Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006376

Trial Description

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Title

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

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Trial Acronym

ARIEL3

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URL of the Trial

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Brief Summary in Lay Language

Patients enrolled into this study will be stratified into 3 groups based on gene mutations
identified in their tumor tissue. The purpose of this study is to identify which of these
groups of patients will most likely benefit from treatment with rucaparib.

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Brief Summary in Scientific Language

Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate
[ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated
with homologous recombination (HR) DNA repair deficiency (HRD). Clinical data have shown
that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from
treatment with a PARP and that maintenance treatment with a PARP inhibitor following a
response to platinum-based treatment increases PFS in patients with ovarian cancer. While
patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA
mutation also derived significant benefit.

Patients enrolled into this study will be stratified into 3 groups based on gene mutations
identified in their tumor tissue. The purpose of this study is to identify which of these
groups of patients will most likely benefit from treatment with rucaparib. It is
anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients
with HRD associated with a BRCA gene mutation or other HR gene alteration.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006376
  •   2015/04/14
  •   2013/10/17
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01968213  (ClinicalTrials.gov)
  •   CO-338-014  (Clovis Oncology, Inc.)
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Health Condition or Problem studied

  •   Ovarian Cancer
  •   Fallopian Tube Cancer
  •   Peritoneal Cancer
  •   C56 -  Malignant neoplasm of ovary
  •   C78.6 -  Secondary malignant neoplasm of retroperitoneum and peritoneum
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Interventions/Observational Groups

  •   Drug: Rucaparib
  •   Drug: Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
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Primary Outcome

- Disease progression according to RECIST Version 1.1 (v1.1), as assessed by the investigator, or death from any cause (investigator Progression Free Survival or invPFS), in molecularly defined subgroups; time frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years.

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Secondary Outcome

- Disease progression according to RECIST v1.1, as assessed by Independent Radiology Review (IRR), or death from any cause (irrPFS), in molecularly defined subgroups; time frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years.
- Time to a specified decrease in the DSR P subscale of the FOSI-18 patient reported outcome questionnaire; time frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.
- Time to a specified decrease in the total score of the FOSI-18 patient reported outcome questionnaire; time frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.
- Overall Survival (OS); time frame: Continuously for ~5 years after patient enrolls into study.
- Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications; time frame: Continuously for ~3 years after patient enrolls into study.
- Individual model parameter estimates of rucaparib and covariates identification (PK); time frame: Cycle 1 Day 15, and Cycle 2 Day 1, Cycle 2 Day 15, Cycle 4 Day 1, and Cycle 7 Day 1. Study data collection expected to last for ~7 months.

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Countries of Recruitment

  •   United States
  •   Australia
  •   Belgium
  •   Canada
  •   France
  •   Germany
  •   Israel
  •   Italy
  •   New Zealand
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/01/31
  •   540
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary
peritoneal, or fallopian tube cancer.

- Received ≥2 prior platinum-based treatment regimens.

- Received no more than 1 non-platinum regimen.

- Must have had at least a 6-month disease-free period following prior treatment with
platinum-based chemotherapy and achieved a response.

- Have sufficient archival tumor tissue for analysis.

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Exclusion Criteria

- History of prior cancer except for non-melanoma skin cancer, curatively treated solid
tumor (>5 years ago without evidence of recurrence), and synchronous endometrial
cancer (Stage 1A) with ovarian cancer.

- Prior treatment with any PARP inhibitor, including rucaparib. Patients who received
prior iniparib are eligible.

- Untreated or symptomatic central nervous system metastases.

- Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would
interfere with the absorption of rucaparib.

- Required drainage of ascites fluid during end of chemotherapy treatment or after
completion of chemotherapy treatment.

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Addresses

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    • Clovis Oncology, Inc.
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    • Clovis Oncology, Inc.
    • Heidi Giordano 
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    •   [---]*
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  • start of 1:1-Block address public-contact
    • Clovis Oncology Clinical Trial Information 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.