18 and older, any sex, with Adenocarcinoma of the Stomach or Gastroesophageal Junction Expressing Guanylyl Cyclase C. 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.
Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)Primary· Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (up to 17 months)
ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
0
MLN0264 1.8 mg/kg (GCC Intermediate)
14
MLN0264 1.8 mg/kg (GCC High)
0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)Secondary· From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug wil
AEs
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
8
MLN0264 1.8 mg/kg (GCC Intermediate)
15
MLN0264 1.8 mg/kg (GCC High)
14
SAEs
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
2
MLN0264 1.8 mg/kg (GCC Intermediate)
5
MLN0264 1.8 mg/kg (GCC High)
0
Number of Participants With Potentially Clinically Significant Laboratory Evaluation FindingsSecondary· From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)
Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.
Chemistry
Group
Value
95% CI
MLN0264 1.8 mg/kg
8
Hematology
Group
Value
95% CI
MLN0264 1.8 mg/kg
13
Coagulation
Group
Value
95% CI
MLN0264 1.8 mg/kg
24
Urinalysis
Group
Value
95% CI
MLN0264 1.8 mg/kg
0
Number of Participants With Potentially Clinically Significant Vital Signs FindingsSecondary· Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 10.7 months)
Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Group
Value
95% CI
MLN0264 1.8 mg/kg
0
Progression Free Survival (PFS)Secondary· Time Frame: Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)
PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
40
38 – 311
MLN0264 1.8 mg/kg (GCC Intermediate)
49
38 – 316
MLN0264 1.8 mg/kg (GCC High)
87
39 – 427
Duration of ResponseSecondary· From first documented response until disease progression (Up to 16.7 months)
Duration of response is defined as the time in days from the date of first documentation of a confirmed response to the date of first documentation of disease progression. Per RECIST v1.1 for target lesions and assessed by magnetic resonance imaging (MRI) - CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Group
Value
95% CI
MLN0264 1.8 mg/kg
45.5
1 – 90
Disease Control RateSecondary· Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)
Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) of target lesions, taking as reference t
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
11
MLN0264 1.8 mg/kg (GCC Intermediate)
36
MLN0264 1.8 mg/kg (GCC High)
54
Overall Survival (OS)Secondary· Until death or 6 months after the last patient completes treatment-whichever occurs first (Up to 17 months)
Overall survival is defined as the time in days from the date of first study drug administration to the date of death.
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
230
79 – 394
MLN0264 1.8 mg/kg (GCC Intermediate)
156
49 – 505
MLN0264 1.8 mg/kg (GCC High)
206
24 – 427
MLN0264 Serum ConcentrationsSecondary· Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.
Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.
Cycle 1 Day 1, Pre-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.0000
± 0.00000
Cycle 1 Day 1, 10 Minutes Post-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
37.0434
± 9.93577
Cycle 1 Day 1, 4 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
26.0047
± 6.27538
Cycle 1 Day 3, 48 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
7.0839
± 1.64899
Cycle 1 Day 4, 72 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
4.4939
± 1.25657
Cycle 1 Day 8, 168 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
1.6795
± 0.71586
Cycle 1 Day 15, 336 Hours Post-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.5778
± 0.22063
Cycle 2 Day 1, Pre-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.7466
± 2.68737
Serum Concentration of Total Antibodies (Conjugated and Unconjugated)Secondary· Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.
Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.
Cycle 1 Day 1, Pre-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.0000
± 0.00000
Cycle 1 Day 1, 10 Minutes Post-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
41.8154
± 10.05341
Cycle 1 Day 1, 4 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
35.7626
± 8.46954
Cycle 1 Day 3, 48 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
16.0664
± 3.26969
Cycle 1 Day 4, 72 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
11.7461
± 2.60098
Cycle 1 Day 8, 168 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
6.1851
± 1.73972
Cycle 1 Day 15, 336 Hours Post-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
3.3926
± 1.00149
Cycle 2 Day 1, Pre-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
2.5995
± 3.79916
Serum Concentration of Monomethyl Auristatin E (MMAE)Secondary· Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.
Blood samples were collected and sent to a laboratory to be tested for MMAE.
Cycle 1 Day 1, Pre-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.000
± 0.0000
Cycle 1 Day 1, 10 Minutes Post-Dose (n=37)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.473
± 0.6503
Cycle 1 Day 1, 4 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
2.659
± 1.5489
Cycle 1 Day 3, 48 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
6.153
± 3.2773
Cycle 1 Day 4, 72 Hours Post-Dose (n=35)
Group
Value
95% CI
MLN0264 1.8 mg/kg
5.856
± 3.4519
Cycle 1 Day 8, 168 Hours Post-Dose (n=38)
Group
Value
95% CI
MLN0264 1.8 mg/kg
2.945
± 1.8899
Cycle 1 Day 15, 336 Hours Post-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.532
± 0.6693
Cycle 2 Day 1, Pre-Dose (n=36)
Group
Value
95% CI
MLN0264 1.8 mg/kg
0.116
± 0.1118
Number of Participants With Reduction From Baseline in Tumor SizeSecondary· Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)
The number of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.
Group
Value
95% CI
MLN0264 1.8 mg/kg (GCC Low)
1
38 – 311
MLN0264 1.8 mg/kg (GCC Intermediate)
2
38 – 316
MLN0264 1.8 mg/kg (GCC High)
4
42 – 427
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose through 30 days after the last dose of study drug (up to 10.7 Months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MLN0264 1.8 mg/kg
Serious: 7/38 (18%)
Deaths: —
Serious adverse events (9 terms)
Reaction
System
MLN0264 1.8 mg/kg
Diarrhoea
Gastrointestinal disorders
—
Dysphagia
Gastrointestinal disorders
—
Upper gastrointestinal hemorrhage
Gastrointestinal disorders
—
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Tumour hemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the stomach or gastroesophageal junction.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 15 May 2017
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/NCT02202759.