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Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT02862535
Collaborator
(none)
36
Enrollment
3
Locations
4
Arms
37.1
Actual Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to characterize the safety and tolerability of andecaliximab as monotherapy and in combination with anti-cancer agents in Japanese participants with inoperable advanced or recurrent gastric or recurrent gastroesophageal junction (GEJ) adenocarcinoma.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study to Evaluate the Safety and Tolerability of Andecaliximab (GS-5745) as Monotherapy and in Combination With Anti-Cancer Agents in Japanese Subjects With Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date :
Sep 20, 2016
Actual Primary Completion Date :
Oct 25, 2019
Actual Study Completion Date :
Oct 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: ADX

Participants will receive andecaliximab (ADX) 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

Drug: Andecaliximab
Administered via intravenous (IV) infusion (approximately 30 minutes)
Other Names:
  • GS-5745

    		•
    Experimental: Cohort 2: ADX + S-1 + Cisplatin

    Participants will receive ADX 800 mg every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with S-1 orally twice daily plus cisplatin chemotherapy (dosage and regimen will be based on participant condition, investigator discretion, institutional practice, and/or the in-country label) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

    Drug: Andecaliximab
    Administered via intravenous (IV) infusion (approximately 30 minutes)
    Other Names:
  • GS-5745

    • Drug: S-1
    Administered orally

    Drug: Cisplatin
    Administered via IV infusion on Day 8 of every 5 weeks
    Experimental: Cohort 3: ADX + S-1 + Oxaliplatin

    Participants will receive ADX 1200 mg every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin 100 mg/m^2) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study.

    Drug: Andecaliximab
    Administered via intravenous (IV) infusion (approximately 30 minutes)
    Other Names:
  • GS-5745

    • Drug: S-1
    Administered orally

    Drug: Oxaliplatin
    Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle
    Experimental: Cohort 4: ADX + Nivolumab

    Participants will receive ADX 800 mg every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.

    Drug: Andecaliximab
    Administered via intravenous (IV) infusion (approximately 30 minutes)
    Other Names:
  • GS-5745

    • Drug: Nivolumab
    Administered via IV infusion (approximately 60 minutes) every 2 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)]

      TEAEs are any AEs with an onset date of on or after the date that ADX and if applicable, nivolumab was first administered and no later than 30 days after permanent discontinuation of ADX, or if applicable, 5 months after permanent discontinuation of nivolumab (whichever is later).

    2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities [First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)]

      Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the specified time frame (first dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)) was considered treatment-emergent.Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used for assigning toxicity grades to laboratory results for analysis.

    Secondary Outcome Measures

    1. Cohort 1: Plasma Concentration of Andecaliximab [Pre-dose and 30 (±15) min after infusion on C2D1, C3D1, C5D1; EOS (3 years and 1 month); C1 only: 30 (±15) min after infusion on D1; anytime on D2, D4 and D8; Pre-dose and 30 (±15) minutes post infusion on D15]

      Plasma concentration is defined as the measured drug concentration. Blood samples were drawn at pre-dose and 30 (±15) minutes after infusion on Day 1 of Cycles 2, 3, 5; End of study (EOS) (3 years and 1 month); Cycle 1 only: 30 (±15) minutes after infusion on Day 1; anytime on Day 2, 4, and 8; pre-dose and 30 (±15) minutes post infusion on Day 15. The duration of each cycle for Cohort 1, 2, and 4 was 28 days and for Cohort 3 was 21 days. Infusion duration = 30 to 35 minutes. min=minutes D=Days C=Cycle

    2. PK Parameter: Cmax of Andecaliximab [Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)]

      Cmax is defined as the maximum concentration of drug.

    3. PK Parameter: AUClast of Andecaliximab [Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)]

      AUClast is defined as the area under the concentration versus time curve to the last measurable concentration of drug from time zero to the last observable concentration.

    4. PK Parameter: AUC0-336h of Andecaliximab [Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)]

      AUC0-336h is defined as the area under the concentration versus time curve from time zero to time 336 hour.

    5. Number of Participants With Positive Anti-Andecaliximab Antibodies [Pre-dose on Day 1 of Cycles 1, 2, 3, 5, 7 and every third cycle and anytime at EOT (82.4 weeks) and EOS visit (maximum: 3 years and 1 month) (Each Cycle= 28 days for Cohort 1, 2 and 4; 21 days for Cohort 3)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Must have been born in Japan and must not have lived outside of Japan for a period > 1 year in the 5 years prior to Day 1

    • Must be able to trace their maternal and paternal ancestry of parents and grandparents as ethnically Japanese

    • Histologically confirmed inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the GEJ) or relapsed gastric adenocarcinoma

    • Cohorts 1, 2, and 3: Human Epidermal Growth Factor Receptor 2 (HER2)-negative tumor (primary tumor or metastatic lesion). Enrollment in Cohort 4 is not restricted by HER2 status (adults with HER2-positive, HER2-negative, or unknown HER2 status are eligible)

    • Cohort 1: Prior antitumor therapy or cytotoxic chemotherapy is acceptable. Individuals who are not eligible to receive standard treatments should enroll on the study.

    • Cohorts 2 and 3: Prior antitumor therapy or cytotoxic chemotherapy for metastatic disease is not acceptable. Individuals must be chemo-naive in the metastatic setting

    • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

    • Adequate baseline organ function (within 28 days prior to Day 1)

    • Coagulation: International Normalized Ratio (INR) ≤ 1.5 (unless receiving anticoagulation therapy)

    • For females of childbearing potential, willingness to use a protocol-recommended method of contraception from the screening visit throughout the study treatment period and for defined periods following the last dose of andecaliximab and/or anti-cancer agent(s)

    • For males of childbearing potential having intercourse with females of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of andecaliximab, throughout the study treatment period, and for protocol defined periods following the last dose of andecaliximab and/or anti-cancer agent(s)

    • Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions

    • In addition to the applicable criteria above, participants in Cohort 4 must meet additional inclusion criteria to be eligible for participation in this study:

    • Measurable gastric or GEJ adenocarcinoma

    • Must have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease.

    • Activated partial thromboplastin (aPTT) ≤ 1.5 times the upper limit of normal

    • Thyroid function tests should be within normal limits.

    Key Exclusion Criteria:

    • History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator and medical monitor would pose a risk to participant safety or interfere with the study evaluations, procedures, or completion

    • Pregnant or lactating. Enrollment of lactating females after discontinuation of breastfeeding is not acceptable.

    • Individuals with known central nervous system (CNS) metastases, unless metastases are treated and stable and the individual does not require systemic steroids

    • Radiotherapy within 28 days of Day 1

    • Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of Day 1

    • History of major surgery within 28 days of Day 1

    • Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires IV antibiotics

    • Individuals known to be positive for human immunodeficiency virus (HIV), hepatitis C infection (per local standard diagnostic criteria), or acute or chronic hepatitis B infection (per local standard diagnostic criteria)

    • In addition to the applicable criteria above, participants in Cohort 4 who meet any of the following exclusion criteria will not be enrolled in this study

    • Have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma

    • Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) agents, anti-programmed cell death protein 1 (anti PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agents, anti-programmed cell death ligand 2 (anti-PD-L2) agents, anti-matrix metalloprotease (anti-MMP) agents, or other immunomodulatory therapies

    NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagoya Japan
    2 Osaka Japan
    3 Tokyo Japan

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02862535
    Other Study ID Numbers:
    • GS-US-296-1884
    First Posted:
    Aug 11, 2016
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Adenocarcinoma
    Oxaliplatin
    Nivolumab

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in Japan. The first participant was screened on 20 Sep 2016. The last study visit occurred on 25 Oct 2019.
    Pre-assignment Detail 39 participants were screened.
    Arm/Group Title Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Arm/Group Description Participants received andecaliximab (ADX) 800 mg as monotherapy via intravenous (IV) infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Period Title: Overall Study
    STARTED 9 6 10 11
    COMPLETED 0 0 0 0
    NOT COMPLETED 9 6 10 11

    Baseline Characteristics

    Arm/Group Title Cohort 1: ADX Cohort 2: ADX+S-1+Cisplatin Cohort 3: ADX+S-1+Oxaliplatin Cohort 4: ADX+Nivolumab Total
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Total of all reporting groups
    Overall Participants 8 6 10 10 34
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    59
    (14.7)
    69
    (7.9)
    56
    (15.1)
    63
    (11.8)
    61
    (13.3)
    Sex: Female, Male (Count of Participants)
    Female
    3
    37.5%
    1
    16.7%
    4
    40%
    1
    10%
    9
    26.5%
    Male
    5
    62.5%
    5
    83.3%
    6
    60%
    9
    90%
    25
    73.5%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    8
    100%
    6
    100%
    10
    100%
    10
    100%
    34
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    8
    100%
    6
    100%
    10
    100%
    10
    100%
    34
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
    Description TEAEs are any AEs with an onset date of on or after the date that ADX and if applicable, nivolumab was first administered and no later than 30 days after permanent discontinuation of ADX, or if applicable, 5 months after permanent discontinuation of nivolumab (whichever is later).
    Time Frame First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set included all participants who took at least 1 dose of study drug.
    Arm/Group Title Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8 6 10 10
    Number [percentage of participants]
    100.0
    1250%
    100.0
    1666.7%
    100.0
    1000%
    100.0
    1000%
    2. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
    Description Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the specified time frame (first dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)) was considered treatment-emergent.Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 was used for assigning toxicity grades to laboratory results for analysis.
    Time Frame First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set with available data were analyzed.
    Arm/Group Title Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8 6 10 10
    Any Laboratory abnormalities: Hematology
    87.5
    1093.8%
    83.3
    1388.3%
    90.0
    900%
    70.0
    700%
    Any Laboratory abnormalities: Chemistry
    100.0
    1250%
    100.0
    1666.7%
    100.0
    1000%
    80.0
    800%
    Any Laboratory abnormalities: Coagulation
    0
    0%
    0
    0%
    0
    0%
    10.0
    100%
    3. Secondary Outcome
    Title Cohort 1: Plasma Concentration of Andecaliximab
    Description Plasma concentration is defined as the measured drug concentration. Blood samples were drawn at pre-dose and 30 (±15) minutes after infusion on Day 1 of Cycles 2, 3, 5; End of study (EOS) (3 years and 1 month); Cycle 1 only: 30 (±15) minutes after infusion on Day 1; anytime on Day 2, 4, and 8; pre-dose and 30 (±15) minutes post infusion on Day 15. The duration of each cycle for Cohort 1, 2, and 4 was 28 days and for Cohort 3 was 21 days. Infusion duration = 30 to 35 minutes. min=minutes D=Days C=Cycle
    Time Frame Pre-dose and 30 (±15) min after infusion on C2D1, C3D1, C5D1; EOS (3 years and 1 month); C1 only: 30 (±15) min after infusion on D1; anytime on D2, D4 and D8; Pre-dose and 30 (±15) minutes post infusion on D15

    Outcome Measure Data

    Analysis Population Description
    The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory with available data were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
    Arm/Group Title Cohort 1: ADX
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8
    30 minutes Postdose: Cycle 1 Day 1
    262,625.0
    (57410.64)
    Postdose: Cycle 1 Day 2
    211,875.0
    (56688.21)
    Postdose: Cycle 1 Day 4
    133,100.0
    (57485.39)
    Postdose: Cycle 1 Day 8
    90100.0
    (18127.25)
    Predose: Cycle 1 Day 15
    54800.0
    (12011.66)
    30 minutes Postdose: Cycle 1 Day 15
    310,971.4
    (128,365.39)
    Predose: Cycle 2 Day 1
    122,200.0
    (52872.68)
    30 minutes Postdose: Cycle 2 Day 1
    458,666.7
    (211,613.64)
    Predose: Cycle 3 Day 1
    158,000.0
    (16970.56)
    30 minutes Postdose: Cycle 3 Day 1
    349,300.0
    (402,626.60)
    Predose: Cycle 5 Day 1
    154,500.0
    (6363.96)
    30 minutes Postdose: Cycle 5 Day 1
    510,500.0
    (136,471.61)
    End of study
    61960.0
    (37635.40)
    4. Secondary Outcome
    Title PK Parameter: Cmax of Andecaliximab
    Description Cmax is defined as the maximum concentration of drug.
    Time Frame Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
    Arm/Group Title Cohort 1: ADX
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8
    Mean (Standard Deviation) [micrograms per milliliter]
    264.0
    (56.42)
    5. Secondary Outcome
    Title PK Parameter: AUClast of Andecaliximab
    Description AUClast is defined as the area under the concentration versus time curve to the last measurable concentration of drug from time zero to the last observable concentration.
    Time Frame Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
    Arm/Group Title Cohort 1: ADX
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8
    Mean (Standard Deviation) [hours*micrograms per milliliter(h*μg/mL)]
    33500.2
    (8397.01)
    6. Secondary Outcome
    Title PK Parameter: AUC0-336h of Andecaliximab
    Description AUC0-336h is defined as the area under the concentration versus time curve from time zero to time 336 hour.
    Time Frame Cycle 1 only: 30 (± 15) minutes after the end of infusion on Day 1; anytime on Days 2, 4, and 8; prior to dosing on Day 15 (Cycle length= 28 days) (infusion duration= 30 to 35 minutes)

    Outcome Measure Data

    Analysis Population Description
    Participants in the PK Analysis Set with available data were analyzed. Due to program discontinuation data were not collected for Cohorts 2, 3, and 4.
    Arm/Group Title Cohort 1: ADX
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 7
    Mean (Standard Deviation) [h*μg/mL]
    34341.9
    (8697.66)
    7. Secondary Outcome
    Title Number of Participants With Positive Anti-Andecaliximab Antibodies
    Description
    Time Frame Pre-dose on Day 1 of Cycles 1, 2, 3, 5, 7 and every third cycle and anytime at EOT (82.4 weeks) and EOS visit (maximum: 3 years and 1 month) (Each Cycle= 28 days for Cohort 1, 2 and 4; 21 days for Cohort 3)

    Outcome Measure Data

    Analysis Population Description
    The Immunogenicity Analysis Set included all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose antidrug antibody status reported.
    Arm/Group Title Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    Measure Participants 8 6 10 10
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Adverse Events: First dose date up to 82.4 weeks plus 30 days (or if applicable, up to 5 months after permanent withdrawal of nivolumab) All-Cause Mortality: From study start date up to study completion date (3 years and 1 month)
    Adverse Event Reporting Description The Safety Analysis Set included all participants who took at least 1 dose of study drug.
    Arm/Group Title Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Arm/Group Description Participants received ADX 800 mg as monotherapy via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks on Days 1 and 15 of each 28-day treatment cycle in combination with chemotherapy (S-1 administered orally twice daily plus cisplatin administered via IV infusion on Day 8 of every 5 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug. Dose of S-1 and cisplatin was based upon participant condition, investigator discretion, institutional practice or in country label. Participants received ADX 1200 mg via IV infusion (approximately 30 minutes) every 3 weeks on Day 1 of each 21-day treatment cycle in combination with chemotherapy (S-1 administered at 80 mg/day to 120 mg/day according to the body surface area orally twice daily for first 14 days of 21 day cycle plus oxaliplatin administered via IV infusion at 100 mg/m^2 over 2 hours on Day 1 of each 21-day cycle) until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study. Participants received ADX 800 mg via IV infusion (approximately 30 minutes) every 2 weeks followed by chemotherapy (nivolumab 3 mg/kg via IV infusion [approximately 60 minutes] every 2 weeks) on Days 1 and 15 of each 28-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons prespecified in the protocol for discontinuation of study drug.
    All Cause Mortality
    Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/8 (87.5%) 3/6 (50%) 2/10 (20%) 5/10 (50%)
    Serious Adverse Events
    Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/8 (25%) 2/6 (33.3%) 1/10 (10%) 5/10 (50%)
    Blood and lymphatic system disorders
    Anaemia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    General disorders
    Malaise 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Pyrexia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hepatobiliary disorders
    Bile duct stenosis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Cholangitis 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hepatic function abnormal 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Investigations
    Blood bilirubin increased 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Metabolism and nutrition disorders
    Decreased appetite 1/8 (12.5%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Renal and urinary disorders
    Hydronephrosis 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    Cohort 1: ADX Cohort 2: ADX + S-1 + Cisplatin Cohort 3: ADX + S-1 + Oxaliplatin Cohort 4: ADX + Nivolumab
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/8 (100%) 6/6 (100%) 10/10 (100%) 10/10 (100%)
    Blood and lymphatic system disorders
    Anaemia 2/8 (25%) 2/6 (33.3%) 0/10 (0%) 1/10 (10%)
    Disseminated intravascular coagulation 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Iron deficiency anaemia 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Neutropenia 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Congenital, familial and genetic disorders
    Epidermolysis 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Ear and labyrinth disorders
    Deafness neurosensory 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Tinnitus 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Vertigo 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Endocrine disorders
    Hypothyroidism 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Eye disorders
    Blepharitis 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Conjunctivochalasis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Dacryostenosis acquired 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Abdominal pain 0/8 (0%) 1/6 (16.7%) 1/10 (10%) 2/10 (20%)
    Abdominal pain upper 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Anal inflammation 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Constipation 2/8 (25%) 2/6 (33.3%) 4/10 (40%) 1/10 (10%)
    Dental caries 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Diarrhoea 1/8 (12.5%) 4/6 (66.7%) 2/10 (20%) 2/10 (20%)
    Enteritis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Gastrooesophageal reflux disease 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Haemorrhoids 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Nausea 4/8 (50%) 5/6 (83.3%) 4/10 (40%) 2/10 (20%)
    Stomatitis 0/8 (0%) 3/6 (50%) 3/10 (30%) 3/10 (30%)
    Vomiting 1/8 (12.5%) 2/6 (33.3%) 1/10 (10%) 0/10 (0%)
    General disorders
    Fatigue 3/8 (37.5%) 2/6 (33.3%) 2/10 (20%) 3/10 (30%)
    General physical health deterioration 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Malaise 3/8 (37.5%) 1/6 (16.7%) 1/10 (10%) 0/10 (0%)
    Oedema peripheral 1/8 (12.5%) 0/6 (0%) 1/10 (10%) 1/10 (10%)
    Pyrexia 2/8 (25%) 2/6 (33.3%) 1/10 (10%) 2/10 (20%)
    Thirst 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Hepatobiliary disorders
    Bile duct stenosis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Cholangitis 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hepatic function abnormal 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Immune system disorders
    Contrast media allergy 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Infections and infestations
    Bronchitis 1/8 (12.5%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Conjunctivitis 0/8 (0%) 0/6 (0%) 1/10 (10%) 1/10 (10%)
    Enteritis infectious 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Enterocolitis infectious 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Herpes zoster 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Influenza 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Nasopharyngitis 0/8 (0%) 1/6 (16.7%) 1/10 (10%) 2/10 (20%)
    Oral herpes 0/8 (0%) 0/6 (0%) 1/10 (10%) 1/10 (10%)
    Pharyngitis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Pneumonia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Upper respiratory tract infection 0/8 (0%) 1/6 (16.7%) 2/10 (20%) 1/10 (10%)
    Injury, poisoning and procedural complications
    Arthropod bite 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Arthropod sting 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Fall 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Investigations
    Alanine aminotransferase increased 0/8 (0%) 0/6 (0%) 2/10 (20%) 1/10 (10%)
    Amylase increased 0/8 (0%) 0/6 (0%) 2/10 (20%) 0/10 (0%)
    Aspartate aminotransferase increased 0/8 (0%) 0/6 (0%) 3/10 (30%) 1/10 (10%)
    Blood bilirubin increased 0/8 (0%) 1/6 (16.7%) 1/10 (10%) 0/10 (0%)
    Blood creatine phosphokinase increased 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Blood thyroid stimulating hormone increased 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Neutrophil count decreased 0/8 (0%) 3/6 (50%) 3/10 (30%) 2/10 (20%)
    Platelet count decreased 0/8 (0%) 1/6 (16.7%) 5/10 (50%) 0/10 (0%)
    Weight decreased 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    White blood cell count decreased 0/8 (0%) 3/6 (50%) 4/10 (40%) 2/10 (20%)
    Metabolism and nutrition disorders
    Decreased appetite 3/8 (37.5%) 5/6 (83.3%) 5/10 (50%) 2/10 (20%)
    Hyperglycaemia 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Hyperuricaemia 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Hypoalbuminaemia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hypoglycaemia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hypokalaemia 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Hypomagnesaemia 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Hyponatraemia 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/8 (0%) 0/6 (0%) 0/10 (0%) 2/10 (20%)
    Back pain 0/8 (0%) 1/6 (16.7%) 1/10 (10%) 0/10 (0%)
    Myalgia 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Pain in extremity 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Malignant ascites 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Tumour associated fever 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Tumour pain 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Nervous system disorders
    Dysgeusia 0/8 (0%) 0/6 (0%) 2/10 (20%) 0/10 (0%)
    Headache 1/8 (12.5%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Peripheral sensory neuropathy 0/8 (0%) 1/6 (16.7%) 10/10 (100%) 1/10 (10%)
    Somnolence 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Vagus nerve disorder 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Psychiatric disorders
    Delirium 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Insomnia 0/8 (0%) 3/6 (50%) 0/10 (0%) 1/10 (10%)
    Renal and urinary disorders
    Haematuria 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Proteinuria 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 1/10 (10%)
    Renal impairment 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 1/8 (12.5%) 1/6 (16.7%) 1/10 (10%) 1/10 (10%)
    Dysphonia 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Dyspnoea 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Epistaxis 0/8 (0%) 0/6 (0%) 0/10 (0%) 2/10 (20%)
    Hiccups 0/8 (0%) 2/6 (33.3%) 0/10 (0%) 0/10 (0%)
    Hypoxia 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Interstitial lung disease 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Pneumonitis 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Pneumothorax 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 0/10 (0%)
    Skin and subcutaneous tissue disorders
    Alopecia 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Decubitus ulcer 1/8 (12.5%) 0/6 (0%) 0/10 (0%) 0/10 (0%)
    Dermatitis acneiform 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Dry skin 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Erythema 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Hyperhidrosis 0/8 (0%) 0/6 (0%) 0/10 (0%) 1/10 (10%)
    Palmar-plantar erythrodysaesthesia syndrome 0/8 (0%) 1/6 (16.7%) 1/10 (10%) 0/10 (0%)
    Pruritus 1/8 (12.5%) 0/6 (0%) 1/10 (10%) 1/10 (10%)
    Rash 1/8 (12.5%) 0/6 (0%) 1/10 (10%) 3/10 (30%)
    Rash maculo-papular 0/8 (0%) 2/6 (33.3%) 1/10 (10%) 2/10 (20%)
    Skin ulcer 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)
    Vascular disorders
    Hypertension 0/8 (0%) 1/6 (16.7%) 0/10 (0%) 1/10 (10%)
    Vascular pain 0/8 (0%) 0/6 (0%) 3/10 (30%) 0/10 (0%)
    Vasculitis 0/8 (0%) 0/6 (0%) 1/10 (10%) 0/10 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02862535
    Other Study ID Numbers:
    • GS-US-296-1884
    First Posted:
    Aug 11, 2016
    Last Update Posted:
    Dec 24, 2020
    Last Verified:
    Nov 1, 2020