Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Sponsor
Exelixis (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03170960
Collaborator
(none)
1,732
124
25
62.9
14
0.2

Study Details

Study Description

Brief 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.

Detailed Description

  • Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks).

  • Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR] per RECIST 1.1) and safety of the recommended combination dose of cabozantinib with atezolizumab in eighteen tumor-specific cohorts including subjects with advanced UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N, and DTC.

  • Exploratory SAC Cohorts: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent cabozantinib in UC, NSCLC, and CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy

  • Exploratory SAA Cohort: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent atezolizumab in CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1732 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Dose Escalation followed by Dose ExpansionDose Escalation followed by Dose Expansion
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date :
Sep 5, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose Escalation

Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.

Drug: cabozantinib
Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
Other Names:
  • Cabometyx
  • XL184
  • Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Experimental: Expansion Cohort 1

    RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 2

    UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 3

    UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 4

    UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 5

    UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 6

    CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 7

    Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 8

    Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 9

    Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 10

    RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 11

    TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 12

    OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 13

    EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 14

    HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 15

    GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 16

    CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 17

    H&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 18

    DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 19 (SAC)

    UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

    Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 20 (SAC)

    Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

    Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 21 (SAC)

    Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

    Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 22 (SAA)

    Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Experimental: Expansion Cohort 23

    Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Experimental: Expansion Cohort 24

    Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with at least one NHT and have received docetaxel for mCRPC

    Drug: atezolizumab
    Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
    Other Names:
  • Tecentriq
  • Drug: cabozantinib
    Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
    Other Names:
  • Cabometyx
  • XL184
  • Outcome Measures

    Primary Outcome Measures

    1. Dose Escalation: MTD/Recommended Dose [Up to 6 months]

      To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with solid tumors when taken in combination with atezolizumab.

    2. Dose Expansion: ORR [Up to 31 months]

      To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.

    Secondary Outcome Measures

    1. Incidence and severity of nonserious AEs and SAEs (Safety) [Up to 41 months]

      To assess safety for the combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs), including immune-related adverse events (irAEs).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
    • Dose-Escalation Stage:

    • Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or

    • Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy

    • Expansion Stage:

    • Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H&N cancer, and DTC as outlined above)

    1. Measurable disease per RECIST 1.1 as determined by the investigator.

    2. Tumor tissue material available (archival or recent tumor biopsy)

    3. Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.

    4. Age eighteen years or older on the day of consent.

    5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

    6. Adequate organ and marrow function.

    7. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.

    8. Female subjects of childbearing potential must not be pregnant at screening.

    Exclusion Criteria:
    1. Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.

    2. Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.

    3. Concomitant anticoagulation with oral anticoagulants.

    4. Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.

    5. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.

    6. The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).

    7. Pregnant or lactating females.

    8. Previously identified allergy or hypersensitivity to components of the study treatment formulations.

    9. Diagnosis of another malignancy within 2 years before first dose of study treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Exelixis Clinical Site #53 Gilbert Arizona United States 85234
    2 Exelixis Clinical Site #18 Phoenix Arizona United States 85054
    3 Exelixis Clinical Site #1 Duarte California United States 91010
    4 Exelixis Clinical Site #20 La Jolla California United States 92090
    5 Exelixis Clinical Site #46 Los Angeles California United States 90025
    6 Exelixis Clinical Site #51 Newport Beach California United States 92663
    7 Exelixis Clinical Site #62 Santa Monica California United States 90404
    8 Exelixis Clinical Site #21 Stanford California United States 94305
    9 Exelixis Clinical Site #34 Denver Colorado United States 80218
    10 Exelixis Clinical Site #50 Denver Colorado United States 80218
    11 Exelixis Clinical Site #42 New Haven Connecticut United States 06511
    12 Exelixis Clinical Site #48 Washington District of Columbia United States 20007
    13 Exelixis Clinical Site #16 Jacksonville Florida United States 32224
    14 Exelixis Clinical Site #76 Tampa Florida United States 33612
    15 Exelixis Clinical Site #60 Atlanta Georgia United States 30318
    16 Exelixis Clinical Site #79 Atlanta Georgia United States 30341
    17 Exelixis Clinical Site #32 Harvey Illinois United States 60426
    18 Exelixis Clinical Site #23 Fairway Kansas United States 66205
    19 Exelixis Clinical Site #57 Lexington Kentucky United States 40536
    20 Exelixis Clinical Site #24 New Orleans Louisiana United States 70112
    21 Exelixis Clinical Site #10 Boston Massachusetts United States 02215
    22 Exelixis Clinical Site #3 Detroit Michigan United States 48201
    23 Exelixis Clinical Site #17 Rochester Minnesota United States 55905
    24 Exelixis Clinical Site #65 Bolivar Missouri United States 65613
    25 Exelixis Clinical Site #43 Kansas City Missouri United States 64111
    26 Exelixis Clinical Site #35 Omaha Nebraska United States 68130
    27 Exelixis Clinical Site #59 Omaha Nebraska United States 68130
    28 Exelixis Clinical Site #61 Las Vegas Nevada United States 89169
    29 Exelixis Clinical Site #38 Camden New Jersey United States 08103
    30 Exelixis Clinical Site #27 East Brunswick New Jersey United States 08816
    31 Exelixis Clinical Site #31 New Brunswick New Jersey United States 08903
    32 Exelixis Clinical Site #37 Bronx New York United States 10461
    33 Exelixis Clinical Site #40 East Setauket New York United States 11733
    34 Exelixis Clinical Site #11 New York New York United States 10029
    35 Exelixis Clinical Site #67 Cleveland Ohio United States 44195
    36 Exelixis Clinical Site #49 Columbus Ohio United States 43210
    37 Exelixis Clinical Site #64 Kettering Ohio United States 45409
    38 Exelixis Clinical Site #71 Oklahoma City Oklahoma United States 73104
    39 Exelixis Clinical Site #6 Oklahoma City Oklahoma United States 73120
    40 Exelixis Clinical Site #102 Portland Oregon United States 97213
    41 Exelixis Clinical Site #45 Portland Oregon United States 97239
    42 Exelixis Clinical Site #41 Bethlehem Pennsylvania United States 18015
    43 Exelixis Clinical Site #15 Philadelphia Pennsylvania United States 19107
    44 Exelixis Clinical Site #55 Philadelphia Pennsylvania United States 19111
    45 Exelixis Clinical Site #66 Pittsburgh Pennsylvania United States 15232
    46 Exelixis Clinical Site #95 Charleston South Carolina United States 29414
    47 Exelixis Clinical Site #13 Dallas Texas United States 75246
    48 Exelixis Clinical Site #26 Dallas Texas United States 75390
    49 Exelixis Clinical Site #114 Fort Worth Texas United States 76104
    50 Exelixis Clinical Site #29 Houston Texas United States 77030
    51 Exelixis Clinical Site #39 Houston Texas United States 77030
    52 Exelixis Clinical Site #44 Houston Texas United States 77030
    53 Exelixis Clinical Site #33 Lubbock Texas United States 79410
    54 Exelixis Clinical Site #63 San Antonio Texas United States 78229
    55 Exelixis Clinical Site #2 Salt Lake City Utah United States 84112
    56 Exelixis Clinical Site #30 Blacksburg Virginia United States 24060
    57 Exelixis Clinical Site #14 Charlottesville Virginia United States 22908
    58 Exelixis Clinical Site #98 Albury New South Wales Australia 2640
    59 Exelixis Clinical Site #101 Camperdown New South Wales Australia 2050
    60 Exelixis Clinical Site #115 Gosford New South Wales Australia 2250
    61 Exelixis Clinical Site #112 North Ryde New South Wales Australia 2109
    62 Exelixis Clinical Site #123 Randwick New South Wales Australia 2031
    63 Exelixis Clinical Site #99 St Albans Victoria Australia 3021
    64 Exelixis Clinical Site #52 Gent Belgium 9000
    65 Exelixis Clinical Site #54 Leuven Belgium 3000
    66 Exelixis Clinical Site #88 La Roche-sur-Yon Cedex 9 France 85925
    67 Exelixis Clinical Site #8 Villejuif Cedex France 94805
    68 Exelixis Clinical Site #92 Bordeaux France 33076
    69 Exelixis Clinical Site #93 Brest France 29229
    70 Exelixis Clinical Site #87 CAEN Cedex 05 France 14076
    71 Exelixis Clinical Site #69 Le Mans France 72000
    72 Exelixis Clinical Site #97 Lille France 59000
    73 Exelixis Clinical Site #89 Lyon Cedex 08 France 69373
    74 Exelixis Clinical Site #109 Marseille France 13273
    75 Exelixis Clinical Site #104 Nice Cedex 02 France 06189
    76 Exelixis Clinical Site #80 Nîmes Cedex 09 France 30029
    77 Exelixis Clinical Site #78 Paris France 75005
    78 Exelixis Clinical Site #7 Paris France 75010
    79 Exelixis Clinical Site #68 Paris France 75013
    80 Exelixis Clinical Site #72 Paris France 75015
    81 Exelixis Clinical Site #82 Saint-Grégoire France 35760
    82 Exelixis Clinical Site #119 Strasbourg France 67000
    83 Exelixis Clinical Site #107 Suresnes France 92150
    84 Exelixis Clinical Site #105 Vandoeuvre les nancy France 54519
    85 Exelixis Clinical Site #56 Düsseldorf Nordrhein-Westfalen Germany 40225
    86 Exelixis Clinical Site #36 Tübingen Germany 72076
    87 Exelixis Clinical Site #84 Meldola FC Italy 47014
    88 Exelixis Clinical Site #47 Rozzano Milano Italy 20089
    89 Exelixis Clinical Site #108 Milano Italy 20132
    90 Exelixis Clinical Site #103 Milano Italy 20133
    91 Exelixis Clinical Site #25 Milano Italy 20133
    92 Exelixis Clinical Site #4 Milano Italy 20133
    93 Exelixis Clinical Site #85 Napoli Italy 80131
    94 Exelixis Clinical Site #121 Pavia Italy 27100
    95 Exelixis Clinical Site #110 Roma Italy 00168
    96 Exelixis Clinical Site #12 Nijmegen Gelderland Netherlands 6525 GA
    97 Exelixis Clinical Site #74 Santiago De Compostela A Coruña Spain 15706
    98 Exelixis Clinical Site #91 Elche Alicante Spain 03203
    99 Exelixis Clinical Site #94 Oviedo Asturias Spain 33011
    100 Exelixis Clinical Site #70 Palma De Mallorca Baleares Spain 07120 / 07010
    101 Exelixis Clinical Site #113 Badalona Barcelona Spain 08916
    102 Exelixis Clinical Site #116 Sabadell Barcelona Spain 08208
    103 Exelixis Clinical Site #96 Jeréz De La Frontera Cádiz Spain 11407
    104 Exelixis Clinical Site #90 Pamplona Navarra Spain 31008
    105 Exelixis Clinical Site #117 La Laguna Santa Cruz De Tenerife Spain 38320
    106 Exelixis Clinical Site #75 Barcelona Spain 08003
    107 Exelixis Clinical Site #58 Barcelona Spain 08022
    108 Exelixis Clinical Site #83 Barcelona Spain 08023
    109 Exelixis Clinical Site #86 Barcelona Spain 08025
    110 Exelixis Clinical Site #28 Barcelona Spain 08035
    111 Exelixis Clinical Site #9 Barcelona Spain 08035
    112 Exelixis Clinical Site #73 Barcelona Spain 08036
    113 Exelixis Clinical Site #118 Girona Spain 17007
    114 Exelixis Clinical Site #77 Madrid Spain 28034
    115 Exelixis Clinical Site #106 Madrid Spain 28040
    116 Exelixis Clinical Site #111 Madrid Spain 28040
    117 Exelixis Clinical Site #22 Madrid Spain 28041
    118 Exelixis Clinical Site #5 Madrid Spain 28041
    119 Exelixis Clinical Site #81 Madrid Spain 28046
    120 Exelixis Clinical Site #100 Málaga Spain 29010
    121 Exelixis Clinical Site #122 Middlesex England United Kingdom HA6 2RN
    122 Exelixis Clinical Site #120 Preston England United Kingdom PR2 9HT
    123 Exelixis Clinical Site #124 Cardiff Wales United Kingdom CF14 2TL
    124 Exelixis Clinical Site #19 London United Kingdom EC1M 6BQ

    Sponsors and Collaborators

    • Exelixis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exelixis
    ClinicalTrials.gov Identifier:
    NCT03170960
    Other Study ID Numbers:
    • XL184-021
    First Posted:
    May 31, 2017
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Exelixis
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 12, 2022