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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
99
Locations
1
Arm
52.5
Anticipated Duration (Months)
1.5
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 Disease Intervention/Treatment Phase
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 :
Dec 19, 2024
Anticipated Study Completion Date :
Dec 19, 2024

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Research Site Boca Raton Florida United States 33486
2 Research Site Towson Maryland United States 21204
3 Research Site Detroit Michigan United States 48201
4 Research Site Minneapolis Minnesota United States 55407
5 Research Site Basking Ridge New Jersey United States 07920
6 Research Site Hackensack New Jersey United States 07601
7 Research Site Bronx New York United States 10461
8 Research Site New York New York United States 10032
9 Research Site Philadelphia Pennsylvania United States 19104
10 Research Site Pittsburgh Pennsylvania United States 15224
11 Research Site Willow Grove Pennsylvania United States 19090
12 Research Site Providence Rhode Island United States 02905
13 Research Site Germantown Tennessee United States 38138
14 Research Site Houston Texas United States 77030
15 Research Site Leuven Belgium 3000
16 Research Site Namur Belgium 5000
17 Research Site Rio de Janeiro Brazil 22793-080
18 Research Site Plovdiv Bulgaria 4000
19 Research Site Plovdiv Bulgaria 4004
20 Research Site Sofia Bulgaria 1330
21 Research Site Halifax Nova Scotia Canada B3H 1V7
22 Research Site Kingston Ontario Canada K7L 2V7
23 Research Site Mississauga Ontario Canada L5M 2N1
24 Research Site Ottawa Ontario Canada K1H 8L6
25 Research Site Toronto Ontario Canada M4N 3M5
26 Research Site Toronto Ontario Canada M5G 2M9
27 Research Site Montreal Quebec Canada H1T 2M4
28 Research Site Montreal Quebec Canada H2X 0A9
29 Research Site Montreal Quebec Canada H3T 1E2
30 Research Site Montreal Quebec Canada H4A-3J1
31 Research Site Quebec City Quebec Canada G1S 4L8
32 Research Site Brno Czechia 625 00
33 Research Site Brno Czechia 656 53
34 Research Site Olomouc Czechia 779 00
35 Research Site Ostrava Poruba Czechia 708 52
36 Research Site Praha 2 Czechia 128 08
37 Research Site Praha 5 Czechia 150 06
38 Research Site Aalborg Denmark 9000
39 Research Site Kuopio Finland 70210
40 Research Site Lille Cedex France 59020
41 Research Site Lyon France 69373
42 Research Site Plerin France 22190
43 Research Site Villejuif France 94800
44 Research Site Dresden Germany 1307
45 Research Site Budapest Hungary 1032
46 Research Site Budapest Hungary 1122
47 Research Site Haifa Israel 31096
48 Research Site Petah Tikva Israel 49100
49 Research Site Ramat Gan Israel 5265601
50 Research Site Tel Aviv Israel 6423906
51 Research Site Ancona Italy 60020
52 Research Site Bologna Italy 40138
53 Research Site Brescia Italy 25123
54 Research Site Candiolo Italy 10060
55 Research Site Catania Italy 95126
56 Research Site Lecce Italy 73100
57 Research Site Milano Italy 20132
58 Research Site Milan Italy 20141
59 Research Site Napoli Italy 80131
60 Research Site Padova Italy 35128
61 Research Site Roma Italy 00168
62 Research Site Torino Italy 10128
63 Research Site Verona Italy 37134
64 Research Site lJongno-gu Korea, Republic of 03080
65 Research Site Seoul Korea, Republic of 01812
66 Research Site Seoul Korea, Republic of 03080
67 Research Site Seoul Korea, Republic of 03722
68 Research Site Seoul Korea, Republic of 06351
69 Research Site Seoul Korea, Republic of 6351
70 Research Site Białystok Poland 15-027
71 Research Site Grzepnica Poland 72-003
72 Research Site Lublin Poland 20-090
73 Research Site Olsztyn Poland 10-561
74 Research Site Poznań Poland 60-569
75 Research Site Porto Portugal 4200-072
76 Research Site Sankt-Peterburg Russian Federation 197758
77 Research Site Ljubljana Slovenia 1000
78 Research Site Badalona Spain 08916
79 Research Site Barcelona Spain 08035
80 Research Site Barcelona Spain 8907
81 Research Site Barcelona Spain ?08041
82 Research Site Cordoba Spain 14004
83 Research Site Granada Spain 18014
84 Research Site Madrid Spain 28027
85 Research Site Madrid Spain 28041
86 Research Site Madrid Spain 28046
87 Research Site Pamplona Spain 31008
88 Research Site Valencia Spain 46026
89 Research Site Vigo Spain 36312
90 Research Site Zaragoza Spain 50009
91 Research Site Lund Sweden 22185
92 Research Site Ankara Turkey 06230
93 Research Site Istanbul Turkey 34093
94 Research Site Edinburgh United Kingdom EH4 2XU
95 Research Site Glasgow United Kingdom G12 OYN
96 Research Site Hull United Kingdom HU16 5JQ
97 Research Site London United Kingdom SW3 6JJ
98 Research Site Manchester United Kingdom M20 4BX
99 Research Site Taunton United Kingdom TA1 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:
Aug 23, 2022
Last Verified:
Aug 1, 2022
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
HER2-ve metastatic
BRCA mutations
Cancer
Additional relevant MeSH terms:
Olaparib

Study Results

No Results Posted as of Aug 23, 2022