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CompletedNCT01936363Updated Dec 12, 2018Results posted

Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

A Phase 2 interventional study of Pimasertib once daily and Pimasertib placebo in Ovarian Cancer, sponsored by EMD Serono. Completed at 34 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by EMD Serono · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

02

Conditions studied

  • Ovarian Cancer

Keywords

  • Ovarian Cancer
  • Pimasertib
  • Placebo
  • SAR245409
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 65 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • The female participant had a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tumor, ovarian or peritoneal tumor of low-malignant potential, ovarian or peritoneal atypical proliferative serous tumor that recurs as low grade serous carcinoma or has invasive peritoneal implants
  • The participant had at least one prior line of systemic therapy and had a tumor, which was not amenable to potentially curative surgical resection
  • The participant had measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • The participant had read and understood the written informed consent form (ICF) and was willing and able to gave informed consent, fully understood the requirements of the trial and was willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities
  • Women of childbearing potential must had a negative serum pregnancy test at the screening visit
  • Women of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and at least 3 months after the last dose of trial medication
  • Other protocol defined inclusion criteria may apply

Exclusion criteria

Exclusion Criteria:

  • The participant had previously been treated with a PI3K inhibitor and taken off treatment due to treatment related AEs
  • The participant had been previously treated with a Mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor
  • Any anti-cancer therapy or treatment incorporating chemotherapy, immunotherapy, hormonal therapy, or biologic therapy within 28 days of the start of trial treatment or within 5 times the half-life of such treatment, whichever was shorter. Treatment with nitrosoureas or mitomycin C were exceptions to this for which a treatment interval of at least 6 weeks was required
  • The participant had not recovered from toxicity due to prior therapy to baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (\<=) 2 was permitted
  • The participant had poor organ and marrow function as defined in the protocol
  • The participant had creatine phosphokinase (CPK) elevation NCI CTCAE grade greater than equal to (>=) 2, and/or a previous history of myositis or rhabdomyolysis
  • The participant had difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the trial drug. Participants requiring total parenteral nutrition were to be excluded
  • The participant had a history of delayed healing/open wounds or diabetic ulcers
  • The participant had a history of congestive heart failure, unstable angina, myocardial infarction, cardiac conduction abnormalities including Fridericia corrected QT interval (QTcF) prolongation of > 480 milliseconds (ms) or a pacemaker, clinically relevant impaired cardiovascular function (New York Heart Association (NYHA) class III/IV) or stroke within 3 months prior to enrollment
  • The participant had a history of retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), uveitis or retinal vein occlusion (RVO), or had other relevant abnormalities identified on screening ophthalmologic examination, which might increase the risk of serous retinal detachment (SRD) or RVO
  • The participant had a history of uncontrolled intercurrent illness including but not limited to an active infection, hypertension, or uncontrolled diabetes (e.g. glycosylated hemoglobin >= 8 percent [%]) that would limit compliance with treatment requirements
  • Any previous malignancy treated with curative intent and the participant had been disease free for less than 5 years prior to randomization, with exception of carcinoma-in-situ of the cervix, squamous carcinoma of the skin, basal cell carcinoma of the skin
  • Other protocol defined exclusion criteria may apply
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Pimasertib (once daily) plus SAR245409

    Drug: Pimasertib once daily · Drug: Pimasertib placebo · Drug: SAR245409

  • Experimental
    Pimasertib (twice daily) plus SAR245409 placebo

    Drug: SAR245409 placebo · Drug: Pimasertib twice daily

Interventions

  • DrugPimasertib once daily

    Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

  • DrugPimasertib placebo

    Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

  • DrugSAR245409 placebo

    Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

  • DrugSAR245409

    SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

  • DrugPimasertib twice daily

    Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.

06

What researchers measure

Primary outcomes

  1. Objective Tumor Response

    Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (\<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Time frame: From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months

Secondary outcomes

  1. Progression-Free Survival

    PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley.

    Time frame: Time from randomization until first observation of progressive disease or death, assessed up to 52 months

  2. Percentage of Participants With Disease Control

    Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

    Time frame: Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months

  3. Overall Survival

    Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants.

    Time frame: Time from randomization until death, assessed up to 52 months

  4. Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

    EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Time frame: Baseline up to disease progression or withdrawal, assessed up to 52 months

  5. Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)

    EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life.

    Time frame: Baseline up to disease progression or withdrawal, assessed up to 52 months

  6. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death

    TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state.

    Time frame: First dose of study drug up to 52 months

  7. Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409

    Time frame: Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43

  8. Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409

    Time frame: Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43

  9. Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood

    Time frame: Screening visit (day -28 to 1)

07

Results

Posted Apr 7, 2017

Participant flow

First/last participants (informed consent): Sep 2013/Oct 2014. Clinical data cut off: Jan 2018.

Participant flow — Overall Study
MilestonePimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
Started3233
Completed3233
Not completed00

Outcome measures

PrimaryObjective Tumor Response

Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (\<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:
From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months
Reported as:
Number · percentage of participants
Objective Tumor Response
percentage of participantsPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
Objective Tumor Response12.5 (3.5 to 29.0)12.1 (3.4 to 28.2)
SecondaryProgression-Free Survival

PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley.

Time frame:
Time from randomization until first observation of progressive disease or death, assessed up to 52 months
Reported as:
Median · months
Progression-Free Survival
monthsPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
Progression-Free Survival9.99 (3.42 to 15.21)12.71 (4.21 to NA)
SecondaryPercentage of Participants With Disease Control

Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Time frame:
Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Control
percentage of participantsPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
Percentage of Participants With Disease Control50.0 (31.9 to 68.1)39.4 (22.9 to 57.9)
SecondaryOverall Survival

Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants.

Time frame:
Time from randomization until death, assessed up to 52 months
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
Number of deaths86
Number for censored2427
SecondaryHealth Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)

EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

Time frame:
Baseline up to disease progression or withdrawal, assessed up to 52 months

No measurements were reported for this outcome.

SecondaryHealth Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)

EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life.

Time frame:
Baseline up to disease progression or withdrawal, assessed up to 52 months

No measurements were reported for this outcome.

SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death

TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state.

Time frame:
First dose of study drug up to 52 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death
ParticipantsPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
TEAE3232
Serious TEAE1618
TEAE leading to discontinuation of study treatment1612
Death23
SecondaryMaximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409
Time frame:
Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43

No measurements were reported for this outcome.

SecondaryArea Under the Curve (AUC) After Dose of Pimasertib and SAR245409
Time frame:
Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43

No measurements were reported for this outcome.

SecondaryMolecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood
Time frame:
Screening visit (day -28 to 1)

No measurements were reported for this outcome.

Adverse events

Collected over First dose of study drug up to 52 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pimasertib (Once Daily) Plus SAR245409—16/32 (50%)32/32 (100%)
Pimasertib (Twice Daily) Plus SAR245409 Placebo—18/32 (56.3%)32/32 (100%)
Most frequent serious events
Showing 10 of 67
Most frequent serious events
EventPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
DiarrhoeaGastrointestinal disorders1/324/32
PyrexiaGeneral disorders3/322/32
DehydrationMetabolism and nutrition disorders0/323/32
NauseaGastrointestinal disorders2/322/32
Intestinal obstructionGastrointestinal disorders1/322/32
Small intestinal obstructionGastrointestinal disorders2/322/32
AscitesGastrointestinal disorders0/322/32
VomitingGastrointestinal disorders2/320/32
Blood creatine phosphokinase increasedInvestigations2/321/32
DyspnoeaRespiratory, thoracic and mediastinal disorders0/322/32
Most frequent other events
Showing 10 of 104
Most frequent other events
EventPimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 Placebo
DiarrhoeaGastrointestinal disorders26/3226/32
NauseaGastrointestinal disorders22/3213/32
FatigueGeneral disorders19/3214/32
Blood creatine phosphokinase increasedInvestigations19/3219/32
Dermatitis acneiformSkin and subcutaneous tissue disorders12/3219/32
Vision blurredEye disorders16/3211/32
VomitingGastrointestinal disorders16/3214/32
Oedema peripheralGeneral disorders11/3215/32
StomatitisGastrointestinal disorders13/329/32
AlopeciaSkin and subcutaneous tissue disorders12/324/32

Baseline characteristics

Intent-to Treat (ITT) analysis set included all participant who were randomized.

Age, Continuous
Age, Continuous(years)Pimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 PlaceboTotal
Mean47.3 ± 14.0750.6 ± 16.3949.0 ± 15.26
Sex: Female, Male
Sex: Female, Male(Participants)Pimasertib (Once Daily) Plus SAR245409Pimasertib (Twice Daily) Plus SAR245409 PlaceboTotal
Female323365
Male000
08

Study locations

34 sites
  • Research site
    Augusta, Georgia 30912, United States
  • Research site
    Chicago, Illinois 60637, United States
  • Research site
    Indianapolis, Indiana 46202, United States
  • Research site
    Silver Spring, Maryland 20910, United States
  • Research site
    Boston, Massachusetts 02114, United States
  • Research site
    Boston, Massachusetts 02215-5450, United States
  • Research site
    Ann Arbor, Michigan 48109, United States
  • Research site
    Detroit, Michigan 48202, United States
  • Research site
    Kansas City, Missouri 64111, United States
  • Research site
    Saint Louis, Missouri 63110, United States
  • Research site
    Kalispell, Montana 59901, United States
  • Research site
    New York, New York 10065, United States
  • Research site
    Cincinnati, Ohio 45219, United States
  • Research site
    Columbus, Ohio 43210, United States
  • Research site
    Middletown, Ohio 45042, United States
  • Research site
    Nashville, Tennessee 37203, United States
  • Research site
    Houston, Texas 77030, United States
  • Research site
    Northmead, New South Wales 2152, Australia
  • Research site
    Greenslopes, Queensland 4120, Australia
  • Research site
    Subiaco, Western Australia 6008, Australia
  • Research site
    Kortrijk, 8500, Belgium
  • Research site
    Leuven, 3000, Belgium
  • Research site
    Hamilton, Ontario L8V 5C2, Canada
  • Research site
    Toronto, Ontario M4N 3M5, Canada
  • Research site
    Montreal, Quebec H2L 4M1, Canada
  • Research site
    Montreal, Quebec H2W 1S6, Canada
  • Research site
    Quebec, G1R 2J6, Canada
  • Research site
    Bordeaux Cedex, Gironde 33076, France
  • Research site
    Chorzow, 41-500, Poland
  • Research site
    Palma Mallorca, Baleares 07198, Spain
  • Research site
    Madrid, 28033, Spain
  • Research site
    Madrid, 28046, Spain
  • Research site
    Sevilla, 41013, Spain
  • Research site
    Valencia, 46010, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01936363
Lead sponsor
EMD Serono
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 6, 2013
Start date
Sep 30, 2013
Primary completion
May 31, 2015
Completion
Nov 30, 2017
Results posted
Apr 7, 2017
Last update
Dec 12, 2018

Study contacts

Medical Responsible
study director · Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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