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A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT00804908
Collaborator
(none)
346
Enrollment
3
Arms
83
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
346 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo for ABT-888 BID + TMZ QD

Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

Drug: temozolomide
temozolomide capsule administered orally once daily for 5 days every 28 days
Other Names:
  • Temodar
  • Temodal

    • Other: Placebo
    Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days
    Active Comparator: ABT-888 20 mg BID + TMZ QD

    ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

    Drug: temozolomide
    temozolomide capsule administered orally once daily for 5 days every 28 days
    Other Names:
  • Temodar
  • Temodal

    • Drug: ABT-888
    ABT-888 capsule administered orally twice daily for 7 days every 28 days
    Other Names:
  • veliparib

    		•
    Active Comparator: ABT-888 40 mg BID + TMZ QD

    ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

    Drug: temozolomide
    temozolomide capsule administered orally once daily for 5 days every 28 days
    Other Names:
  • Temodar
  • Temodal

    • Drug: ABT-888
    ABT-888 capsule administered orally twice daily for 7 days every 28 days
    Other Names:
  • veliparib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS): Time to Event [Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.]

      PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.

    Secondary Outcome Measures

    1. Overall Survival (OS): Time to Event [Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.]

      OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints.

    2. 12-Month Overall Survival (OS) Rate [Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.]

      The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    3. 6-month Progression-Free Survival Rate [Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.]

      The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    4. Objective Response Rate [Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.]

      The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    5. Time to Disease Progression [Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.]

      The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    6. Disease Control Rate [Week 8]

      The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    7. Time to Neurological/Brain Metastases Progression [Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.]

      Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.

    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 metastatic melanoma.

    • Unresectable Stage III or Stage IV metastatic melanoma.

    • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

    • Subjects with no history of brain metastases demonstrated by a baseline MRI, or subjects with a history of previously treated brain metastases who have history of operable/SRS treatable brain metastases and completed surgical resection/stereotactic radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to Day 1; have baseline MRI that shows no evidence of active intercranial disease; have discontinued taking medications for symptom management of brain metastases at least 7 days prior to Day 1

    • 28 days since prior anti-cancer therapy.

    • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.

    • Adequate hematologic, renal and hepatic function.

    • Partial Thromboplastin Time (PTT) is <= 1.5 x upper normal limit of institution's normal range and international normalized ratio (INR) < 1.5.

    • Subject's with significant fluid retention may be allowed at the discretion of the investigator.

    • Life expectancy > 12 weeks.

    • Females must not be pregnant.

    • Voluntarily signed informed consent.

    Exclusion Criteria:

    • Lactate Dehydrogenase (LDH) > 2 x Upper Limit of Normal (ULN).

    • Ocular malignant melanoma.

    • History of central nervous system metastases or leptomeningeal disease.

    • Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).

    • Prior DNA damaging agents or cytotoxic chemotherapy.

    • Prior Whole Brain Radiation Therapy (with exceptions).

    • Received an investigational agent within 28 days of study.

    • History of seizure disorder and/or taking medication for seizure disorder.

    • Active malignancy within the past 5 years, except cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

    • Medical condition that would cause a high risk for toxicities.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: AbbVie Inc, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT00804908
    Other Study ID Numbers:
    • M10-440
    • 2008-004941-27
    First Posted:
    Dec 9, 2008
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    Mar 1, 2017
    Keywords provided by AbbVie (prior sponsor, Abbott)
    Temozolomide
    Skin cancer
    Melanoma
    Metastatic Melanoma
    ABT-888
    MM
    Additional relevant MeSH terms:
    Melanoma
    Skin Neoplasms
    Temozolomide
    Veliparib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail A total of 346 subjects were randomized; 2 subjects did not receive study drug and were excluded from the safety analysis.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Period Title: Overall Study
    STARTED 115 116 115
    COMPLETED 0 0 1
    NOT COMPLETED 115 116 114

    Baseline Characteristics

    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD Total
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. Total of all reporting groups
    Overall Participants 115 116 115 346
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.4
    (14.13)
    58.6
    (12.55)
    62.3
    (13.50)
    59.8
    (13.49)
    Sex: Female, Male (Count of Participants)
    Female
    36
    31.3%
    45
    38.8%
    38
    33%
    119
    34.4%
    Male
    79
    68.7%
    71
    61.2%
    77
    67%
    227
    65.6%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS): Time to Event
    Description PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.
    Time Frame Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    25th Percentile
    54
    56
    53
    50th Percentile
    60
    113
    110
    75th Percentile
    163
    225
    226
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo for ABT-888 BID + TMZ QD, ABT-888 20 mg BID + TMZ QD
    Comments Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; >1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value =0.071
    Comments
    Method Stratified log-rank
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo for ABT-888 BID + TMZ QD, ABT-888 40 mg BID + TMZ QD
    Comments Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; >1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value =0.233
    Comments
    Method Stratified log-rank
    Comments
    2. Secondary Outcome
    Title Overall Survival (OS): Time to Event
    Description OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints.
    Time Frame Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    25th Percentile
    207
    204
    181
    50th percentile
    390
    327
    412
    75th percentile
    559
    NA
    NA
    3. Secondary Outcome
    Title 12-Month Overall Survival (OS) Rate
    Description The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    Number (95% Confidence Interval) [percentage of participants]
    52.6
    45.7%
    43.5
    37.5%
    54.1
    47%
    4. Secondary Outcome
    Title 6-month Progression-Free Survival Rate
    Description The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    Number (95% Confidence Interval) [percentage of participants]
    19.1
    16.6%
    32.8
    28.3%
    30.7
    26.7%
    5. Secondary Outcome
    Title Objective Response Rate
    Description The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.

    Outcome Measure Data

    Analysis Population Description
    All subjects in the ITT population (defined as all randomized participants) with measurable disease.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    Number (95% Confidence Interval) [percentage of participants]
    7.0
    6.1%
    10.3
    8.9%
    9.6
    8.3%
    6. Secondary Outcome
    Title Time to Disease Progression
    Description The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    25th Percentile
    54
    56
    53
    50th percentile
    60
    113
    110
    75th percentile
    163
    225
    226
    7. Secondary Outcome
    Title Disease Control Rate
    Description The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Week 8

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    Number (95% Confidence Interval) [percentage of participants]
    48.7
    42.3%
    62.9
    54.2%
    59.1
    51.4%
    8. Secondary Outcome
    Title Time to Neurological/Brain Metastases Progression
    Description Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values.
    Time Frame Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months.

    Outcome Measure Data

    Analysis Population Description
    ITT population defined as all randomized participants.
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    Measure Participants 115 116 115
    25th Percentile
    60
    119
    184
    50th percentile
    NA
    NA
    184
    75th percentile
    NA
    NA
    NA

    Adverse Events

    Time Frame Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 5.6 years); SAEs were collected from the time informed consent was obtained (up to 5.7 years).
    Adverse Event Reporting Description
    Arm/Group Title Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Arm/Group Description Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
    All Cause Mortality
    Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 28/113 (24.8%) 27/116 (23.3%) 31/115 (27%)
    Blood and lymphatic system disorders
    ANAEMIA 2/113 (1.8%) 0/116 (0%) 3/115 (2.6%)
    BONE MARROW FAILURE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    FEBRILE NEUTROPENIA 0/113 (0%) 2/116 (1.7%) 0/115 (0%)
    LEUKOPENIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    LYMPHADENOPATHY 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    NEUTROPENIA 1/113 (0.9%) 0/116 (0%) 3/115 (2.6%)
    PANCYTOPENIA 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    THROMBOCYTOPENIA 4/113 (3.5%) 3/116 (2.6%) 4/115 (3.5%)
    Cardiac disorders
    ANGINA PECTORIS 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    ARRHYTHMIA 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    CARDIAC FAILURE CONGESTIVE 0/113 (0%) 2/116 (1.7%) 0/115 (0%)
    PERICARDIAL EFFUSION 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Endocrine disorders
    ADRENAL INSUFFICIENCY 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 1/113 (0.9%) 1/116 (0.9%) 0/115 (0%)
    CONSTIPATION 1/113 (0.9%) 1/116 (0.9%) 0/115 (0%)
    GASTRIC HAEMORRHAGE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    GASTROINTESTINAL HAEMORRHAGE 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    HAEMATOCHEZIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    INTESTINAL OBSTRUCTION 0/113 (0%) 1/116 (0.9%) 1/115 (0.9%)
    MELAENA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    MOUTH SWELLING 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    NAUSEA 2/113 (1.8%) 1/116 (0.9%) 1/115 (0.9%)
    SMALL INTESTINAL HAEMORRHAGE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    SMALL INTESTINAL OBSTRUCTION 1/113 (0.9%) 1/116 (0.9%) 0/115 (0%)
    UPPER GASTROINTESTINAL HAEMORRHAGE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    VOMITING 2/113 (1.8%) 2/116 (1.7%) 1/115 (0.9%)
    General disorders
    DEATH 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    DISEASE PROGRESSION 2/113 (1.8%) 0/116 (0%) 1/115 (0.9%)
    FATIGUE 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    PAIN 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    PYREXIA 1/113 (0.9%) 1/116 (0.9%) 1/115 (0.9%)
    Hepatobiliary disorders
    CHOLANGITIS 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    CHOLECYSTITIS ACUTE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Infections and infestations
    APPENDICITIS 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    BRONCHITIS 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    CELLULITIS 1/113 (0.9%) 1/116 (0.9%) 0/115 (0%)
    LOCALISED INFECTION 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    LOWER RESPIRATORY TRACT INFECTION 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    PNEUMONIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    POST PROCEDURAL INFECTION 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    SEPSIS 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Injury, poisoning and procedural complications
    ALLERGIC TRANSFUSION REACTION 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    ANKLE FRACTURE 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    FACIAL BONES FRACTURE 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    LIMB CRUSHING INJURY 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    RADIUS FRACTURE 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    Investigations
    HAEMOGLOBIN DECREASED 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    DEHYDRATION 2/113 (1.8%) 1/116 (0.9%) 2/115 (1.7%)
    HYPERCALCAEMIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    Musculoskeletal and connective tissue disorders
    BACK PAIN 0/113 (0%) 2/116 (1.7%) 1/115 (0.9%)
    MUSCULOSKELETAL CHEST PAIN 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    NECK PAIN 0/113 (0%) 1/116 (0.9%) 1/115 (0.9%)
    PATHOLOGICAL FRACTURE 1/113 (0.9%) 0/116 (0%) 1/115 (0.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CANCER PAIN 2/113 (1.8%) 1/116 (0.9%) 2/115 (1.7%)
    GLIOSARCOMA 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    MALIGNANT MELANOMA 2/113 (1.8%) 0/116 (0%) 0/115 (0%)
    MALIGNANT NEOPLASM PROGRESSION 1/113 (0.9%) 1/116 (0.9%) 1/115 (0.9%)
    MALIGNANT PLEURAL EFFUSION 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    METASTASES TO BONE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    METASTATIC MALIGNANT MELANOMA 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    METASTATIC PAIN 0/113 (0%) 1/116 (0.9%) 1/115 (0.9%)
    OESOPHAGEAL ADENOCARCINOMA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    Nervous system disorders
    APHASIA 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    ATAXIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    CEREBROVASCULAR ACCIDENT 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    DIZZINESS 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    HAEMORRHAGE INTRACRANIAL 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    NEUROPATHY PERIPHERAL 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    SPINAL CORD COMPRESSION 1/113 (0.9%) 0/116 (0%) 1/115 (0.9%)
    SYNCOPE 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    TREMOR 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Psychiatric disorders
    ANXIETY 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    CONFUSIONAL STATE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    Renal and urinary disorders
    HAEMATURIA 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    NEPHROLITHIASIS 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    RENAL FAILURE ACUTE 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    URETHRAL PROLAPSE 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    HAEMOTHORAX 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    PLEURAL EFFUSION 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    PULMONARY ARTERY THROMBOSIS 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    PULMONARY EMBOLISM 0/113 (0%) 0/116 (0%) 4/115 (3.5%)
    PULMONARY THROMBOSIS 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    Vascular disorders
    DEEP VEIN THROMBOSIS 0/113 (0%) 0/116 (0%) 1/115 (0.9%)
    HYPOTENSION 0/113 (0%) 1/116 (0.9%) 0/115 (0%)
    ORTHOSTATIC HYPOTENSION 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    PELVIC VENOUS THROMBOSIS 1/113 (0.9%) 0/116 (0%) 0/115 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo for ABT-888 BID + TMZ QD ABT-888 20 mg BID + TMZ QD ABT-888 40 mg BID + TMZ QD
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 112/113 (99.1%) 116/116 (100%) 113/115 (98.3%)
    Blood and lymphatic system disorders
    ANAEMIA 9/113 (8%) 19/116 (16.4%) 13/115 (11.3%)
    LEUKOPENIA 5/113 (4.4%) 8/116 (6.9%) 8/115 (7%)
    LYMPHOPENIA 5/113 (4.4%) 4/116 (3.4%) 6/115 (5.2%)
    NEUTROPENIA 7/113 (6.2%) 24/116 (20.7%) 26/115 (22.6%)
    THROMBOCYTOPENIA 19/113 (16.8%) 49/116 (42.2%) 56/115 (48.7%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 8/113 (7.1%) 11/116 (9.5%) 15/115 (13%)
    ABDOMINAL PAIN UPPER 3/113 (2.7%) 4/116 (3.4%) 6/115 (5.2%)
    CONSTIPATION 62/113 (54.9%) 60/116 (51.7%) 62/115 (53.9%)
    DIARRHOEA 24/113 (21.2%) 27/116 (23.3%) 26/115 (22.6%)
    DRY MOUTH 6/113 (5.3%) 3/116 (2.6%) 0/115 (0%)
    DYSPEPSIA 12/113 (10.6%) 8/116 (6.9%) 8/115 (7%)
    GASTROOESOPHAGEAL REFLUX DISEASE 0/113 (0%) 10/116 (8.6%) 2/115 (1.7%)
    NAUSEA 75/113 (66.4%) 83/116 (71.6%) 82/115 (71.3%)
    VOMITING 53/113 (46.9%) 42/116 (36.2%) 30/115 (26.1%)
    General disorders
    CHEST PAIN 4/113 (3.5%) 5/116 (4.3%) 6/115 (5.2%)
    CHILLS 4/113 (3.5%) 8/116 (6.9%) 8/115 (7%)
    FATIGUE 73/113 (64.6%) 75/116 (64.7%) 77/115 (67%)
    INFLUENZA LIKE ILLNESS 4/113 (3.5%) 6/116 (5.2%) 1/115 (0.9%)
    OEDEMA PERIPHERAL 1/113 (0.9%) 9/116 (7.8%) 4/115 (3.5%)
    PAIN 8/113 (7.1%) 10/116 (8.6%) 12/115 (10.4%)
    PYREXIA 6/113 (5.3%) 7/116 (6%) 4/115 (3.5%)
    Infections and infestations
    SINUSITIS 5/113 (4.4%) 7/116 (6%) 3/115 (2.6%)
    UPPER RESPIRATORY TRACT INFECTION 7/113 (6.2%) 8/116 (6.9%) 10/115 (8.7%)
    Investigations
    HAEMOGLOBIN DECREASED 6/113 (5.3%) 3/116 (2.6%) 3/115 (2.6%)
    PLATELET COUNT DECREASED 4/113 (3.5%) 12/116 (10.3%) 10/115 (8.7%)
    WEIGHT DECREASED 7/113 (6.2%) 7/116 (6%) 6/115 (5.2%)
    Metabolism and nutrition disorders
    DECREASED APPETITE 37/113 (32.7%) 26/116 (22.4%) 36/115 (31.3%)
    HYPERGLYCAEMIA 6/113 (5.3%) 4/116 (3.4%) 5/115 (4.3%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 13/113 (11.5%) 17/116 (14.7%) 14/115 (12.2%)
    BACK PAIN 10/113 (8.8%) 21/116 (18.1%) 14/115 (12.2%)
    GROIN PAIN 3/113 (2.7%) 4/116 (3.4%) 6/115 (5.2%)
    MUSCLE SPASMS 1/113 (0.9%) 2/116 (1.7%) 6/115 (5.2%)
    MUSCULOSKELETAL CHEST PAIN 6/113 (5.3%) 7/116 (6%) 1/115 (0.9%)
    MUSCULOSKELETAL PAIN 11/113 (9.7%) 11/116 (9.5%) 9/115 (7.8%)
    MYALGIA 7/113 (6.2%) 4/116 (3.4%) 8/115 (7%)
    PAIN IN EXTREMITY 11/113 (9.7%) 13/116 (11.2%) 10/115 (8.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CANCER PAIN 6/113 (5.3%) 0/116 (0%) 0/115 (0%)
    TUMOUR PAIN 1/113 (0.9%) 3/116 (2.6%) 6/115 (5.2%)
    Nervous system disorders
    DIZZINESS 17/113 (15%) 19/116 (16.4%) 15/115 (13%)
    DYSGEUSIA 8/113 (7.1%) 15/116 (12.9%) 11/115 (9.6%)
    HEADACHE 30/113 (26.5%) 22/116 (19%) 25/115 (21.7%)
    LETHARGY 7/113 (6.2%) 6/116 (5.2%) 6/115 (5.2%)
    Psychiatric disorders
    ANXIETY 7/113 (6.2%) 6/116 (5.2%) 5/115 (4.3%)
    INSOMNIA 12/113 (10.6%) 12/116 (10.3%) 14/115 (12.2%)
    Respiratory, thoracic and mediastinal disorders
    COUGH 16/113 (14.2%) 28/116 (24.1%) 18/115 (15.7%)
    DYSPNOEA 11/113 (9.7%) 17/116 (14.7%) 17/115 (14.8%)
    EPISTAXIS 5/113 (4.4%) 1/116 (0.9%) 10/115 (8.7%)
    OROPHARYNGEAL PAIN 6/113 (5.3%) 7/116 (6%) 5/115 (4.3%)
    Skin and subcutaneous tissue disorders
    DRY SKIN 5/113 (4.4%) 2/116 (1.7%) 8/115 (7%)
    ERYTHEMA 2/113 (1.8%) 7/116 (6%) 3/115 (2.6%)
    HYPERHIDROSIS 6/113 (5.3%) 3/116 (2.6%) 2/115 (1.7%)
    NIGHT SWEATS 7/113 (6.2%) 7/116 (6%) 3/115 (2.6%)
    PRURITUS 15/113 (13.3%) 7/116 (6%) 6/115 (5.2%)
    RASH 6/113 (5.3%) 10/116 (8.6%) 11/115 (9.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Information
    Organization AbbVie
    Phone 800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT00804908
    Other Study ID Numbers:
    • M10-440
    • 2008-004941-27
    First Posted:
    Dec 9, 2008
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    Mar 1, 2017