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TerminatedNCT00986440Updated Nov 5, 2020Results posted

Study of CS-7017 in Colorectal Cancer Patients Who Have Achieved Disease Control Following First-Line Chemotherapy

A Phase 2 interventional study of CS-7017 and Placebo in Colorectal Cancer, sponsored by Daiichi Sankyo. Terminated at 39 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by Daiichi Sankyo · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to changes to the standard of care within the proposed market for CS-7017.
Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Monotherapy treatment with CS-7017 to assess progression-free-survival (PFS) of subjects who achieved an objective response of Disease Control on first line therapy with Folinic acid (leucovorin), Fluorouracil (5-FU), Oxaliplatin (Eloxatin) known as FOLFOX; or Folinic acid (leucovorin), Fluorouracil (5-FU), irinotecan (Camptosar) known as FOLFIRI.

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 84 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with histologically confirmed, metastatic CRC that have achieved confirmed maximal benefit of DC following treatment with standard first line chemotherapy of a 5-fluoropyrimidine plus either oxaliplatin or irinotecan. Patients should be entered onto this trial within 8 weeks of completing first line therapy;
  • If CR was not achieved: measurable disease, i.e. at minimum one unidimensionally-measurable target lesion according to RECIST (Response Evaluation Criteria in Solid Tumors);
  • Age >= 18 years and Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2 at study entry;
  • Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 3.0, grade =\< 1;

  • Adequate organ and bone marrow function as evidenced by:

    • Haemoglobin >= 10 g/dL (transfusion and/or growth factor support allowed);
    • Absolute neutrophil count (ANC) >= 1.5 x 109/L;
    • Platelet count >= 100 x 109/L;
    • Serum creatinine =\< 1.5 x ULN or creatinine clearance >60 mL/min;
    • AST and alkaline phosphatase \<2.5 x ULN if without liver metastasis and =\< 5.0 x ULN if liver metastasis;
    • Total bilirubin =\< 2.0 x ULN;
    • Prothrombin time (PT)/International Normalised Ratio (INR) within normal limits (WNL) unless therapeutically anticoagulated;
  • Women of childbearing potential and men must be willing to consent to using highly effective methods of contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on treatment and for at least 3 months thereafter;
  • Males with the potential to father children must use two of the following methods of contraception acceptable for the study (e.g. hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
  • All female subjects of childbearing potential must have a negative pregnancy test (plasma or urine) result within 7 days before initiating study treatment;
  • Baseline laboratory tests and tumor assessments must have been performed within 2 weeks before initiating study treatment;
  • Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IEC-approved ICF before performance of any study specific procedures or tests.

Exclusion criteria

Exclusion Criteria:

  • Anticipation of need for a major surgical procedure or RT during the study;
  • Treatment with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment.
  • History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents;
  • Concomitant use of other TZDs;
  • Myocardial infarction with significant impairment of cardiac function (e.g., ejection fraction =\< 50%); severe/unstable angina pectoris; coronary/peripheral artery bypass graft; congestive heart failure; cerebrovascular accident (CVA) or transient ischemic attack (TIA), pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe chronic obstructive pulmonary disease [COPD] or asthma);
  • Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis;
  • Pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor;
  • Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;
  • Pregnant or breast feeding;
  • Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations;
  • Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    CS-7017

    Drug: CS-7017

  • Placebo comparator
    Placebo

    Placebo matching CS-7017

    Drug: Placebo

Interventions

  • DrugCS-7017

    CS-7017

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.

    Time frame: 18 weeks postdose

Secondary outcomes

  1. Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.

    Time frame: At 12, 24, and 30 weeks postdose

  2. Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.

    Time frame: At 3, 6, 9, and 12 months postdose

  3. Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.0, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

    Time frame: From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months

  4. Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. Duration of response was estimated using Kaplan Meier methods.

    Time frame: From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months

  5. Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

    A treatment-emergent adverse event (TEAE) was 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. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.

    Time frame: Baseline up to 30 days after last study dose, up to 3 years 3 months

07

Results

Posted Nov 5, 2020
Limitations and caveats
Early termination was due to changes in the standard of care within the proposed market. The study was designed when patient monitoring and no treatment was an option that will not support a confirmatory Phase 3 study. No safety or efficacy concerns.

Participant flow

A total of 84 participants who met all inclusion criteria and no exclusion criteria were enrolled at 46 clinic sites in Europe. Of the 84 participants enrolled, 83 received treatment.

Participant flow — Overall Study
MilestoneCS-7017 0.5 mgPlacebo
Started4143
Randomized, but not dosed01
Completed00
Not completed4143
Withdrew: Progressive disease2737
Withdrew: Serious adverse event or adverse event92
Withdrew: Withdrawal by subject12
Withdrew: Screen failure (not dosed)42

Outcome measures

PrimaryPercentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.

Time frame:
18 weeks postdose
Reported as:
Number · percentage of participants
Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
percentage of participantsCS-7017 0.5 mgPlacebo
Percentage Rate of Progression-free Survival at 18 Weeks Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy39.86 (23.5 to 55.7)25.00 (13.0 to 39.0)
Statistical analysis
  • CS-7017 0.5 mg vs Placebo · 2-sided P value for z test · p = <0.0001 · Z statistic for difference: 3.92
  • CS-7017 0.5 mg vs Placebo · Hazard ratio, log: -0.41
SecondaryPercentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

Progression-free survival (PFS) was defined as the time from enrollment to the date of the first objective documentation of disease progression or death resulting from any cause, whichever comes first. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions.

Time frame:
At 12, 24, and 30 weeks postdose
Reported as:
Number · percentage of participants
Percentage Rate of Progression-free Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
percentage of participantsCS-7017 0.5 mgPlacebo
Progression-free survival at 12 weeks62.0 (44.6 to 75.5)47.5 (31.6 to 61.8)
Progression-free survival at 24 weeks29.9 (15.4 to 45.9)15.0 (6.1 to 27.6)
Progression-free survival at 30 weeks29.9 (15.4 to 45.9)12.5 (4.6 to 24.6)
Statistical analysis
  • CS-7017 0.5 mg vs Placebo · Log Rank · p = 0.0380
  • CS-7017 0.5 mg vs Placebo · Peto-Peto-Prentice · p = 0.1773
  • CS-7017 0.5 mg vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.2844
  • CS-7017 0.5 mg vs Placebo · Tarone-Ware · p = 0.1140
SecondaryPercentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

Overall survival (OS) was defined as the time from the date of enrollment to the date of death and assessed by Kaplan Meier analysis.

Time frame:
At 3, 6, 9, and 12 months postdose
Reported as:
Number · percentage of participants
Percentage Rate of Overall Survival Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
percentage of participantsCS-7017 0.5 mgPlacebo
Overall survival rate at 3 months100.0 (100.0 to 100.0)92.9 (79.5 to 97.6)
Overall survival rate at 6 months87.2 (71.9 to 94.5)85.5 (70.4 to 93.2)
Overall survival rate at 9 months74.4 (57.6 to 85.3)75.2 (58.7 to 85.8)
Overall survival rate at 12 months68.4 (51.0 to 80.7)55.4 (37.2 to 70.3)
Statistical analysis
  • CS-7017 0.5 mg vs Placebo · Log Rank · p = 0.1213
SecondaryBest Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], unconfirmed CR, unconfirmed PR, stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.0, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Time frame:
From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to approximately 3 years 3 months
Reported as:
Count of participants · Participants
Best Overall Response and Objective Response Rate Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
ParticipantsCS-7017 0.5 mgPlacebo
Confirmed CR51
Confirmed PR10
Objective response (confirmed CR+PR)61
Unconfirmed CR00
Unconfirmed PR03
Stable disease108
Progressive disease2027
Inevaluable33
Best overall response of SD or better1612
SecondaryDuration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

Duration of response was defined for participants with confirmed CR or PR and confirmed and unconfirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. Duration of response was estimated using Kaplan Meier methods.

Time frame:
From the date of first objective response (confirmed and unconfirmed CR or PR) to date of progressive disease, up to 3 years 3 months
Reported as:
Mean · weeks
Duration of Response for Responding Participants Following Use of CS-7017 in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
weeksCS-7017 0.5 mgPlacebo
Duration of response (confirmed responses)33.57 ± 25.8837.86 ± NA
Duration of response (confirmed and unconfirmed)33.57 ± 25.8815.96 ± 14.86
Duration of stable disease26.16 ± 10.6822.52 ± 8.01
SecondaryNumber of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy

A treatment-emergent adverse event (TEAE) was 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. An adverse event that occurs more than 30 days after the last dose of study medication is not included as a TEAE unless it is considered related to treatment. If relationship is missing, the AE is also considered to be related to the drug.

Time frame:
Baseline up to 30 days after last study dose, up to 3 years 3 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events Related to Study Drug With an Incidence of ≥5% Following Use of CS-7017 Or Placebo in Colorectal Cancer Participants Who Have Achieved Disease Control Following First-Line Chemotherapy
ParticipantsCS-7017 0.5 mgPlacebo
Any Related TEAE3716
Any Blood and Lymphatic System Disorder70
Anaemia60
Any General Disorder& Administration Site Disorder236
Face oedema41
Fatigue63
Localised oedema30
Oedema30
Oedema peripheral162
Any Gastrointestinal Disorder62
Any Investigations227
Weight increased205
Any Metabolism and Nutrition Disorder63
Fluid retention52
Any Respiratory, Thoracic, & Mediastinal Disorder80
Dyspnoea40
Pleural effusion30
Any Skin and Subcutaneous Tissue Disorder53

Adverse events

Collected over Treatment-emergent adverse events (TEAEs) were collected from baseline up to 30 days after last dose, up to 3 years 3 months in the Safety Analysis Set.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CS-7017 0.5 mg16/41 (39%)6/41 (14.6%)41/41 (100%)
Placebo23/42 (54.8%)5/42 (11.9%)31/42 (73.8%)
Most frequent serious events
Most frequent serious events
EventCS-7017 0.5 mgPlacebo
AnaemiaBlood and lymphatic system disorders3/410/42
Abdominal painGastrointestinal disorders0/412/42
IleusGastrointestinal disorders1/410/42
Generalised oedemaGeneral disorders1/410/42
PurpuraSkin and subcutaneous tissue disorders1/410/42
Gastrointestinal necrosisGastrointestinal disorders0/411/42
Intestinal obstructionGastrointestinal disorders0/411/42
Intra-abdominal haemorrhageGastrointestinal disorders0/411/42
PeritonitisGastrointestinal disorders0/411/42
Most frequent other events
Showing 10 of 23
Most frequent other events
EventCS-7017 0.5 mgPlacebo
Weight increasedInvestigations21/415/42
Oedema peripheralGeneral disorders17/412/42
AnaemiaBlood and lymphatic system disorders15/410/42
FatigueGeneral disorders11/416/42
DyspnoeaRespiratory, thoracic and mediastinal disorders11/410/42
AstheniaGeneral disorders10/412/42
Abdominal painGastrointestinal disorders4/419/42
DiarrhoeaGastrointestinal disorders2/417/42
NauseaGastrointestinal disorders5/415/42
Fluid retentionMetabolism and nutrition disorders5/412/42

Baseline characteristics

The demographics and baseline characteristics were based on the intent-to-treat analysis set.

Age, Continuous
Age, Continuous(years)CS-7017 0.5 mgPlaceboTotal
Mean64.0 ± 7.6960.9 ± 9.7362.4 ± 8.88
Age, Customized
Age, Customized(Participants)CS-7017 0.5 mgPlaceboTotal
<65 years242650
≥65 years171734
Sex: Female, Male
Sex: Female, Male(Participants)CS-7017 0.5 mgPlaceboTotal
Female191938
Male222446
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CS-7017 0.5 mgPlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American022
White404181
More than one race000
Unknown or Not Reported101
08

Study locations

39 sites
  • Fakulti nemocnice Brno
    Brno, 62500, Czechia
  • Fakultni nemocnice Olomouc
    Olomouc, 77520, Czechia
  • Nemocnice Znojmo, p.o., Oddeleni radiacni a klinicke onkologie
    Znojmo, 66902, Czechia
  • Hopitaux civils de colmar
    Colmar, Cedex 68024, France
  • Hopital Edouard Herriot
    Lyon, Cedex 69437, France
  • Service d'Oncologie Medicale
    Rennes, Cedex 35042, France
  • Centre Hospitalier Prive Saint Gregoire
    Saint Grégoire, 35768, France
  • Onkologische Praxis Donauwörth
    Donauwörth, 86609, Germany
  • Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin
    Halle, 06120, Germany
  • Klinikum rechts der Isar
    München, 81675, Germany
  • Institute for Cancer Research and Treatment - IRCC
    Candiolo, Torino 10060, Italy
  • Ospedale San Martino
    Genova, Italy
  • Unita Operativa di Oncologia Medica
    Lecce, Italy
  • Policlinico Santa Maria alle Scotte
    Siena, 53100, Italy
  • Azienda Ospedaliero Universitaria Santa Maria della Misericordia
    Udine, 33100, Italy
  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
    Bialystok, 15-027, Poland
  • Wojewodzki Szpital Specjalistyczny
    Bytom, 41-902, Poland
  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
    Gliwice, 44-101, Poland
  • VESALIUS Sp. z o.o.
    Krakow, 31-108, Poland
  • NZOZ ONKOLOG s.c.
    Warszawa, 01-002, Poland
  • Medical Radiological Research Centre
    Obninsk, Kaluga 249030, Russian Federation
  • Kazan State Medical University
    Kazan, Tatarstan 4200111, Russian Federation
  • Russian Oncology Research Centre n.a. Blokhin, RAMS
    Moscow, 115478, Russian Federation
  • Central Clinical Hospital #1
    Moscow, 125367, Russian Federation
  • NUZ Semashko Central Clinical Hospital
    Moscow, 129128, Russian Federation
  • St-Petersburg State Institution of Public Health
    St Petersburg, 198255, Russian Federation
  • Federal State Institution of Healthcare Clinical Hospital # 122 n.a.L.G Sokolov
    St-Petersburg, 194291, Russian Federation
  • Tula Regional Oncology dispensary
    Tula, 300053, Russian Federation
  • H.Clinic I Provincial de Barcelona
    Barcelona, Villaroel 170, Spain
  • Clinica Universitaria de Navarra
    Pamplona, 31008, Spain
  • Hospital Mútua de Terrassa
    Terrassa (Barcelona), 08221, Spain
  • Volyn regional oncology dispensary
    Lutsk, Volyn, Ukraine
  • Kyiv City Oncology Hospital
    Kiev, 03115, Ukraine
  • Sumy Regional Oncology Center
    Sumy, 40005, Ukraine
  • Mount Vernon Cancer Centre
    Northwood, Middlesex HA6 2RN, United Kingdom
  • Aberdeen Royal Infirmary
    Aberdeen, AB25 2ZN, United Kingdom
  • St.Bartholomew's Hospital
    London, EC1A 7BE, United Kingdom
  • UCLH Cancer Clinical Trials Unit
    London, NW1 2PQ, United Kingdom
  • Christie Hospital
    Manchester, M20 4BX, United Kingdom
09

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00986440
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Sep 30, 2009
Start date
Jul 31, 2009
Primary completion
Oct 29, 2012
Completion
Oct 29, 2012
Results posted
Nov 5, 2020
Last update
Nov 5, 2020

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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