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NCT01803282 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 236
- Enrollment target
NCT01803282: Completed Phase 1 study, sponsored by Gilead Sciences.
NCT01803282 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 236 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (293% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01803282, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 236 participants
- Enrollment target
Study Summary
The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only qualify for and participate in 1 part. Part A is a sequential dose escalation to determine the maximum tolerated dose of andecaliximab in participants with advanced solid tumors that are refractory to or intolerant to standard therapy or for which no standard therapy exists. In Part A, participants will receive andecaliximab only. Part B is a dose expansion to obtain additional safety and tolerability data for andecaliximab in participants with advanced pancreatic adenocarcinoma, lung adenocarcinoma, lung squamous cell carcinoma, esophagogastric adenocarcinoma, colorectal cancer, or breast cancer. In Part B, participants will receive andecaliximab in combination with standard-of-care chemotherapy.
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Gemcitabine
- DRUG Nab-paclitaxel
- DRUG Andecaliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2013-03-29 |
| Est. Completion | 2019-04-23 |
| Phase | Phase 1 |
What the finished NCT01803282 record still lists
NCT01803282 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (293% higher).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01803282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01803282 about?
NCT01803282 is a clinical study titled "Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors". The primary objective of the study is to determine the maximum tolerated dose of andecaliximab monotherapy and to evaluate the safety and tolerability of andecaliximab (formerly GS-5745) alone and in combination with chemotherapy. The study consists of 2 parts (Parts A and B). Participants can only...
What is the current status of trial NCT01803282?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 236 participants. The study started on 2013-03-29. Estimated completion is 2019-04-23.
What interventions are being tested in trial NCT01803282?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Gemcitabine (DRUG), Nab-paclitaxel (DRUG), Andecaliximab (DRUG).
Who is sponsoring clinical trial NCT01803282?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01803282's enrollment target sits among peer trials
236 212th of 2000 higher than 1,789 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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