Trial ยท NCT01772004
Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
NCT01772004, Phase 1, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2021-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor). Trials, record NCT01772004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01772004
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
- NCT number
- NCT01772004
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 1,756 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Solid Tumors
- Interventions
- Avelumab
- First posted
- 2013-01-21
- Last updated
- 2021-12-20
- Other registries' IDs
- eudract:2013-002834-19
- Results first posted
- 2021-12-20
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation: Baseline up to Week 3 | DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any one of following: any Grade (Gr) \>=3toxicity that is possibly/probably/ definitely related to avelumab, except for any of following: Gr 3 infusion-related reaction resolving within 6 hours and controlled with medical management, Transient Gr 3 flu-like symptoms/fever, which is controlled with medical management, Transient Gr 3 fatigue, local reactions, headache, nausea, emesis that resolves to \<= Gr 1, Gr3 diarrhea, Gr 3 skin toxicity, Gr 3 liver function test increase that resolves to \<= Gr1 in \< 7 days after medical management has been initiated, Single laboratory values out of normal range that were unlikely related to study treatment according to investigator, did not have any clinical correlate, and resolved to \<= Gr1 within 7 days with adequate medical management and tumor flare phenomenon defined as local pain, irritation/rash localized at sites of known/suspected tumor. |
| Primary | Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Ovarian Cancer Efficacy Expansion: Baseline up to Day 620 | Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. |
| Primary | Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931 | Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions. |
| Primary | Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871 | Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1 or more new lesions and unequivocal progression of non-target lesions. |
| Primary | Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | HNSCC Efficacy Expansion: Baseline up to Day 1072 | Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an Independent Endpoint Review Committee (IERC) and defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30%reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. |
| Secondary | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity | Up to Day 2511 | Adverse event(AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of study drug, whether or not related to study drug. A serious adverse event(SAE) was an AE that resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent events were events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration.TEAEs included both Serious TEAEs and non-serious TEAEs. Severity of TEAEs were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death. |
| Secondary | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity | Baseline up to Day 2511 | AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. Treatment-emergent events were the events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a "Possible" or "Related" relationship to study treatment, as assessed by the Investigator. Severity of Treatment-Related TEAEs were graded using NCI-CTCAE version 4.0 toxicity grades, as follows: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death. |
| Secondary | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Area under the serum concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule. |
| Secondary | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. |
| Secondary | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Cmax is the maximum observed serum concentration obtained directly from the concentration versus time curve. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation: Baseline up to Week 3 | DLT analysis set included all participants with data used for implementing the dose-escalation schedule. These participants should have received all study drug administrations in the DLT evaluation period, or should have stopped treatment because of DLTs in the DLT evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Ovarian Cancer Efficacy Expansion: Baseline up to Day 620 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort(Urothelial Carcinoma): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Urothelial Carcinoma Efficacy Expansion: Baseline up to Day 931 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (GC/GEJC, Third Line): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | GC/GEJC, Third Line Efficacy Expansion: Baseline up to Day 871 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy Expansion Cohort (HNSCC): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | HNSCC Efficacy Expansion: Baseline up to Day 1072 | Full analysis set (FAS) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs as Per Severity | Up to Day 2511 | Safety analysis set (SAF) included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation and Expansion Cohorts: Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs as Per Severity | Baseline up to Day 2511 | SAF included all participants who have received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under Serum Concentration-Time Curve From the Time of Dosing to the Time of the Last Observation (AUC0-t) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. | Hours*micrograms per milliliter | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. Here Overall number of participants analyzed signifies those who were evaluable for this outcome measure. | Hours*micrograms per milliliter | MEAN |
| SECONDARY | Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Maximum Observed Serum Concentration (Cmax) of Avelumab | Pre-infusion, at end of 1-hour infusion (Day 1), 0.5, 1, 2, 4, 6,12, 24, 36, 48 hours after end of infusion | Pharmacokinetic (PK) population included all participants who have completed at least 1 infusion of study drug, and who have provided sufficient concentration measurements. | Micrograms per milliliter (mcg/mL) | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group993
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation Cohort: Avelumab 1.0 mg/kg | 0 | Participants | ||
| Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation Cohort: Avelumab 3.0 mg/kg | 0 | Participants | ||
| Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation Cohort: Avelumab 10.0 mg/kg | 0 | Participants | ||
| Dose Escalation Cohort (Excluding Once Weekly Avelumab 10 mg/kg Cohort): Number of Participants Experiencing Dose Limiting Toxicities (DLTs) | Dose Escalation Cohort: Avelumab 20.0 mg/kg | 1 | Participants | ||
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Complete response (CR) | 3 | Participants | |
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Partial response (PR) | 1 | Participants | |
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Stable disease (SD) | 41 | Participants | |
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Progressive disease (PD) | 39 | Participants | |
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Non-CR/Non-PD | 3 | Participants | |
Efficacy Expansion Cohort (Ovarian Cancer): Number of Participants With Confirmed Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), as Adjudicated by Independent Endpoint Review Committee (IERC) | Efficacy Expansion Cohort: Ovarian Cancer | Non-evaluable | 16 | Participants |
1 to 10 of 993Source ClinicalTrials.gov
See all 993 results by groupParticipant flow138
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Phase | STARTED | Dose Escalation Cohort: Avelumab 1.0 mg/kg | 4 | |
| Dose Escalation Phase | STARTED | Dose Escalation Cohort: Avelumab 3.0 mg/kg | 13 | |
| Dose Escalation Phase | STARTED | Dose Escalation Cohort: Avelumab 10.0 mg/kg | 15 | |
| Dose Escalation Phase | STARTED | Dose Escalation Cohort: Avelumab 20.0 mg/kg | 21 | |
| Dose Escalation Phase | STARTED | Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 8 | |
| Dose Escalation Phase | STARTED | Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 0 | |
| Dose Escalation Phase | STARTED | Primary Expansion Cohort: NSCLC, First Line | 0 | |
| Dose Escalation Phase | STARTED | Primary Expansion Cohort: Metastatic Breast Cancer | 0 | |
| Dose Escalation Phase | STARTED | Primary Expansion Cohort: GC/GEJC Progressed | 0 | |
| Dose Escalation Phase | STARTED | Primary Expansion Cohort: GC/GEJC Non Progressed | 0 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 participant flowAdverse events40,618
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 | Fatigue | General disorders | Dose Escalation Cohort: Avelumab 1.0 mg/kg | 2 | 4 | |
| other | Fatigue | General disorders | Dose Escalation Cohort: Avelumab 3.0 mg/kg | 7 | 13 | |
| other | Fatigue | General disorders | Dose Escalation Cohort: Avelumab 10.0 mg/kg | 13 | 15 | |
| other | Fatigue | General disorders | Dose Escalation Cohort: Avelumab 20.0 mg/kg | 6 | 21 | |
| other | Fatigue | General disorders | Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 3 | 8 | |
| other | Fatigue | General disorders | Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 74 | 184 | |
| other | Fatigue | General disorders | Primary Expansion Cohort: NSCLC, First Line | 71 | 156 | |
| other | Fatigue | General disorders | Primary Expansion Cohort: Metastatic Breast Cancer | 66 | 168 | |
| other | Fatigue | General disorders | Primary Expansion Cohort: GC/GEJC Progressed | 13 | 60 | |
| other | Fatigue | General disorders | Primary Expansion Cohort: GC/GEJC Non Progressed | 20 | 90 |
1 to 10 of 40,618Source ClinicalTrials.gov
See all 40,618 adverse eventsAdverse event totals69
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Cohort: Avelumab 1.0 mg/kg | 4 | 4 |
| Total, all-cause mortality | Dose Escalation Cohort: Avelumab 3.0 mg/kg | 11 | 13 |
| Total, all-cause mortality | Dose Escalation Cohort: Avelumab 10.0 mg/kg | 11 | 15 |
| Total, all-cause mortality | Dose Escalation Cohort: Avelumab 20.0 mg/kg | 16 | 21 |
| Total, all-cause mortality | Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly | 2 | 8 |
| Total, all-cause mortality | Primary Expansion Cohort: NSCLC, Post-platinum Doublet | 161 | 184 |
| Total, all-cause mortality | Primary Expansion Cohort: NSCLC, First Line | 124 | 156 |
| Total, all-cause mortality | Primary Expansion Cohort: Metastatic Breast Cancer | 141 | 168 |
| Total, all-cause mortality | Primary Expansion Cohort: GC/GEJC Progressed | 50 | 60 |
| Total, all-cause mortality | Primary Expansion Cohort: GC/GEJC Non Progressed | 75 | 90 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse event totalsPapers19
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/NCT01772004
GET https://conductscience.org/api/trials/v1/NCT01772004/registered?page=2