPLETED | Phase 1: MLN0264 1.5 mg/kg | 0 | |
| Overall Study | COMPLETED | Phase 1: MLN0264 1.8 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Phase 1: MLN0264 1.2 mg/kg | 3 | |
| Overall Study | NOT COMPLETED | Phase 1: MLN0264 1.5 mg/kg | 3 | |
| Overall Study | NOT COMPLETED | Phase 1: MLN0264 1.8 mg/kg | 6 |
Source ClinicalTrials.gov
Adverse events45
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 | Anaemia | Blood and lymphatic system disorders | Phase 1: All Participants | 1 | 12 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1: All Participants | 1 | 12 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: All Participants | 1 | 12 | |
| other | Eye discharge | Eye disorders | Phase 1: All Participants | 1 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Phase 1: All Participants | 2 | 12 | |
| other | Ascites | Gastrointestinal disorders | Phase 1: All Participants | 1 | 12 | |
| other | Constipation | Gastrointestinal disorders | Phase 1: All Participants | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Phase 1: All Participants | 2 | 12 | |
| other | Dyspepsia | Gastrointestinal disorders | Phase 1: All Participants | 1 | 12 | |
| other | Haematochezia | Gastrointestinal disorders | Phase 1: All Participants | 1 | 12 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: All Participants | ||
| Total, other adverse events | Phase 1: All Participants | 10 | 12 |
| Total, serious adverse events | Phase 1: All Participants | 4 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02391038
GET https://conductscience.org/api/trials/v1/NCT02391038/registered?page=2