Trial · NCT01631552
Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
NCT01631552, Phase 1, Phase 2, Completed, Gilead Sciences; results first posted 2021-04-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer. Trials, record NCT01631552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01631552
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer
- NCT number
- NCT01631552
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 515 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
Gastric Adenocarcinoma, Esophageal Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Small Cell Lung Cancer, Ovarian Epithelial Cancer, Carcinoma Breast Stage IV, Hormone-refractory Prostate Cancer, Head and Neck Cancers- Squamous Cell, Renal Cell Cancer, Urinary Bladder Neoplasms, Cervical Cancer, Endometrial Cancer, Glioblastoma Multiforme, Triple Negative Breast Cancer, Pancreatic Cancer
- Interventions
- Sacituzumab Govitecan-hziy (SG)
- First posted
- 2012-06-29
- Last updated
- 2021-08-12
- Results first posted
- 2021-04-06
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days | Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious: * Fatal * Life-threatening * Disabling/incapacitating * Results in hospitalization or prolongs a hospital stay * A congenital abnormality * Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population. |
| Primary | Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) | Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP). |
| Primary | Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) | Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP). |
| Primary | Objective Response Rate (ORR) by Independent Central Review (ICR) | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only. |
| Primary | Objective Response Rate by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population. |
| Secondary | Duration of Response by ICR | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only. |
| Secondary | Duration of Response by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Duration of Response was defined as the duration of overall response measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Per planned analysis, duration of response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population. |
| Secondary | Time to Response by ICR | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by ICR was assessed for the TNBC Target Population only. |
| Secondary | Time to Response by Local Assessments | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Time to response was defined as the time from the first dose to the first documentation of response (PR or CR). Per planned analysis, time to response by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population. |
| Secondary | Clinical Benefit Rate (CBR) by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Clinical benefit rate (CR+PR+\[stable disease (SD) ≥ 6 months\]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier. Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population. |
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 | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG~* OSP: All participants who received at least 1 dose of SG | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG~* OSP: All participants who received at least 1 dose of SG | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events | First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG~* OSP: All participants who received at least 1 dose of SG | Percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate (ORR) by Independent Central Review (ICR) | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. | Percentage of participants | NUMBER |
| PRIMARY | Objective Response Rate by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response by ICR | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease and who received SG at a dose of 10 mg/kg. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only. | months | MEDIAN |
| SECONDARY | Duration of Response by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG | months | MEDIAN |
| SECONDARY | Time to Response by ICR | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG | months | MEDIAN |
| SECONDARY | Time to Response by Local Assessments | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) by Local Assessment | Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG~* HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG~* mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | TNBC Target Population | Adverse Events | 100.0 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | HR+/HER2- mBC Population | Adverse Events | 100.0 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | mUC Population | Adverse Events | 100.0 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | Overall Safety Population (OSP) | Adverse Events | 99.8 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | TNBC Target Population | Serious Adverse Events | 30.6 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | HR+/HER2- mBC Population | Serious Adverse Events | 35.2 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | mUC Population | Serious Adverse Events | 42.2 | Percentage of participants | |
| Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events | Overall Safety Population (OSP) | Serious Adverse Events | 38.8 | Percentage of participants | |
| Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | TNBC Target Population | 2.8 | Percentage of participants | ||
| Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death | HR+/HER2- mBC Population | 5.6 | Percentage of participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sacituzumab Govitecan-hziy (SG) 8 mg/kg | 83 | |
| Overall Study | STARTED | SG 10 mg/kg | 420 | |
| Overall Study | STARTED | SG 12 mg/kg | 9 | |
| Overall Study | STARTED | SG 18 mg/kg | 3 | |
| Overall Study | Enrolled and Treated | Sacituzumab Govitecan-hziy (SG) 8 mg/kg | 81 | |
| Overall Study | Enrolled and Treated | SG 10 mg/kg | 402 | |
| Overall Study | Enrolled and Treated | SG 12 mg/kg | 9 | |
| Overall Study | Enrolled and Treated | SG 18 mg/kg | 3 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan-hziy (SG) 8 mg/kg | 81 | |
| Overall Study | COMPLETED | SG 10 mg/kg | 400 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events193
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 | Overall Safety Population | 207 | 495 | |
| other | Neutropenia | Blood and lymphatic system disorders | Overall Safety Population | 196 | 495 | |
| other | Abdominal distension | Gastrointestinal disorders | Overall Safety Population | 25 | 495 | |
| other | Abdominal pain | Gastrointestinal disorders | Overall Safety Population | 108 | 495 | |
| other | Constipation | Gastrointestinal disorders | Overall Safety Population | 184 | 495 | |
| other | Diarrhoea | Gastrointestinal disorders | Overall Safety Population | 303 | 495 | |
| other | Dyspepsia | Gastrointestinal disorders | Overall Safety Population | 26 | 495 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Overall Safety Population | 25 | 495 | |
| other | Nausea | Gastrointestinal disorders | Overall Safety Population | 342 | 495 | |
| other | Stomatitis | Gastrointestinal disorders | Overall Safety Population | 27 | 495 |
1 to 10 of 193Source ClinicalTrials.gov
See all 193 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Safety Population | 422 | 495 |
| Total, other adverse events | Overall Safety Population | 490 | 495 |
| Total, serious adverse events | Overall Safety Population | 192 | 495 |
Source ClinicalTrials.gov
Papers14
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/NCT01631552
GET https://conductscience.org/api/trials/v1/NCT01631552/results?page=2