Trial Title:
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
NCT ID:
NCT06380751
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Fulvestrant
Palbociclib
Anastrozole
Exemestane
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
Open label
Intervention:
Intervention type:
Drug
Intervention name:
Saruparib (AZD5305)
Description:
Saruparib (AZD5305) is a potent and selective inhibitor of PARP1, with minimal effect on
PARP2.
Arm group label:
Arm 1: saruparib (AZD5305) plus camizestrant
Intervention type:
Drug
Intervention name:
Camizestrant
Description:
Camizestrant (AZD9833) is an orally bioavailable, next generation SERD with non-clinical
and clinical activity in both ESR1 mutant and wild type settings .
Arm group label:
Arm 1: saruparib (AZD5305) plus camizestrant
Arm group label:
Arm 3: Physician's choice CDK4/6i plus camizestrant
Intervention type:
Drug
Intervention name:
Abemaciclib
Description:
CDK4/6 Inhibitor
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Arm group label:
Arm 3: Physician's choice CDK4/6i plus camizestrant
Intervention type:
Drug
Intervention name:
Ribociclib
Description:
CDK4/6 Inhibitor
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Arm group label:
Arm 3: Physician's choice CDK4/6i plus camizestrant
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
CDK 4/6 Inhibitor
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Arm group label:
Arm 3: Physician's choice CDK4/6i plus camizestrant
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Endocrine Therapy
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Intervention type:
Drug
Intervention name:
Letrozole
Description:
Endorcine Therapy
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
Endocrine Therapy
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Intervention type:
Drug
Intervention name:
Exemestane
Description:
Endocrine Therapy
Arm group label:
Arm 2: Physician's choice CDK4/6i plus physician's choice ET
Summary:
The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus
camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1,
BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH
non-amplified) advanced breast cancer.
Detailed description:
Approximately 2,620 participants will be screened to achieve approximately 500
participants randomised to study intervention.
Participants will be randomised in a 2:2:1 ratio to one of the following intervention
groups:
- Arm 1: saruparib (AZD5305) plus camizestrant
- Arm 2: Physician's choice CDK4/6i plus physician's choice ET
- Arm 3: Physician's choice CDK4/6i plus camizestrant Treatment continues until
BICR-confirmed disease progression, unacceptable toxicity occurs, or the participant
withdraws consent.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult females, pre/peri-menopausal and/or post-menopausal, and adult males
- Histologically or cytologically documented diagnosis of HR-positive, HER2-negative
breast cancer
- Advanced breast cancer with either locally advanced disease not amenable to curative
treatment or metastatic disease
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks
- FFPE tumour tissue from each participant
- Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2
- Adequate organ and marrow function
Exclusion Criteria:
- Participants with history of MDS/AML or with features suggestive of MDS/AML
- Participants with any known predisposition to bleeding
- Any history of persisting severe cytopenia
- Any evidence of severe or uncontrolled systemic diseases or active uncontrolled
infections
- Refractory nausea and vomiting, chronic GI disease, inability to swallow the
formulated product, or previous significant bowel resection
- History of another primary malignancy
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy
excluding alopecia
- Spinal cord compression, brain metastases, carcinomatous meningitis, or
leptomeningeal disease
- Evidence of active and uncontrolled hepatitis B and/or hepatitis C
- Evidence of active and uncontrolled HIV infection
- Active tuberculosis infection
- Cardiac criteria, including history of arrythmia and cardiovascular disease
- Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy
for non-cancer-related conditions
- Major surgical procedure or significant traumatic injury within 4 weeks of the first
dose of study intervention or an anticipated need for major surgery during the study
- Palliative radiotherapy with a limited field of radiation within 2 weeks or with
wide field of radiation or to more than 30% of the bone marrow within 4 weeks before
the first dose of study treatment
- Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or
metastatic disease is not permitted, apart from treatment with ET up to 28 days
before randomisation
- Prior treatment within 28 days with blood product support or growth factor support
- Any systemic concurrent anti-cancer treatment
- Concomitant use of the following types of medications or herbal supplements within
21 days or at least 5 half-lives of randomisation:
1. Strong and moderate CYP3A4 inducers/inhibitors
2. Sensitive CYP2B6 substrates
3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg,
warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and
phenytoin.
- Concomitant use of drugs that are known to prolong QT and have a known risk of TdP
- Systemic use of atropine
- The following exclusion criteria apply to treatments administered for early breast
cancer:
1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or
adjuvant chemotherapy
2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a
PARPi and/or platinum agent for early breast cancer
3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in
the adjuvant setting
4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD
including camizestrant.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
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City:
Gilbert
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85234
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United States
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Los Angeles
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Orlando
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32806
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Chicago
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60611
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60201
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46227
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40207
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20902
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48073
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11220
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11501
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10016
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New York
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10028
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10065
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Houston
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2010
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Melbourne
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Montreal
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Montreal
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Montréal
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Toronto
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Bengbu
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Changsha
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410008
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Changsha
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410013
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China
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Foshan
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528000
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Guangzhou
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510060
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Hefei
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230031
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Nanjing
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210029
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Wuhan
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Wuhan
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430030
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Wuhan
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Angers
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Lille
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Budapest
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33905
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342005
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Kolkata
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700160
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India
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Luknow
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226003
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India
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Mumbai
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400012
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India
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Mumbai
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400052
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India
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Mysuru
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570017
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India
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Nagpur
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440001
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India
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City:
Nashik
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422002
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India
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City:
New Delhi
Zip:
110085
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India
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Address:
City:
Surat
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396007
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India
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Bologna
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40138
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Italy
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Milano
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20132
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Italy
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Milano
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20141
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Italy
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Modena
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41124
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Italy
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Napoli
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80131
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Italy
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Padova
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35128
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Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba-shi
Zip:
260-8717
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hidaka-shi
Zip:
350-1298
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hirakata-shi
Zip:
573-1191
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Isehara-shi
Zip:
259-1193
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kashiwa
Zip:
227-8577
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kumamoto-shi
Zip:
860-8556
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kyoto-shi
Zip:
606-8507
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Matsuyama-shi
Zip:
791-0280
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
466-8560
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
467-8602
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Osaka-shi
Zip:
541-8567
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ota-shi
Zip:
373-8550
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sapporo-shi
Zip:
003-0804
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sendai-shi
Zip:
980-8574
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Shinagawa-ku
Zip:
142-8666
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Suita-shi
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Takasaki-shi
Zip:
370-0829
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tsu-shi
Zip:
514-8507
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Yokohama-shi
Zip:
241-8515
Country:
Japan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
3722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Biała Podlaska
Zip:
21-500
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Poznań
Zip:
61-485
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Łódź
Zip:
93-338
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
San Juan
Zip:
00918
Country:
Puerto Rico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Caceres
Zip:
10003
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Granada
Zip:
18007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
L'Hospitalet de Llobregat
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Valencia
Zip:
46006
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taichung
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
112
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
23561
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taoyuan
Zip:
00333
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10210
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Dusit
Zip:
10300
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ratchathewi
Zip:
10400
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Adapazari
Zip:
54290
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Altındağ-Ankara
Zip:
06230
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Istanbul
Zip:
34214
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kayseri
Zip:
38039
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Çankaya
Zip:
06680
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Cambridge
Zip:
CB2 2QQ
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Guildford
Zip:
GU2 7XX
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Taunton
Zip:
TA1 5DA
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
August 1, 2024
Completion date:
October 18, 2030
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06380751
