ROSY-O: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

Sponsor
AstraZeneca (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04421963
Collaborator
(none)
153
Enrollment
90
Locations
1
Arm
57.3
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The rationale of the ROSY-O study is to continue to provide study treatment for patients who have participated in a parent study with olaparib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

ROSY-O is an open label, non-randomised, multicentre,international trial for patients who have completed a parent study using olaparib and who are deriving clinical benefit from continued treatment as judged by the Investigator. Patients will be rolled-over from the parent study and will continue the study indefinitely, until they meet one of the treatment discontinuation criteria

Study Design

Study Type:
Interventional
Anticipated Enrollment :
153 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
Actual Study Start Date :
Aug 4, 2020
Anticipated Primary Completion Date :
May 13, 2025
Anticipated Study Completion Date :
May 13, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Olaparib

Treatment

Drug: Olaparib
300 mg olaparib (2×150 mg tablets) twice daily

Outcome Measures

Primary Outcome Measures

  1. Safety follow up [Baseline up to approximately 10 years]

    Serious adverse events and adverse events of special interest reported until 30 days after the last dose of study drug.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Provision of signed and dated, written ICF.

  2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.

  3. Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.

Exclusion Criteria:
  1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.

  2. Currently receiving treatment with any prohibited medication(s).

  3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

  4. Permanent discontinuation from the parent study due to toxicity or disease progression.

  5. Local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Research SiteShreveportLouisianaUnited States71103
2Research SiteDetroitMichiganUnited States48201
3Research SiteMinneapolisMinnesotaUnited States55407
4Research SiteBasking RidgeNew JerseyUnited States07920
5Research SiteHackensackNew JerseyUnited States07601
6Research SiteBronxNew YorkUnited States10461
7Research SiteNew YorkNew YorkUnited States10032
8Research SitePhiladelphiaPennsylvaniaUnited States19104
9Research SitePittsburghPennsylvaniaUnited States15224
10Research SiteWillow GrovePennsylvaniaUnited States19090
11Research SiteProvidenceRhode IslandUnited States02905
12Research SiteGermantownTennesseeUnited States38138
13Research SiteHoustonTexasUnited States77030
14Research SiteLeuvenBelgium3000
15Research SiteNamurBelgium5000
16Research SitePlovdivBulgaria4000
17Research SitePlovdivBulgaria4004
18Research SiteSofiaBulgaria1330
19Research SiteHalifaxNova ScotiaCanadaB3H 1V7
20Research SiteKingstonOntarioCanadaK7L 2V7
21Research SiteMississaugaOntarioCanadaL5M 2N1
22Research SiteTorontoOntarioCanadaM4N 3M5
23Research SiteTorontoOntarioCanadaM5G 2M9
24Research SiteMontrealQuebecCanadaH1T 2M4
25Research SiteMontrealQuebecCanadaH2X 0A9
26Research SiteMontrealQuebecCanadaH3T 1E2
27Research SiteMontrealQuebecCanadaH4A-3J1
28Research SiteQuebec CityQuebecCanadaG1S 4L8
29Research SiteBrnoCzechia625 00
30Research SiteBrnoCzechia656 53
31Research SiteOlomoucCzechia779 00
32Research SiteOstrava PorubaCzechia708 52
33Research SitePraha 2Czechia128 08
34Research SitePraha 5Czechia150 06
35Research SiteAalborgDenmark9000
36Research SiteKuopioFinland70210
37Research SiteLyonFrance69373
38Research SitePlerinFrance22190
39Research SiteDresdenGermany1307
40Research SiteEssenGermany45136
41Research SiteFrankfurtGermany60590
42Research SiteBudapestHungary1032
43Research SiteBudapestHungary1122
44Research SiteRamat GanIsrael5265601
45Research SiteAnconaItaly60020
46Research SiteBolognaItaly40138
47Research SiteBresciaItaly25123
48Research SiteCandioloItaly10060
49Research SiteCataniaItaly95126
50Research SiteLecceItaly73100
51Research SiteMilanoItaly20132
52Research SiteMilanoItaly20133
53Research SiteMilanItaly20141
54Research SiteNapoliItaly80131
55Research SitePadovaItaly35128
56Research SiteRomaItaly00168
57Research SiteTorinoItaly10126
58Research SiteTorinoItaly10128
59Research SiteSeoulKorea, Republic of03722
60Research SiteSeoulKorea, Republic of6351
61Research SiteBiałystokPoland15-027
62Research SiteGrzepnicaPoland72-003
63Research SitePoznańPoland60-569
64Research SitePortoPortugal4200-072
65Research SiteSankt-PeterburgRussian Federation197758
66Research SiteLjubljanaSlovenia1000
67Research SiteBarcelonaSpain08035
68Research SiteBarcelonaSpain08036
69Research SiteBarcelonaSpain08916
70Research SiteBarcelonaSpain8907
71Research SiteBarcelonaSpain?08041
72Research SiteCordobaSpain14004
73Research SiteGranadaSpain18014
74Research SiteMadridSpain28027
75Research SiteMadridSpain28041
76Research SiteMadridSpain28046
77Research SitePamplonaSpain31008
78Research SiteValenciaSpain46026
79Research SiteVigoSpain36312
80Research SiteZaragozaSpain50009
81Research SiteLundSweden221 85
82Research SiteAnkaraTurkey06230
83Research SiteIstanbulTurkey34093
84Research SiteEdinburghUnited KingdomEH4 2XU
85Research SiteGlasgowUnited KingdomG12 OYN
86Research SiteLondonUnited KingdomSE1 7EH
87Research SiteLondonUnited KingdomSW3 6JJ
88Research SiteManchesterUnited KingdomM20 4BX
89Research SiteScarboroughUnited KingdomYO12 6QL
90Research SiteTauntonUnited KingdomTA1 5DA

Sponsors and Collaborators

  • AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT04421963
Other Study ID Numbers:
  • D0817C00098
  • 2019-003777-26
First Posted:
Jun 9, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AstraZeneca
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021