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CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

Sponsor
Daiichi Sankyo Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01199068
Collaborator
ICON Clinical Research (Industry)
15
Enrollment
1
Location
1
Arm
18
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: CS-7017+Erlotinib

Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily

Drug: CS-7017
CS-7017 from 0.25 mg to 0.50 mg twice daily
Other Names:
  • CS7017

    • Drug: Erlotinib
    Erlotinib 150 mg once daily
    Other Names:
  • Tarceva

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy [From post first dose to 30 days after last dose, up to approximately 1.5 years]

      A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.

    2. Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer [Cycle 1, Week 1 and Cycle 2, Week 4]

      After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.

    3. Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer [Cycle 1, Week 1 and Cycle 2, Week 4]

      After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.

    4. Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer [Cycle 1, Week 1 and Cycle 2, Week 4]

      After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.

    Secondary Outcome Measures

    1. Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy [From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 years]

      As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as ≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR.

    2. Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy [From randomization to PD or death, up to approximately 1.5 years]

      Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first.

    3. Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy [From post first dose to 30 days after last dose, up to approximately 1.5 years]

      A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)

    • Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy

    • Male or female ≥ 18 years of age

    • Anticipation of more than 3 months survival

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

    • Adequate organ and bone marrow function

    Exclusion Criteria:

    • Prior Tyrosine Kinase Inhibitor (TKI) therapy

    • Anticipation of need for a major surgical procedure or radiation therapy during the study

    • Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment

    • Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment

    • History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe Chronic-Obstructive Pulmonary Disease (COPD) or asthma)

    • Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy

    • Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)

    • Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy

    • Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction

    • Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications

    • Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study treatment

    • History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin

    • Poorly-controlled blood pressure as judged by the Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Songpa-Gu Korea, Republic of 138-736

    Sponsors and Collaborators

    • Daiichi Sankyo Co., Ltd.
    • ICON Clinical Research

    Investigators

    • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daiichi Sankyo Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01199068
    Other Study ID Numbers:
    • CS7017-A-A110
    First Posted:
    Sep 10, 2010
    Last Update Posted:
    May 13, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Daiichi Sankyo Co., Ltd.
    PPAR gamma agonist
    Tumor
    Cancer
    Antineoplastic Agent
    Respiratory Tract Neoplasms
    Erlotinib
    Protein Kinase Inhibitors
    Neoplasms
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Erlotinib Hydrochloride
    Efatutazone

    Study Results

    Participant Flow

    Recruitment Details A total of 15 participants who met all inclusion and no exclusion criteria were enrolled in the study. Fourteen participants received treatment.
    Pre-assignment Detail This study consisted of 2 parts: initial portion and additional portion. In the initial portion, participants received CS-7017 (starting dose 0.25 mg BID ascending to 0.50 mg BID) in combination with erlotinib. In the additional portion, participants received CS-7017 0.50 mg BID in combination with erlotinib.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.
    Period Title: Overall Study
    STARTED 3 3 9
    Received Treatment 3 3 8
    COMPLETED 0 0 0
    NOT COMPLETED 3 3 9

    Baseline Characteristics

    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion Total
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Total of all reporting groups
    Overall Participants 3 3 8 14
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    100%
    3
    100%
    7
    87.5%
    13
    92.9%
    >=65 years
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.3
    (8.39)
    53.3
    (4.04)
    60.0
    (9.89)
    57.4
    (8.72)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    33.3%
    3
    37.5%
    4
    28.6%
    Male
    3
    100%
    2
    66.7%
    5
    62.5%
    10
    71.4%
    Region of Enrollment (participants) [Number]
    South Korea
    3
    100%
    3
    100%
    8
    100%
    14
    100%

    Outcome Measures

    1. Primary Outcome
    Title CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
    Description A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.
    Time Frame From post first dose to 30 days after last dose, up to approximately 1.5 years

    Outcome Measure Data

    Analysis Population Description
    CS-7017-related TEAEs were assessed in the Safety Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). All participants who received CS-71017 in combination with erlotinib.
    Measure Participants 3 3 8 11 14
    At least one CS-7017-Relaed TEAE
    2
    66.7%
    2
    66.7%
    8
    100%
    10
    71.4%
    12
    NaN
    Blood and Lymphatic System Disorders
    1
    33.3%
    1
    33.3%
    4
    50%
    5
    35.7%
    6
    NaN
    Anaemia
    0
    0%
    1
    33.3%
    4
    50%
    5
    35.7%
    5
    NaN
    Thrombocytopenia
    1
    33.3%
    0
    0%
    1
    12.5%
    1
    7.1%
    2
    NaN
    Neutropenia
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    1
    NaN
    Metabolism and Nutrition Disorders
    0
    0%
    0
    0%
    5
    62.5%
    5
    35.7%
    5
    NaN
    Decreased appetite
    0
    0%
    0
    0%
    4
    50%
    4
    28.6%
    4
    NaN
    Hypokalaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Hyponatraemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Eye Disorders
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Conjunctival hyperaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Cardiac Disorders
    0
    0%
    0
    0%
    3
    37.5%
    3
    21.4%
    3
    NaN
    Pericardial effusion
    0
    0%
    0
    0%
    3
    37.5%
    3
    21.4%
    3
    NaN
    Sinus arrhythmia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Respiratory, Thoracic, and Mediastinal Disorders
    0
    0%
    0
    0%
    3
    37.5%
    3
    21.4%
    3
    NaN
    Pleural effusion
    0
    0%
    0
    0%
    3
    37.5%
    3
    21.4%
    3
    NaN
    Gastrointestinal Disorders
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Nausea
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Renal and Urinary Disorders
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Azotaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Congenital, Familial, and Genetic Disorders
    0
    0%
    1
    33.3%
    0
    0%
    1
    7.1%
    1
    NaN
    Hydrocele
    0
    0%
    1
    33.3%
    0
    0%
    1
    7.1%
    1
    NaN
    General Disorders & Administration Site Conditions
    2
    66.7%
    1
    33.3%
    8
    100%
    9
    64.3%
    11
    NaN
    Face oedema
    2
    66.7%
    1
    33.3%
    8
    100%
    9
    64.3%
    11
    NaN
    Oedema peripheral
    1
    33.3%
    1
    33.3%
    5
    62.5%
    6
    42.9%
    7
    NaN
    Fatigue
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Generalised oedema
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Malaise
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Investigations
    1
    33.3%
    1
    33.3%
    7
    87.5%
    8
    57.1%
    9
    NaN
    Weight increased
    1
    33.3%
    1
    33.3%
    7
    87.5%
    8
    57.1%
    9
    NaN
    Blood creatinine increased
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Blood creatinine phosphokinase increased
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Brain natriuretic peptide increased
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Electrocardiogram QT prolonged
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    2. Primary Outcome
    Title Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
    Description After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.
    Time Frame Cycle 1, Week 1 and Cycle 2, Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial + Additional Portions
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
    Measure Participants 3 11
    Cycle 1, Week 1: AUClast
    50.8
    (38.6)
    148
    (84.3)
    Cycle 1, Week 1: AUCtau
    97.2
    (45.8)
    205
    (115)
    Cycle 2, Week 4: AUClast
    124
    (22.8)
    212
    (104)
    Cycle 2, Week 4: AUCtau
    174
    (27.0)
    307
    (156)
    3. Primary Outcome
    Title Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
    Description After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.
    Time Frame Cycle 1, Week 1 and Cycle 2, Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial + Additional Portions
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
    Measure Participants 3 11
    Cycle 1, Week 1: Cmax
    9.98
    (6.20)
    25.1
    (14.0)
    Cycle 2, Week 4: Cmax,ss
    18.9
    (3.75)
    32.4
    (16.0)
    4. Primary Outcome
    Title Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer
    Description After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.
    Time Frame Cycle 1, Week 1 and Cycle 2, Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial + Additional Portions
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).
    Measure Participants 3 11
    Cycle 1, Week 1: Tmax
    3.00
    3.00
    Cycle 2, Week 4: Tmax,ss
    3.50
    3.00
    5. Secondary Outcome
    Title Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
    Description As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as ≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR.
    Time Frame From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 years

    Outcome Measure Data

    Analysis Population Description
    Best overall response and response rate were assessed in the Efficacy Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). All participants who received CS-71017 in combination with erlotinib.
    Measure Participants 2 3 7 10 12
    Partial response (PR)
    0
    0%
    0
    0%
    5
    62.5%
    5
    35.7%
    5
    NaN
    Stable disease (SD)
    2
    66.7%
    1
    33.3%
    1
    12.5%
    2
    14.3%
    4
    NaN
    Progressive disesae (PD)
    0
    0%
    2
    66.7%
    1
    12.5%
    3
    21.4%
    3
    NaN
    Response rate (CR+PR)
    0
    0%
    0
    0%
    5
    62.5%
    5
    35.7%
    5
    NaN
    6. Secondary Outcome
    Title Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
    Description Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first.
    Time Frame From randomization to PD or death, up to approximately 1.5 years

    Outcome Measure Data

    Analysis Population Description
    Per-protocol Progression-free Survival Time data was only assessed in the 0.50 mg BID (additional portion) and the 0.5 mg BID (initial and additional portions) Groups.
    Arm/Group Title CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Arm/Group Description Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). All participants who received CS-71017 in combination with erlotinib.
    Measure Participants 7 10 12
    Median (95% Confidence Interval) [days]
    125
    82
    84
    7. Secondary Outcome
    Title Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy
    Description A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship
    Time Frame From post first dose to 30 days after last dose, up to approximately 1.5 years

    Outcome Measure Data

    Analysis Population Description
    Erlotinib-related TEAEs were assessed in the Safety Analysis Set.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). All participants who received CS-71017 in combination with erlotinib.
    Measure Participants 3 3 8 11 14
    At least one erolitinib-related TEAE
    3
    100%
    3
    100%
    8
    100%
    11
    78.6%
    14
    NaN
    Infections and Infestations
    1
    33.3%
    0
    0%
    1
    12.5%
    1
    7.1%
    2
    NaN
    Paronychia
    1
    33.3%
    0
    0%
    1
    12.5%
    1
    7.1%
    2
    NaN
    Blood and Lymphatic System Disorders
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Anaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Metabolism and Nutrition Disorders
    0
    0%
    0
    0%
    4
    50%
    4
    28.6%
    4
    NaN
    Decreased appetite
    0
    0%
    0
    0%
    4
    50%
    4
    28.6%
    4
    NaN
    Eye Disorders
    0
    0%
    0
    0%
    3
    37.5%
    3
    21.4%
    3
    NaN
    Blepharitis
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Conjunctival hyperaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Dry eye
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Respiratory, Thoracic, and Mediastinal Disorders
    0
    0%
    1
    33.3%
    2
    25%
    3
    21.4%
    3
    NaN
    Nasal dryness
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Nasal inflammation
    0
    0%
    1
    33.3%
    0
    0%
    1
    7.1%
    1
    NaN
    Oropharyngeal pain
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Gastrointestinal Disorders
    1
    33.3%
    2
    66.7%
    8
    100%
    10
    71.4%
    11
    NaN
    Diarrhoea
    1
    33.3%
    2
    66.7%
    6
    75%
    8
    57.1%
    9
    NaN
    Nausea
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Anorectal discomfort
    0
    0%
    1
    33.3%
    0
    0%
    1
    7.1%
    1
    NaN
    Flatulence
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Stomatitis
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Skin and Subcutaneous Tissue Disorders
    3
    100%
    2
    66.7%
    8
    100%
    10
    71.4%
    13
    NaN
    Skin exfoliation
    2
    66.7%
    1
    33.3%
    6
    75%
    7
    50%
    9
    NaN
    Dry skin
    2
    66.7%
    1
    33.3%
    5
    62.5%
    6
    42.9%
    8
    NaN
    Rash
    0
    0%
    0
    0%
    7
    87.5%
    7
    50%
    7
    NaN
    Dermatitis acneiform
    3
    100%
    2
    66.7%
    1
    12.5%
    3
    21.4%
    6
    NaN
    Pruritus
    2
    66.7%
    1
    33.3%
    3
    37.5%
    4
    28.6%
    6
    NaN
    Alopecia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Renal and Urinary Disorders
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    Azotaemia
    0
    0%
    0
    0%
    1
    12.5%
    1
    7.1%
    1
    NaN
    General Disorders & Administration Site Conditions
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Fatigue
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Investigations
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN
    Blood creatinine increased
    0
    0%
    0
    0%
    2
    25%
    2
    14.3%
    2
    NaN

    Adverse Events

    Time Frame Treatment-emergent adverse event data were collected from after the first dose up to 30 days after the last dose, up to approximately 1.5 years in the Safety Analysis Set.
    Adverse Event Reporting Description Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.
    Arm/Group Title CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Arm/Group Description Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily. Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions). All participants who received CS-71017 in combination with erlotinib.
    All Cause Mortality
    CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/3 (33.3%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 2/14 (14.3%)
    Serious Adverse Events
    CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/3 (33.3%) 3/3 (100%) 4/8 (50%) 7/11 (63.6%) 8/14 (57.1%)
    Cardiac disorders
    Pericardial effusion 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Gastrointestinal disorders
    Pancreatitis 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Abdominal pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Peptic ulcer 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    General disorders
    Chest pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Infections and infestations
    Pneumonia 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 2/14 (14.3%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Nervous system disorders
    Syncope 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Renal and urinary disorders
    Azotaemia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Bronchial haemorrhage 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Vascular disorders
    Orthostatic hypotension 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Other (Not Including Serious) Adverse Events
    CS-7017 0.25 mg BID; Initial Portion CS-7017 0.50 mg BID; Initial Portion CS-7017 0.50 mg BID; Additional Portion CS-7017 0.50 mg BID; Initial + Additional Portions Overall
    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%) 8/8 (100%) 11/11 (100%) 14/14 (100%)
    Blood and lymphatic system disorders
    Anaemia 1/3 (33.3%) 2/3 (66.7%) 5/8 (62.5%) 7/11 (63.6%) 8/14 (57.1%)
    Thrombocytopenia 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 2/14 (14.3%)
    Neutropenia 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Cardiac disorders
    Pericardial effusion 0/3 (0%) 0/3 (0%) 3/8 (37.5%) 3/11 (27.3%) 3/14 (21.4%)
    Sinus arrhythmia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Congenital, familial and genetic disorders
    Hydrocele 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Eye disorders
    Blepharitis 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Conjunctival hyperaemia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Dry eye 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Vision blurred 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Gastrointestinal disorders
    Diarrhoea 1/3 (33.3%) 2/3 (66.7%) 6/8 (75%) 8/11 (72.7%) 9/14 (64.3%)
    Abdominal discomfort 0/3 (0%) 1/3 (33.3%) 3/8 (37.5%) 4/11 (36.4%) 4/14 (28.6%)
    Abdominal pain upper 1/3 (33.3%) 2/3 (66.7%) 1/8 (12.5%) 3/11 (27.3%) 4/14 (28.6%)
    Dyspepsia 0/3 (0%) 2/3 (66.7%) 2/8 (25%) 4/11 (36.4%) 4/14 (28.6%)
    Nausea 0/3 (0%) 1/3 (33.3%) 3/8 (37.5%) 4/11 (36.4%) 4/14 (28.6%)
    Abdominal distension 1/3 (33.3%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 3/14 (21.4%)
    Anal haemorrhage 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 2/14 (14.3%)
    Constipation 0/3 (0%) 2/3 (66.7%) 0/8 (0%) 2/11 (18.2%) 2/14 (14.3%)
    Flatulence 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Vomiting 1/3 (33.3%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 2/14 (14.3%)
    Abdominal pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Anal pruritus 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Anorectal discomfort 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Ascites 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Gastritis atropic 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Pancreatitis 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Peptic ulcer 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Retching 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Stomatitis 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Toothache 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    General disorders
    Face oedema 2/3 (66.7%) 1/3 (33.3%) 8/8 (100%) 9/11 (81.8%) 11/14 (78.6%)
    Oedema peripheral 1/3 (33.3%) 2/3 (66.7%) 5/8 (62.5%) 7/11 (63.6%) 8/14 (57.1%)
    Fatigue 1/3 (33.3%) 1/3 (33.3%) 3/8 (37.5%) 4/11 (36.4%) 5/14 (35.7%)
    Asthenia 1/3 (33.3%) 1/3 (33.3%) 2/8 (25%) 3/11 (27.3%) 4/14 (28.6%)
    Generalised oedema 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Chest discomfort 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Chest pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Malaise 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Puncture site pain 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Pyrexia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Infections and infestations
    Paronychia 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 2/14 (14.3%)
    Pneumonia 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 2/14 (14.3%)
    Injury, poisoning and procedural complications
    Fall 1/3 (33.3%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 2/14 (14.3%)
    Investigations
    Weight increased 2/3 (66.7%) 1/3 (33.3%) 7/8 (87.5%) 8/11 (72.7%) 10/14 (71.4%)
    Blood creatinine phosphokinase increased 2/3 (66.7%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 3/14 (21.4%)
    Blood creatinine increased 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Weight decreased 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Blood bilirubin increased 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Blood cholesterol increased 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Blood lactate dehydrogenase increased 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Brain natriuretic peptide increased 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Electrocardiogram QC prolonged 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Metabolism and nutrition disorders
    Decreased appetite 1/3 (33.3%) 2/3 (66.7%) 6/8 (75%) 8/11 (72.7%) 9/14 (64.3%)
    Hyponatraemia 0/3 (0%) 0/3 (0%) 3/8 (37.5%) 3/11 (27.3%) 3/14 (21.4%)
    Hypokalaemia 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Hypertriglyceridaemia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Hypoalbuminaemia 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/3 (0%) 3/3 (100%) 1/8 (12.5%) 4/11 (36.4%) 4/14 (28.6%)
    Muscular weakness 1/3 (33.3%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 3/14 (21.4%)
    Arthralgia 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 2/14 (14.3%)
    Musculoskeletal pain 1/3 (33.3%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 2/14 (14.3%)
    Myalgia 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 2/14 (14.3%)
    Pain in extremity 0/3 (0%) 2/3 (66.7%) 0/8 (0%) 2/11 (18.2%) 2/14 (14.3%)
    Flank pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Musculoskeletal discomfort 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Neck pain 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to abdominal cavity 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Metastatic pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Nervous system disorders
    Dizziness 0/3 (0%) 1/3 (33.3%) 4/8 (50%) 5/11 (45.5%) 5/14 (35.7%)
    Headache 0/3 (0%) 1/3 (33.3%) 1/8 (12.5%) 2/11 (18.2%) 2/14 (14.3%)
    Peripheral sensory neuropathy 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Syncope 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Psychiatric disorders
    Anxiety 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Confusional state 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Insomnia 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Depressed level of consciousness 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Renal and urinary disorders
    Azotaemia 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Dysuria 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Reproductive system and breast disorders
    Scrotal pain 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Scrotal swelling 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/3 (0%) 2/3 (66.7%) 5/8 (62.5%) 7/11 (63.6%) 7/14 (50%)
    Dyspnoea 0/3 (0%) 3/3 (100%) 4/8 (50%) 7/11 (63.6%) 7/14 (50%)
    Haemoptysis 0/3 (0%) 2/3 (66.7%) 1/8 (12.5%) 3/11 (27.3%) 3/14 (21.4%)
    Pleural effusion 0/3 (0%) 0/3 (0%) 3/8 (37.5%) 3/11 (27.3%) 3/14 (21.4%)
    Productive cough 0/3 (0%) 2/3 (66.7%) 1/8 (12.5%) 3/11 (27.3%) 3/14 (21.4%)
    Rhinorrhoea 0/3 (0%) 0/3 (0%) 3/8 (37.5%) 3/11 (27.3%) 3/14 (21.4%)
    Dysphonia 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Bronchial haemorrhage 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Hiccups 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Nasal dryness 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Nasal inflammation 0/3 (0%) 1/3 (33.3%) 0/8 (0%) 1/11 (9.1%) 1/14 (7.1%)
    Oropharyngeal pain 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Pneumothorax 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Skin and subcutaneous tissue disorders
    Skin exfoliation 2/3 (66.7%) 1/3 (33.3%) 6/8 (75%) 7/11 (63.6%) 9/14 (64.3%)
    Dry skin 2/3 (66.7%) 1/3 (33.3%) 5/8 (62.5%) 6/11 (54.5%) 8/14 (57.1%)
    Rash 0/3 (0%) 0/3 (0%) 7/8 (87.5%) 7/11 (63.6%) 7/14 (50%)
    Dermatitis acneiform 3/3 (100%) 2/3 (66.7%) 1/8 (12.5%) 3/11 (27.3%) 6/14 (42.9%)
    Pruritus 2/3 (66.7%) 1/3 (33.3%) 3/8 (37.5%) 4/11 (36.4%) 6/14 (42.9%)
    Alopecia 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Decubitus ulcer 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Ecchymosis 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Petechiae 1/3 (33.3%) 0/3 (0%) 0/8 (0%) 0/11 (0%) 1/14 (7.1%)
    Vascular disorders
    Hypotension 0/3 (0%) 0/3 (0%) 2/8 (25%) 2/11 (18.2%) 2/14 (14.3%)
    Orthostatic hypotension 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)
    Peripheral coldness 0/3 (0%) 0/3 (0%) 1/8 (12.5%) 1/11 (9.1%) 1/14 (7.1%)

    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 Contact for Clinical Trial Information
    Organization Daiichi Sankyo
    Phone 908-992-6400
    Email CTRinfo@dsi.com
    Responsible Party:
    Daiichi Sankyo Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01199068
    Other Study ID Numbers:
    • CS7017-A-A110
    First Posted:
    Sep 10, 2010
    Last Update Posted:
    May 13, 2021
    Last Verified:
    Apr 1, 2021