Trial · NCT01803282
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
NCT01803282, Phase 1, Completed, Gilead Sciences; results first posted 2020-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors. Trials, record NCT01803282. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01803282
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
- NCT number
- NCT01803282
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 236 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pancreatic Cancer, Non-small Cell Lung Cancer, Esophagogastric Cancer, Colorectal Cancer, Breast Cancer
- Interventions
- Andecaliximab, Gemcitabine, Nab-paclitaxel, Carboplatin, Pemetrexed, Leucovorin, Oxaliplatin, 5-FU, Bevacizumab, Irinotecan, Paclitaxel
- First posted
- 2013-03-04
- Last updated
- 2020-06-02
- Results first posted
- 2020-05-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | |
| Primary | Percentage of Participants Experiencing Laboratory Abnormalities | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported. |
Source ClinicalTrials.gov
Outcomes2
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 Treatment-Emergent Adverse Events | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | The Safety Analysis Set included all participants who received at least 1 infusion at any dose level of study drug (ADX). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Laboratory Abnormalities | Part A: First dose date up to 32 weeks plus 30 days; Part B: First dose date up to 181 weeks plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
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 Treatment-Emergent Adverse Events | Part A: ADX 200 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part A: ADX 600 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part A: ADX 1800 mg | 83.3 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: PAC, ADX 800 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: LAC, ADX 1200 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: LSC, ADX 1200 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: EGC, ADX 800 mg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 100.0 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: ADX 200 mg | 4 | |
| Overall Study | STARTED | Part A: ADX 600 mg | 3 | |
| Overall Study | STARTED | Part A: ADX 1800 mg | 6 | |
| Overall Study | STARTED | Part B: PAC, ADX 800 mg | 36 | |
| Overall Study | STARTED | Part B: LAC, ADX 1200 mg | 11 | |
| Overall Study | STARTED | Part B: LSC, ADX 1200 mg | 10 | |
| Overall Study | STARTED | Part B: EGC, ADX 800 mg | 41 | |
| Overall Study | STARTED | Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 46 | |
| Overall Study | STARTED | Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 11 | |
| Overall Study | STARTED | Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 45 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events4,548
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 | Part A: ADX 200 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: ADX 600 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: ADX 1800 mg | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: PAC, ADX 800 mg | 11 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: LAC, ADX 1200 mg | 7 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: LSC, ADX 1200 mg | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: EGC, ADX 800 mg | 12 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 9 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 11 | 44 |
1 to 10 of 4,548Source ClinicalTrials.gov
See all 4,548 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: ADX 200 mg | 1 | 4 |
| Total, all-cause mortality | Part A: ADX 600 mg | 0 | 3 |
| Total, all-cause mortality | Part A: ADX 1800 mg | 1 | 6 |
| Total, all-cause mortality | Part B: PAC, ADX 800 mg | 8 | 36 |
| Total, all-cause mortality | Part B: LAC, ADX 1200 mg | 4 | 10 |
| Total, all-cause mortality | Part B: LSC, ADX 1200 mg | 3 | 10 |
| Total, all-cause mortality | Part B: EGC, ADX 800 mg | 13 | 40 |
| Total, all-cause mortality | Part B: FL CRC, ADX 800 mg+BEV 5 mg/kg | 22 | 45 |
| Total, all-cause mortality | Part B: FL CRC, ADX 800 mg+BEV 10 mg/kg | 5 | 11 |
| Total, all-cause mortality | Part B: SL CRC, ADX 800 mg+BEV 5 mg/kg | 25 | 44 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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/NCT01803282
GET https://conductscience.org/api/trials/v1/NCT01803282/results?page=2