A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Phase 3

Active, not recruiting

• Conditions: Differentiated Thyroid Cancer
• Interventions: Drug: Cabozantinib; Drug: Placebo

• Registration Number: NCT03690388
• Lead Sponsor: Exelixis

Brief Summary

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor (VEGFR)-Targeted therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-27
• Study First Posted: 2018-10-01
• Study Start: 2018-10-05
• Primary Completion: 2020-08-19
• Disposition First Submitted: 2021-05-05
• Results First Submitted: 2021-11-10
• Results First Submitted QC: 2023-05-16
• Results First Posted: 2023-05-18
• Disposition First Posted: 2023-05-18
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
2. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
3. Previously treated with or deemed ineligible for treatment with Iodine- 131 for differentiated thyroid cancer (DTC)
4. Previously treated with at least one of the following vascular endothelial growth factor receptor (VEGFR)-targeting tyrosine kinase inhibitor (TKI) agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

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Exclusion Criteria

1. Prior treatment with any of the following: Cabozantinib; Selective small-molecule v-raf murine sarcoma viral oncogene homolog B1 (BRAF) kinase inhibitor; More than 2 VEGFR-targeting TKI agents; More than 1 immune checkpoint inhibitor therapy; 1 systemic chemotherapy regimen (given as single agent or in combination with another chemotherapy agent)
2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks or 5 half-lives of the agent, whichever is longer, before randomization
3. Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
4. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization.
5. Known brain metastases or cranial epidural disease unless adequately treated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabozantinib	Cabozantinib	cabozantinib (60 mg) once daily orally (qd)
Placebo	Placebo	placebo once daily orally (qd)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.	Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
Objective Response Rate (ORR)	Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1.	Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).

Trial Locations

Locations (164)

Exelixis Clinical Site #2; 🇺🇸 Newport Beach, California, United States

Exelixis Clinical Site #153; 🇺🇸 Boston, Massachusetts, United States

Exelixis Clinical Site #75; 🇺🇸 Pittsburgh, Pennsylvania, United States

Exelixis Clinical Site #8; 🇺🇸 Houston, Texas, United States

Exelixis Clinical Site #54; 🇺🇸 Lexington, Kentucky, United States

Exelixis Clinical Site #113; 🇺🇸 Seattle, Washington, United States

Exelixis Clinical Site #94; 🇺🇸 Miami, Florida, United States

Exelixis Clinical Site #76; 🇺🇸 Charlotte, North Carolina, United States

Exelixis Clinical Site #17; 🇦🇺 St. Leonards, New South Wales, Australia

Exelixis Clinical Site #1; 🇺🇸 Philadelphia, Pennsylvania, United States

Exelixis Clinical Site #5; 🇺🇸 Bethlehem, Pennsylvania, United States

Exelixis Clinical Site #42; 🇺🇸 Saint Louis, Missouri, United States

Exelixis Clinical Site #63; 🇺🇸 Columbia, Missouri, United States

Exelixis Clinical Site #7; 🇺🇸 Cincinnati, Ohio, United States

Exelixis Clinical Site #86; 🇦🇺 Bedford Park, South Australia, Australia

Exelixis Clinical Site #18; 🇨🇦 Edmonton, Alberta, Canada

Exelixis Clinical Site #119; 🇦🇹 Vienna, Austria

Exelixis Clinical Site #27; 🇧🇪 Namur, Belgium

Exelixis Clinical Site #82; 🇫🇷 Nice, France

Exelixis Clinical Site #45; 🇫🇷 Angers, Pays De La Loire, France

Exelixis Clinical Site #129; 🇦🇷 Córdoba, Argentina

Exelixis Clinical Site #105; 🇨🇿 Brno, Czechia

Exelixis Clinical Site #35; 🇧🇷 Cascavel, Parana, Brazil

Exelixis Clinical Site #12; 🇦🇺 Herston, Australia

Exelixis Clinical Site #62; 🇦🇹 Salzburg, Austria

Exelixis Clinical Site #90; 🇧🇪 Anderlecht, Belgium

Exelixis Clinical Site #100; 🇧🇪 Gent, Belgium

Exelixis Clinical Site #135; 🇮🇹 Catania, CT, Italy

Exelixis Clinical Site #111; 🇮🇹 Siena, Italy

Exelixis Clinical Site #96; 🇦🇷 Pergamino, Buenos Aires, Argentina

Exelixis Clinical Site #97; 🇦🇷 Caba, Argentina

Exelixis Clinical Site #20; 🇨🇦 Calgary, Alberta, Canada

Exelixis Clinical Site #104; 🇨🇿 Olomouc, Czechia

Exelixis Clinical Site #107; 🇨🇦 London, Ontario, Canada

Exelixis Clinical Site #125; 🇩🇪 Marburg, Hesse, Germany

Exelixis Clinical Site #32; 🇫🇷 Dijon, Bourgogne-Franche-Comte, France

Exelixis Clinical Site #47; 🇧🇷 Sao Paulo, Brazil

Exelixis Clinical Site #116; 🇧🇷 Ribeirão Preto, São Paulo, Brazil

Exelixis Clinical Site #151; 🇩🇪 Dresden, Saxony, Germany

Exelixis Clinical Site #163; 🇩🇪 Hannover, Lower Saxony, Germany

Exelixis Clinical Site #128; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Exelixis Clinical Site #147; 🇲🇽 Ciudad de México, Mexico

Exelixis Clinical Site #148; 🇲🇽 Ciudad de México, Mexico

Exelixis Clinical Site #91; 🇫🇷 Lyon Cedex 08, France

Exelixis Clinical Site #44; 🇫🇷 Villejuif, Ile De France, France

Exelixis Clinical Site #34; 🇰🇷 Seoul, Korea, Republic of

Exelixis Clinical Site #102; 🇫🇷 Besançon, France

Exelixis Clinical Site #133; 🇲🇽 Ciudad de Mèxico, Mexico

Exelixis Clinical Site #15; 🇵🇱 Warszawa, Mazowieckie, Poland

Exelixis Clinical Site #61; 🇵🇱 Gliwice, Slaskie, Poland

Exelixis Clinical Site #146; 🇷🇴 Bucuresti, Romania

Exelixis Clinical Site #87; 🇮🇹 Roma, Italy

Exelixis Clinical Site #123; 🇮🇹 Padova, Italy

Exelixis Clinical Site #48; 🇷🇺 Obninsk, Kaluzhiskiy Region, Russian Federation

Exelixis Clinical Site #158; 🇲🇽 Tuxtla Gutiérrez, Chiapas, Mexico

Exelixis Clinical Site #136; 🇨🇳 Tainan, Taiwan

Exelixis Clinical Site #14; 🇪🇸 Barcelona, Spain

Exelixis Clinical Site #160; 🇩🇪 Freiburg, Germany

Exelixis Clinical Site #114; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #53; 🇷🇺 Moscow, Russian Federation

Exelixis Clinical Site #36; 🇰🇷 Seoul, Korea, Republic of

Exelixis Clinical Site #56; 🇮🇹 Napoli, Italy

Exelixis Clinical Site #70; 🇰🇷 Busan, Korea, Republic of

Exelixis Clinical Site #52; 🇷🇺 Samara, Russian Federation

Exelixis Clinical Site #89; 🇷🇺 Saint Petersburg, Russian Federation

Exelixis Clinical Site #142; 🇷🇴 Timişoara, Timis, Romania

Exelixis Clinical Site #149; 🇷🇴 Cluj-Napoca, Cluj, Romania

Exelixis Clinical Site #49; 🇷🇺 Moscow, Russian Federation

Exelixis Clinical Site #157; 🇷🇺 Tyumen, Tyumen Region, Russian Federation

Exelixis Clinical Site #101; 🇨🇳 Taipei, Taiwan

Exelixis Clinical Site #19; 🇺🇸 Durham, North Carolina, United States

Exelixis Clinical Site #126; 🇹🇭 Bangkok Noi, Bangkok, Thailand

Exelixis Clinical Site #39; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Exelixis Clinical Site #38; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Exelixis Clinical Site #122; 🇹🇭 Pathum Wan, Bangkok, Thailand

Exelixis Clinical Site #140; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Exelixis Clinical Site #69; 🇺🇸 San Francisco, California, United States

Exelixis Clinical Site #68; 🇺🇸 Nashville, Tennessee, United States

Exelixis Clinical Site #150; 🇷🇴 Craiova, Dolj, Romania

Exelixis Clinical Site #46; 🇭🇺 Budapest, Hungary

Exelixis Clinical Site #88; 🇬🇧 Birmingham, England, United Kingdom

Exelixis Clinical Site #51; 🇬🇧 Oxford, England, United Kingdom

Exelixis Clinical Site #59; 🇵🇱 Poznan, Wielkopolskie, Poland

Exelixis Clinical Site #112; 🇨🇳 Tainan, Taiwan

Exelixis Clinical Site #71; 🇬🇧 Bristol, England, United Kingdom

Exelixis Clinical Site #50; 🇬🇧 Glasgow, Scotland, United Kingdom

Exelixis Clinical Site #130; 🇹🇭 Hat Yai, Songkla, Thailand

Exelixis Clinical Site #64; 🇬🇧 Aberdeen, Scotland, United Kingdom

Exelixis Clinical Site #127; 🇮🇹 Roma, Italy

Exelixis Clinical Site #57; 🇬🇧 Sheffield, United Kingdom

Exelixis Clinical Site #67; 🇫🇷 Bordeaux, Nouvelle - Aquitaine, France

Exelixis Clinical Site #23; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #84; 🇷🇺 Moscow, Russian Federation

Exelixis Clinical Site #98; 🇺🇸 Sacramento, California, United States

Exelixis Clinical Site #6; 🇺🇸 Tampa, Florida, United States

Exelixis Clinical Site #80; 🇺🇸 Ann Arbor, Michigan, United States

Exelixis Clinical Site #78; 🇺🇸 Detroit, Michigan, United States

Exelixis Clinical Site #22; 🇺🇸 Detroit, Michigan, United States

Exelixis Clinical Site #11; 🇺🇸 Omaha, Nebraska, United States

Exelixis Clinical Site #4; 🇺🇸 Washington, District of Columbia, United States

Exelixis Clinical Site #43; 🇮🇱 Haifa, Israel

Exelixis Clinical Site #10; 🇺🇸 Stanford, California, United States

Exelixis Clinical Site #3; 🇺🇸 Torrance, California, United States

Exelixis Clinical Site #9; 🇺🇸 Aurora, Colorado, United States

Exelixis Clinical Site #164; 🇺🇸 Chicago, Illinois, United States

Exelixis Clinical Site #99; 🇪🇸 Barcelona, Spain

Exelixis Clinical Site #118; 🇺🇸 Morristown, New Jersey, United States

Exelixis Clinical Site #25; 🇦🇺 Waratah, New South Wales, Australia

Exelixis Clinical Site #26; 🇧🇪 Edegem, Belgium

Exelixis Clinical Site #24; 🇦🇺 Melbourne, Victoria, Australia

Exelixis Clinical Site #31; 🇧🇪 Brussels, Belgium

Exelixis Clinical Site #74; 🇧🇪 Edegem, Belgium

Exelixis Clinical Site #138; 🇭🇷 Zagreb, Croatia

Exelixis Clinical Site #40; 🇧🇷 Sao Jose do Rio Preto, Sao Paulo, Brazil

Exelixis Clinical Site #83; 🇨🇦 Toronto, Ontario, Canada

Exelixis Clinical Site #145; 🇭🇷 Osijek, Croatia

Exelixis Clinical Site #72; 🇫🇷 Marseille, Provence-Alpes-Cote d'Azur, France

Exelixis Clinical Site #92; 🇧🇷 Rio De Janeiro, Brazil

Exelixis Clinical Site #95; 🇫🇷 Strasbourg Cedex, France

Exelixis Clinical Site #152; 🇫🇷 Paris, France

Exelixis Clinical Site #121; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Exelixis Clinical Site #156; 🇩🇪 Würzburg, Bayern, Germany

Exelixis Clinical Site #124; 🇩🇪 Magdeburg, Sachsen-Anhalt, Germany

Exelixis Clinical Site #131; 🇩🇪 Bonn, Germany

Exelixis Clinical Site #155; 🇩🇪 Aachen, Germany

Exelixis Clinical Site #139; 🇩🇪 München, Germany

Exelixis Clinical Site #154; 🇩🇪 Essen, Germany

Exelixis Clinical Site #159; 🇩🇪 Hamburg, Germany

Exelixis Clinical Site #37; 🇭🇺 Pecs, Hungary

Exelixis Clinical Site #58; 🇮🇱 Petah tikva, Israel

Exelixis Clinical Site #109; 🇮🇹 Viagrande, Catania, Italy

Exelixis Clinical Site #41; 🇮🇱 Jerusalem, Israel

Exelixis Clinical Site #132; 🇮🇹 Meldola, Forlì - Cesena, Italy

Exelixis Clinical Site #144; 🇮🇹 Genova, GE, Italy

Exelixis Clinical Site #29; 🇮🇹 Pisa, PI, Italy

Exelixis Clinical Site #103; 🇮🇹 Milano, Italy

Exelixis Clinical Site #143; 🇮🇹 Rozzano, Milano, Italy

Exelixis Clinical Site #120; 🇮🇹 Torino, TO, Italy

Exelixis Clinical Site #108; 🇮🇹 Napoli, Italy

Exelixis Clinical Site #110; 🇮🇹 Milano, Italy

Exelixis Clinical Site #115; 🇮🇹 Milano, Italy

Exelixis Clinical Site #79; 🇰🇷 Gyeonggi-do, Korea, Republic of

Exelixis Clinical Site #161; 🇲🇽 San Luis Potosí, Mexico

Exelixis Clinical Site #117; 🇳🇱 Leiden, Zuid-Holland, Netherlands

Exelixis Clinical Site #55; 🇷🇺 Kislino, Kursk Region, Russian Federation

Exelixis Clinical Site #85; 🇷🇺 Moscow, Russian Federation

Exelixis Clinical Site #106; 🇷🇺 Omsk, Russian Federation

Exelixis Clinical Site #66; 🇷🇺 Yaroslavl, Russian Federation

Exelixis Clinical Site #16; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #30; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #33; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #73; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #13; 🇪🇸 Madrid, Spain

Exelixis Clinical Site #81; 🇪🇸 Málaga, Spain

Exelixis Clinical Site #77; 🇨🇳 Taipei, Taiwan

Exelixis Clinical Site #141; 🇹🇭 Ratchathewi, Bangkok, Thailand

Exelixis Clinical Site #162; 🇬🇧 London, England, United Kingdom

Exelixis Clinical Site #60; 🇬🇧 Cardiff, Wales, United Kingdom

Exelixis Clinical Site #65; 🇬🇧 Manchester, United Kingdom

Exelixis Clinical Site #137; 🇭🇷 Zagreb, Croatia

Exelixis Clinical Site #21; 🇺🇸 New Haven, Connecticut, United States

Exelixis Clinical Site #93; 🇺🇸 Orlando, Florida, United States

Exelixis Clinical Site #134; 🇺🇸 Charleston, South Carolina, United States

Exelixis Clinical Site #28; 🇭🇰 Hong Kong, Hong Kong