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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 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 236 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01803282
The ClinicalTrials.gov registry entry for NCT01803282 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01803282 reports 0 study locations.
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.
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