FPA008-002: Study of Cabiralizumab in Patients With Pigmented Villonodular Synovitis / Diffuse Type Tenosynovial Giant Cell Tumor

Sponsor
Five Prime Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02471716
Collaborator
(none)
66
12
2
59
5.5
0.1

Study Details

Study Description

Brief Summary

This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

Condition or Disease Intervention/Treatment Phase
  • Biological: FPA008
Phase 1/Phase 2

Detailed Description

A Phase 1/2 study was an open-label, dose escalation and dose expansion study designed to evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of cabiralizumab, a CSF1-R monoclonal antibody, inpatients with unresectable diffuse tenosynovial giant cell tumors (TGCT).

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of Cabiralizumab, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1 FPA008 Dose Escalation

IV infusion; safety data will be reviewed prior to dose escalation decision. Dose escalation will complete when recommended dose (RD) is determined. RD will be the maximum tolerated dose or lower dose that provide adequate PK exposure and biologic activity with tolerability.

Biological: FPA008
FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
Other Names:
  • Cabiralizumab
  • Experimental: Phase 2 FPA008 Dose Expansion

    IV infusion; once MTD and/or RD has been determined in Phase 1, expansion cohorts of approximately 30 patients (each cohort) with PVNS or dt-TGCT will be enrolled to characterize clinical activity and safety profile of the RD. Treatment is planned to continue for up to 24 weeks or 56 weeks.

    Biological: FPA008
    FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
    Other Names:
  • Cabiralizumab
  • Outcome Measures

    Primary Outcome Measures

    1. The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1 [52 weeks]

      Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1

    2. The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2) [52 weeks]

      Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)

    Secondary Outcome Measures

    1. PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC) [52 weeks]

      Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter

    2. Maximum Serum Concentration (Cmax). [52 weeks]

      Composite PK parameters of cabiralizumab: Maximum observed serum concentration

    3. Minimum Serum Concentration (Cmin). [52 weeks]

      Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).

    4. Pharmacokinetic Clearance (CL). [52 weeks]

      Composite PK parameters of cabiralizumab: clearance (CL)

    5. The Incidence of AEs. [52 weeks]

      treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.

    6. The Incidence of Clinical Laboratory Abnormalities. [52 weeks]

      The number of patients with a clinical laboratory that is outside the normal range at some time point during the study

    7. The Incidence of ECG Abnormalities. [52 weeks]

      The number of patients who had a change in their ECG that were clinically significant

    8. Duration of Response Per RECIST 1.1 in Phase 2 [52 weeks]

      The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed diagnosis of inoperable PVNS/ dt-TGCT or potentially resectable tumor that would result in unacceptable functional loss or morbidity as determined by a qualified surgeon or multi-disciplinary tumor board (must be documented in the CRF during screening)

    • Measurable PVNS/dt-TGCT by RECIST 1.1 on MRI

    • ECOG performance status <1

    Exclusion Criteria:
    • Prior therapy with an anti-CSF1R antibody

    • Prior therapy with PLX3397 unless discontinued for intolerance (i.e., non-progression on prior kinase inhibitor)

    • Liver function tests (including ALT, AST, and total bilirubin), outside of the range of local laboratory normal at Screening

    • Inadequate organ or bone marrow function

    • History of congestive heart failure or myocardial infarction <1 year prior to first study dose administration

    • Significant abnormalities on ECG at Screening

    • Contraindications to MRI and use of intravenous gadolinium-based contrast agents

    • Creatine Kinase ≥ 1.5x the upper limit of normal

    • Positive test for latent TB at Screening (Quantiferon test)

    • Active known or suspected autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 Sarcoma Oncology Research Center LLC Santa Monica California United States 90403
    3 Stanford Medicine Stanford California United States 94301-5821
    4 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    5 The University of Texas, MD Anderson Cancer Center Houston Texas United States 77030
    6 Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest Bordeaux France 33076
    7 Centre Léon Bérard Lyon France 69008
    8 Seoul National University Hospital Seoul Jongno-gu Korea, Republic of 110-744
    9 Leiden University Medical Center Leiden Netherlands 2333 ZA
    10 Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie Warsaw Poland 02-781
    11 University Hospitals Birmingham NHS Foundation Trust Birmingham United Kingdom B15 2TH
    12 Oxford University Hospital NHS Trust Oxford United Kingdom OX3 7LE

    Sponsors and Collaborators

    • Five Prime Therapeutics, Inc.

    Investigators

    • Study Director: Medical Lead, Five Prime Therapeutics, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Five Prime Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02471716
    Other Study ID Numbers:
    • FPA008-002
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Five Prime Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Period Title: Overall Study
    STARTED 3 3 3 33 24
    COMPLETED 3 2 3 18 8
    NOT COMPLETED 0 1 0 15 16

    Baseline Characteristics

    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B Total
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1. Total of all reporting groups
    Overall Participants 3 3 3 33 24 66
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    100%
    2
    66.7%
    3
    100%
    32
    97%
    22
    91.7%
    62
    93.9%
    >=65 years
    0
    0%
    1
    33.3%
    0
    0%
    1
    3%
    2
    8.3%
    4
    6.1%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    37.7
    (11.24)
    40.7
    (23.07)
    41.7
    (7.51)
    38
    (12.77)
    44.1
    (15.32)
    40.8
    (14.03)
    Sex: Female, Male (Count of Participants)
    Female
    3
    100%
    3
    100%
    1
    33.3%
    23
    69.7%
    10
    41.7%
    40
    60.6%
    Male
    0
    0%
    0
    0%
    2
    66.7%
    10
    30.3%
    14
    58.3%
    26
    39.4%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian/alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    8.3%
    2
    3%
    Native Hawaiian/Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    3
    100%
    2
    66.7%
    2
    66.7%
    9
    27.3%
    9
    37.5%
    25
    37.9%
    Asian
    0
    0%
    1
    33.3%
    0
    0%
    5
    15.2%
    1
    4.2%
    7
    10.6%
    Other
    0
    0%
    0
    0%
    0
    0%
    19
    57.6%
    8
    33.3%
    27
    40.9%
    Unknown
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    4
    16.7%
    5
    7.6%

    Outcome Measures

    1. Primary Outcome
    Title The Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and Defined as Dose-limiting Toxicities (DLTs) in Phase 1
    Description Number of participants with grade 3 and grade 4 adverse events (AE) defined as dose limiting toxicities (DLTs) in Phase 1
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks
    Measure Participants 3 3 3
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title The Incidence of Investigator-assessed, Confirmed Objective Responses (ORR) Per RECIST 1.1 (Phase 2)
    Description Number of confirmed objective responses (ORR) as assessed by the investigator per RECIST 1.1 (Phase 2)
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 32 24
    Count of Participants [Participants]
    8
    266.7%
    8
    266.7%
    3. Secondary Outcome
    Title PK Parameters of Cabiralizumab: Area Under Concentration-time Curve (AUC)
    Description Area under serum concentration-time curve (AUC) for cabiralizumab as a PK parameter
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 2 1 2 3
    Geometric Mean (Geometric Coefficient of Variation) [ug x day/mL]
    102
    (10.2)
    283
    (26.3)
    593
    (31.3)
    660
    (17.7)
    593
    (12.6)
    4. Secondary Outcome
    Title Maximum Serum Concentration (Cmax).
    Description Composite PK parameters of cabiralizumab: Maximum observed serum concentration
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 3 3 30 24
    Geometric Mean (Geometric Coefficient of Variation) [ug/mL]
    22.5
    (14.3)
    52.1
    (22)
    91.2
    (15)
    91.8
    (24.8)
    87
    (12.6)
    5. Secondary Outcome
    Title Minimum Serum Concentration (Cmin).
    Description Composite PK parameters of cabiralizumab: minimum serum concentration (Cmin).
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 3 3 30 24
    Geometric Mean (Geometric Coefficient of Variation) [ug/mL]
    2.18
    (117)
    7.26
    (41.8)
    21.2
    (59.2)
    23.9
    (38.3)
    22.6
    (28.2)
    6. Secondary Outcome
    Title Pharmacokinetic Clearance (CL).
    Description Composite PK parameters of cabiralizumab: clearance (CL)
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 2 1 2 3
    Geometric Mean (Geometric Coefficient of Variation) [L/d]
    .663
    (16.6)
    .416
    (24.5)
    .694
    (0)
    .307
    (44.9)
    .525
    (8.42)
    7. Secondary Outcome
    Title The Incidence of AEs.
    Description treatment-emergent adverse events (TEAEs) by incidence for the Safety Population. Patients with at lease 1 TEAE.
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 3 3 33 24
    Count of Participants [Participants]
    3
    100%
    3
    100%
    3
    100%
    33
    100%
    24
    100%
    8. Secondary Outcome
    Title The Incidence of Clinical Laboratory Abnormalities.
    Description The number of patients with a clinical laboratory that is outside the normal range at some time point during the study
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 2 3 33 24
    Number [participants]
    3
    100%
    2
    66.7%
    3
    100%
    33
    100%
    24
    100%
    9. Secondary Outcome
    Title The Incidence of ECG Abnormalities.
    Description The number of patients who had a change in their ECG that were clinically significant
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    The changes in the ECG parameters were not clinically significant in any dosing cohort in the study
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 3 3 3 33 24
    Count of Participants [Participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    10. Secondary Outcome
    Title Duration of Response Per RECIST 1.1 in Phase 2
    Description The length of response per RECIST 1.1 from the time of first response to progression or going off study in Phase 2
    Time Frame 52 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    Measure Participants 8 8
    Median (95% Confidence Interval) [months]
    4.4
    NA

    Adverse Events

    Time Frame Event reporting commences at the time of signing the informed consent. A treatment-emergent AE was defined as an AE that began or worsened in severity after at least 1 dose of study drug had been administered. Adverse event reporting continued through the End-of-Treatment Follow-Up Period or until 90 days (± 7 days) after the last dose of study drug, the patient underwent local therapy (e.g., resection, radiation) or a new systemic therapy was initiated.
    Adverse Event Reporting Description
    Arm/Group Title Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Arm/Group Description Dose Escalation cohort: Dose level 1: 1 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 2: 2 mg/kg cabiralizumab every 2 weeks Dose Escalation cohort: Dose level 3: 3 mg/kg cabiralizumab every 2 weeks Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab every 2 weeks in 28-day cycles for up to 12 doses. Dose Expansion Cohort: patients were treated with 4 mg/kg cabiralizumab on Cycle 1 Day 1 and Cycle 1 Day 15 then every 4 weeks thereafter for up to 12 months after Cycle 1, Day 1.
    All Cause Mortality
    Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/32 (3.1%) 0/24 (0%)
    Serious Adverse Events
    Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 8/33 (24.2%) 6/24 (25%)
    Cardiac disorders
    Myocarditis /3 (NaN) /3 (NaN) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Congenital, familial and genetic disorders
    Twin reversed arterial perfusion sequence malformation /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Gastrointestinal disorders
    Abdominal pain /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Abdominal pain lower /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Colitis /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Diverticulum /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Abdominal pain upper /3 (NaN) /3 (NaN) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    General disorders
    Pyrexia /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Influenza like illness /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Systemic inflammatory response syndrome /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Hepatobiliary disorders
    Cholelithiasis /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Drug-induced liver injury /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Infections and infestations
    Lobar pneumonia /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Viral infection /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Streptococcal sepsis /3 (NaN) /3 (NaN) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Intervertebral discitis /3 (NaN) /3 (NaN) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Endocarditis /3 (NaN) /3 (NaN) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Sarcoma /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Nervous system disorders
    Cerebellar infarction /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Migraine /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Reproductive system and breast disorders
    Menorrhagia /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative /3 (NaN) /3 (NaN) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Skin atrophy /3 (NaN) /3 (NaN) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Vascular disorders
    Hypertension /3 (NaN) /3 (NaN) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Other (Not Including Serious) Adverse Events
    Phase 1 FPA008 Dose Escalation 1mg/kg Phase 1 FPA008 Dose Escalation 2mg/kg Phase 1 FPA008 Dose Escalation 4mg/kg Phase 2 FPA008 Dose Expansion Cohort 2A Phase 2 FPA008 Dose Expansion Cohort 2B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/3 (100%) 3/3 (100%) 3/3 (100%) 33/33 (100%) 24/24 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 0/24 (0%)
    Lymphadenopathy 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Neutropenia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Cardiac disorders
    Palpitations 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Sinus bradycardia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Sinus tachycardia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Ear and labyrinth disorders
    Hearing impaired 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Tinnitus 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Endocrine disorders
    Cushingoid 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Eye disorders
    Abnormal sensation in eye 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Conjunctival hyperaemia 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Conjunctival oedema 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Dry eye 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2/33 (6.1%) 1/24 (4.2%)
    Eye pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Eyelid oedema 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 6/33 (18.2%) 7/24 (29.2%)
    Eyelid rash 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Eyelid skin dryness 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Lacrimation increased 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 4/33 (12.1%) 5/24 (20.8%)
    Periorbital oedema 2/3 (66.7%) 2/3 (66.7%) 2/3 (66.7%) 20/33 (60.6%) 13/24 (54.2%)
    Photophobia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Scleritis 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Vision blurred 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 3/33 (9.1%) 5/24 (20.8%)
    Visual acuity reduced 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Gastrointestinal disorders
    Abdominal pain upper 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 2/24 (8.3%)
    Colitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Constipation 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/33 (3%) 0/24 (0%)
    Diarrhoea 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 1/24 (4.2%)
    Diarrhoea haemorrhagic 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Food poisoning 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Haemorrhoids 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Lip swelling 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Nausea 2/3 (66.7%) 0/3 (0%) 1/3 (33.3%) 5/33 (15.2%) 3/24 (12.5%)
    Oral pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Vomiting 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 4/33 (12.1%) 3/24 (12.5%)
    Abdominal discomfort 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Abdominal pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 0/24 (0%)
    Cheilitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Flatulence 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Lip oedema 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Salivary hypersecretion 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Stomatitis 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    General disorders
    Asthenia 0/3 (0%) 0/3 (0%) 0/3 (0%) 7/33 (21.2%) 5/24 (20.8%)
    Chest pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Chills 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Face oedema 0/3 (0%) 1/3 (33.3%) 2/3 (66.7%) 22/33 (66.7%) 12/24 (50%)
    Fatigue 2/3 (66.7%) 1/3 (33.3%) 3/3 (100%) 11/33 (33.3%) 8/24 (33.3%)
    Gait disturbance 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Generalised oedema 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Local swelling 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Non-cardiac chest pain 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Oedema 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 2/24 (8.3%)
    Oedema peripheral 2/3 (66.7%) 1/3 (33.3%) 2/3 (66.7%) 19/33 (57.6%) 8/24 (33.3%)
    Pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Peripheral swelling 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/33 (3%) 3/24 (12.5%)
    Pyrexia 0/3 (0%) 0/3 (0%) 0/3 (0%) 5/33 (15.2%) 1/24 (4.2%)
    Sensation of foreign body 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Swelling 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Localised oedema 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Hepatobiliary disorders
    Biliary colic 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Cholelithiasis 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Hepatic pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Hepatocellular injury 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Infections and infestations
    Abscess 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Acarodermatitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Cellulitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Conjunctivitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Ear infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Gastroenteritis 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Hordeolum 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Influenza 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Ophthalmic herpes zoster 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Oral candidiasis 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Otitis externa 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Pneumonia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Respiratory tract infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Urinary tract infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Viral infection 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Vulvovaginal candidiasis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Injury, poisoning and procedural complications
    Contusion 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Joint dislocation 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Joint injury 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Post procedural inflammation 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Investigations
    Activated partial thromboplastin time prolonged 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Alanine aminotransferase increased 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 6/33 (18.2%) 0/24 (0%)
    Aspartate aminotransferase increased 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 10/33 (30.3%) 3/24 (12.5%)
    Blood alkaline phosphatase increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Blood bilirubin increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Blood cholesterol increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 4/33 (12.1%) 0/24 (0%)
    Blood creatine phosphokinase increased 0/3 (0%) 1/3 (33.3%) 3/3 (100%) 21/33 (63.6%) 16/24 (66.7%)
    Blood lactate dehydrogenase increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 4/33 (12.1%) 3/24 (12.5%)
    Blood pressure increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    C-reactive protein increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Troponin I increased 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Weight increased 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 3/33 (9.1%) 2/24 (8.3%)
    Metabolism and nutrition disorders
    Decreased appetite 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Hypercalcaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Hypercholesterolaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 7/33 (21.2%) 1/24 (4.2%)
    Hyperglycaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Hypertriglyceridaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Hypoglycaemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Hypokalaemia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 1/33 (3%) 0/24 (0%)
    Hyponatraemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Hypophosphataemia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Increased appetite 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/3 (0%) 0/3 (0%) 0/3 (0%) 10/33 (30.3%) 3/24 (12.5%)
    Arthritis 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Back pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Flank pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Joint effusion 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Joint range of motion decreased 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Joint swelling 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 2/24 (8.3%)
    Knee deformity 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Lupus-like syndrome 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Mobility decreased 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Muscle spasms 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Musculoskeletal discomfort 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Musculoskeletal pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Musculoskeletal stiffness 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Myalgia 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 2/33 (6.1%) 3/24 (12.5%)
    Neck pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Pain in extremity 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Pain in jaw 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Rhabdomyolysis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Spinal pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Synovitis 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Haemangioma of bone 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Tumour pain 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 0/33 (0%) 0/24 (0%)
    Nervous system disorders
    Burning sensation 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Carpal tunnel syndrome 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Cervicobrachial syndrome 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Dizziness 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 3/24 (12.5%)
    Dysgeusia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Headache 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 7/33 (21.2%) 3/24 (12.5%)
    Hyperaesthesia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Hypoaesthesia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Migraine 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Neuralgia 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Neuropathy peripheral 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 0/24 (0%)
    Nystagmus 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Paraesthesia 0/3 (0%) 0/3 (0%) 0/3 (0%) 5/33 (15.2%) 2/24 (8.3%)
    Poor quality sleep 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Sciatica 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Tremor 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Psychiatric disorders
    Affective disorder 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Anxiety 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 2/24 (8.3%)
    Insomnia 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 2/24 (8.3%)
    Renal and urinary disorders
    Bladder spasm 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Dysuria 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Haematuria 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 1/24 (4.2%)
    Reproductive system and breast disorders
    Dysfunctional uterine bleeding 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Menometrorrhagia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Menorrhagia 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Menstruation irregular 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Pelvic pain 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 2/24 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 1/24 (4.2%)
    Dysphonia 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Dyspnoea 0/3 (0%) 0/3 (0%) 0/3 (0%) 4/33 (12.1%) 2/24 (8.3%)
    Dyspnoea exertional 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Epistaxis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Laryngeal oedema 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Nasal congestion 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Pleural effusion 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Productive cough 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Rhinitis allergic 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Rhinorrhoea 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 0/24 (0%)
    Sleep apnoea syndrome 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Wheezing 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Skin and subcutaneous tissue disorders
    Acne 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Cold sweat 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Dermatitis 2/3 (66.7%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 0/24 (0%)
    Dermatitis acneiform 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 0/24 (0%)
    Drug eruption 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Dry skin 0/3 (0%) 1/3 (33.3%) 2/3 (66.7%) 2/33 (6.1%) 4/24 (16.7%)
    Eczema 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Erythema 0/3 (0%) 0/3 (0%) 0/3 (0%) 5/33 (15.2%) 1/24 (4.2%)
    Generalised erythema 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Hirsutism 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Hyperhidrosis 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Macule 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Mechanical urticaria 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Night sweats 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Pain of skin 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Petechiae 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 1/24 (4.2%)
    Photosensitivity reaction 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Pruritus 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 17/33 (51.5%) 13/24 (54.2%)
    Pruritus generalised 1/3 (33.3%) 1/3 (33.3%) 1/3 (33.3%) 5/33 (15.2%) 1/24 (4.2%)
    Psoriasis 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Rash 1/3 (33.3%) 1/3 (33.3%) 2/3 (66.7%) 11/33 (33.3%) 10/24 (41.7%)
    Rash erythematous 0/3 (0%) 0/3 (0%) 0/3 (0%) 3/33 (9.1%) 1/24 (4.2%)
    Rash generalised 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 3/24 (12.5%)
    Rash macular 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 1/24 (4.2%)
    Rash maculo-papular 0/3 (0%) 1/3 (33.3%) 0/3 (0%) 8/33 (24.2%) 1/24 (4.2%)
    Rash papular 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Rash pruritic 1/3 (33.3%) 0/3 (0%) 0/3 (0%) 5/33 (15.2%) 1/24 (4.2%)
    Skin atrophy 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 3/24 (12.5%)
    Skin discolouration 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Skin disorder 0/3 (0%) 0/3 (0%) 2/3 (66.7%) 4/33 (12.1%) 5/24 (20.8%)
    Skin exfoliation 0/3 (0%) 0/3 (0%) 0/3 (0%) 0/33 (0%) 2/24 (8.3%)
    Skin hyperpigmentation 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Skin lesion 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 1/24 (4.2%)
    Skin striae 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Swelling face 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Urticaria 0/3 (0%) 0/3 (0%) 1/3 (33.3%) 3/33 (9.1%) 0/24 (0%)
    Xeroderma 0/3 (0%) 0/3 (0%) 0/3 (0%) 1/33 (3%) 0/24 (0%)
    Vascular disorders
    Hypertension 0/3 (0%) 0/3 (0%) 0/3 (0%) 2/33 (6.1%) 3/24 (12.5%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Medical
    Organization FivePrime Theraputics
    Phone 415-365-5600
    Email nick.mahasuwan@fiveprime.com
    Responsible Party:
    Five Prime Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02471716
    Other Study ID Numbers:
    • FPA008-002
    First Posted:
    Jun 15, 2015
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Jul 1, 2020