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← Vegzelma: recurrent peritoneal cancer

NCT01968213 · STUDY IN CONTEXT

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Intent-to-treat: All patients randomized

→

secondary · POSTED

To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).

Intent-to-treat: All patients randomized

→

secondary · POSTED

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.

Intent-to-treat: All patients randomized

→

secondary · POSTED

The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.

Intent-to-treat: All patients randomized

→

secondary · POSTED

The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.

Intent-to-treat: All patients randomized

→

secondary · POSTED

Concentration summary statistics

All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT01968213
qol key
qol-0003
source section id
NCT01968213-om-0003
source outcome index
3
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
measure definition
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
time frame
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Intent-to-treat: All patients randomized
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Time to an 8-point Decrease in the Total Score of the FOSI-18

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT01968213
qol key
qol-0004
source section id
NCT01968213-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Time to an 8-point Decrease in the Total Score of the FOSI-18
measure definition
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
time frame
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Intent-to-treat: All patients randomized
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
nct id
NCT01968213
trial label
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0000
    source section id
    NCT01968213-om-0000
    source outcome index
    0
    endpoint
    Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
    endpoint definition
    Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
    time origin
    Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0001
    source section id
    NCT01968213-om-0001
    source outcome index
    1
    endpoint
    Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
    endpoint definition
    To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).
    time origin
    Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0002
    source section id
    NCT01968213-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
    time origin
    All patients were followed for survival up to approximately 8.2 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0003
    source section id
    NCT01968213-om-0003
    source outcome index
    3
    endpoint
    Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
    endpoint definition
    The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
    time origin
    Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0004
    source section id
    NCT01968213-om-0004
    source outcome index
    4
    endpoint
    Time to an 8-point Decrease in the Total Score of the FOSI-18
    endpoint definition
    The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
    time origin
    Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0005
    source section id
    NCT01968213-om-0005
    source outcome index
    5
    endpoint
    Individual Model Parameter Estimates of Rucaparib and Covariates Identification
    endpoint definition
    Concentration summary statistics
    time origin
    Study data collection occurred over approximately 7 months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    375
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    375
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    375
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    375
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    375
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    189
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Rucaparib 600 mg Tablets
    regimen
    Taken orally twice daily (continuous 28 day treatment cycles)
    analyzed count
    295
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01968213-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    harm key
    EG000
    source section id
    NCT01968213-ae
    event group key
    EG000
    event group label
    Rucaparib 600 mg Tablets
    serious affected
    91
    serious at risk
    372
    other affected
    372
    other at risk
    372
    frequency threshold
    5
    collection period
    Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years.
    event definition
    Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    harm key
    EG001
    source section id
    NCT01968213-ae
    event group key
    EG001
    event group label
    Placebo Tablets
    serious affected
    20
    serious at risk
    189
    other affected
    182
    other at risk
    189
    frequency threshold
    5
    collection period
    Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years.
    event definition
    Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    qol key
    qol-0003
    source section id
    NCT01968213-om-0003
    source outcome index
    3
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
    measure definition
    The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
    time frame
    Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-malignant-peritoneal-neoplasm-vegzelma-2693c549
    nct id
    NCT01968213
    qol key
    qol-0004
    source section id
    NCT01968213-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact' in the study's own wording
    scale title
    Time to an 8-point Decrease in the Total Score of the FOSI-18
    measure definition
    The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
    time frame
    Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Intent-to-treat: All patients randomized
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice