Trials / Completed
CompletedNCT03798626
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 167 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gevokizumab | 60 mg/mL concentration; administered intravenously (IV) |
| DRUG | Bevacizumab | 25 mg/mL concentration; administered IV |
| DRUG | Modified FOLFOX6 | Oxaliplatin \[5 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\] |
| DRUG | FOLFIRI | Irinotecan \[20 mg/mL concentration; administered IV\], leucovorin \[10 mg/mL concentration; administered IV\] (or levoleucovorin \[10 mg/mL concentration; administered IV\]), and 5-fluorouracil \[50 mg/mL concentration; administered IV\] |
| DRUG | Ramucirumab | 10 mg/mL concentration; administered IV |
| DRUG | Paclitaxel | 6 mg/mL concentration; administered IV |
| DRUG | Cabozantinib | 60 mg tablet; administered orally |
Timeline
- Start date
- 2019-05-22
- Primary completion
- 2023-03-01
- Completion
- 2025-02-05
- First posted
- 2019-01-10
- Last updated
- 2026-04-01
Locations
34 sites across 15 countries: United States, Australia, Belgium, Canada, Chile, Czechia, Germany, Israel, Italy, Japan, Singapore, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03798626. Inclusion in this directory is not an endorsement.