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NCT03170960 · ClinicalTrials.gov registry record · Phase 1
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, sponsored by Exelixis.
- Active
- Registry status
- Phase 1
- Development phase
- 914
- Enrollment target
- 20
- Study locations
NCT03170960 is a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 914 participants, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (39% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT03170960, a Phase 1 study of Non-Small Cell Lung Cancer and Ovarian Cancer, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 914 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H\&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.
Conditions Studied
Interventions
- DRUG cabozantinib
- DRUG atezolizumab
Study Locations (20)
California
- Exelixis Clinical Site #1 - Duarte
- Exelixis Clinical Site #20 - La Jolla
- Exelixis Clinical Site #46 - Los Angeles
- Exelixis Clinical Site #51 - Newport Beach
- Exelixis Clinical Site #62 - Santa Monica
- Exelixis Clinical Site #21 - Stanford
Arizona
- Exelixis Clinical Site #53 - Gilbert
- Exelixis Clinical Site #18 - Phoenix
Colorado
- Exelixis Clinical Site #34 - Denver
- Exelixis Clinical Site #50 - Denver
Florida
- Exelixis Clinical Site #16 - Jacksonville
- Exelixis Clinical Site #76 - Tampa
Georgia
- Exelixis Clinical Site #60 - Atlanta
- Exelixis Clinical Site #79 - Atlanta
Connecticut
- Exelixis Clinical Site #42 - New Haven
District of Columbia
- Exelixis Clinical Site #48 - Washington D.C.
Illinois
- Exelixis Clinical Site #32 - Harvey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 914 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03170960
The ClinicalTrials.gov registry entry for NCT03170960 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 914 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (39% higher). The listed sponsor is Exelixis, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which cabozantinib is the first listed.
NCT03170960 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03170960 about?
NCT03170960 is a clinical study titled "Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors". This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis...
What is the current status of trial NCT03170960?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 914 participants. The study started on 2017-09-05. Estimated completion is 2027-09-30.
What conditions does trial NCT03170960 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Hepatocellular Carcinoma.
What interventions are being tested in trial NCT03170960?
The interventions under investigation include: cabozantinib (DRUG), atezolizumab (DRUG).
Who is sponsoring clinical trial NCT03170960?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03170960 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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