Trial Title:
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies
NCT ID:
NCT04644068
Condition:
Ovarian Cancer
Breast Cancer
Pancreatic Cancer
Prostate Cancer
Additional Indications Below for Module 4 and 5
Non-small Cell Lung Cancer
Colorectal Cancer
Bladder Cancer
Gastric Cancer
Biliary Cancer
Cervical Cancer
Endometrial Cancer
Small Cell Lung Cancer Only in Module 5
Conditions: Official terms:
Lung Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Small Cell Lung Carcinoma
Endometrial Neoplasms
Paclitaxel
Carboplatin
Conditions: Keywords:
PARP inhibitor
Breast Cancer
Pancreatic Cancer
Prostate Cancer
Ovarian Cancer
AZD5305, T-DXd, Enhertu, Trastuzumab Deruxtecan, Dato-DXd, Datopotamab Deruxtecan, Camizestrant
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
The study consists of individual modules each evaluating the safety and tolerability of
AZD5305 dosed as monotherapy, or with a specific combination partner:
- Module 1 (AZD5305 monotherapy)
- Module 2 (AZD5305 in combination with paclitaxel)
- Module 3 (AZD5305 in combination with carboplatin, with or without paclitaxel)
- Module 4 (AZD5305 in combination with T DXd)
- Module 5 (AZD5305 in combination with Dato-DXd).
- Module 6 (AZD5305 in combination with Camizestrant)
Modules 1 and 4 has 2 study parts: Part A consisting of dose-escalation cohorts and Part
B, consisting of expansion cohorts. Modules 2, 3, 5 and 6 have only PART A.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD5305
Description:
Oral PARP inhibitor
Arm group label:
Module 1: AZD5305 Monotherapy
Arm group label:
Module 2: AZD5305 + Paclitaxel
Arm group label:
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
Arm group label:
Module 4: AZD5305 + Trastuzumab Deruxtecan
Arm group label:
Module 5 AZD5305 + Datopotamab Deruxtecan
Arm group label:
Module 6 AZD5305 + Camizestrant
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
IV Anti-microtubule agent
Arm group label:
Module 2: AZD5305 + Paclitaxel
Arm group label:
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV Platinum chemotherapeutic
Arm group label:
Module 3: AZD5305 + Carboplatin with or without Paclitaxel
Intervention type:
Drug
Intervention name:
T- Dxd
Description:
IV Antibody-drug conjugate
Arm group label:
Module 4: AZD5305 + Trastuzumab Deruxtecan
Intervention type:
Drug
Intervention name:
Dato-DXd
Description:
IV Antibody-drug conjugate
Arm group label:
Module 5 AZD5305 + Datopotamab Deruxtecan
Intervention type:
Drug
Intervention name:
Camizestrant
Description:
Oral SERD Molecule
Arm group label:
Module 6 AZD5305 + Camizestrant
Summary:
This research is designed to determine if experimental treatment with PARP inhibitor,
AZD5305, alone, or in combination with anti-cancer agents is safe, tolerable, and has
anti-cancer activity in patients with advanced solid tumors.
Detailed description:
This study is a Phase I/IIa modular, open-label, multi-center study of AZD5305
administered orally, either as monotherapy or in combination with other anti-cancer
agents in patients with advanced solid malignancies.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Age ≥ 18 at the time of screening
- Histological or cytological confirmation of advanced malignancy considered to be
suitable for study treatment and meeting module specific eligibility criteria..
- Eastern Cooperative Oncology Group Performance status (ECOG PS: 0-2)
- Life expectancy ≥ 12 weeks
- Progressive cancer at the time of study entry
- Patients must have evaluable disease as defined in module-specific criteria for Part
A and Part B
- Adequate organ and marrow function as defined by the protocol.
- For Part B expansion cohorts: Provision of formalin-fixed and paraffin embedded
(FFPE) tumour specimen is mandatory, where available, except if stated that it is
optional in a specific Module.
For Part A:
- Patients may have received up to one prior line of therapy with a PARPi-based
regimen (either as a treatment or as maintenance)
For Part B:
- Patients must not have received prior therapy with a PARPi-based regimen (either as
a treatment or as maintenance).
Key Exclusion Criteria:
- Treatment with any of the following:
1. Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
2. Any investigational agents or study drugs from a previous clinical study within
5 half-lives or 3 weeks (whichever is shorter) of the first dose of study
treatment
3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of
the first dose of study treatment
4. Any live virus or bacterial vaccine within 28 days of the first dose of study
treatment
- Concomitant use of medications or herbal supplements known to be cytochrome P450 3A4
(CYP3A4) strong and moderate inhibitors or inducers.
- Concomitant use of drugs that are known to prolong or shorten QT and have a known
risk of Torsades de Pointes.
- Receiving continuous corticosteroids at a dose of >10 mg prednisone/day or
equivalent for any reason.
- Major surgery within 4 weeks of the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a
limited field of radiation for palliation within 2 weeks of the first dose of study
treatment.
- Any history of persisting (> 2 weeks) severe pancytopenia due to any cause
- Spinal cord compression or brain metastases unless asymptomatic, treated and stable
and not requiring continuous corticosteroids at a dose of >10mg prednisone/day or
equivalent for at least 4 weeks prior to start of study treatment. Patients with
leptomeningeal carcinomatosis are excluded.
- patient with known predisposition to bleeding (e.g., active peptic ulceration,
recent [within 6 months] haemorrhagic stroke, proliferative diabetic retinopathy).
- Cardiac conditions as defined by the clinical study protocol
- Other cardiovascular diseases as defined by any of the following:
1. Symptomatic heart failure,
2. uncontrolled hypertension,
3. hypertensive heart disease with significant left ventricular hypertrophy
4. acute coronary syndrome (ACS)/acute myocardial infarction (AMI), unstable
angina pectoris, coronary intervention procedure with percutaneous coronary
intervention (PCI) or coronary artery bypass grafting (CABG) within 6 months.
5. cardiomyopathy of any etiology
6. presence of clinically significant valvular heart disease
7. history of atrial or ventricular arrhythmia requiring treatment; subjects with
atrial fibrillation and optimally controlled ventricular rate (< 100 beats per
minute) are permitted.
8. subjects with atrial fibrillation and optimally controlled ventricular rate are
permitted
9. transient ischaemic attack, or stroke within 6 months prior to screening
10. patients with symptomatic hypotension at screening
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features
suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML).
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to
swallow the formulated product or previous significant bowel resection that would
preclude adequate absorption of AZD5305
- Known allergy or hypersensitivity to investigational product(s) or any of the
excipients of the investigational product(s).
Prior malignancy whose natural history, in the Investigator's opinion, has the potential
to interfere with safety and efficacy assessments of the investigational regimen.
other module-specific criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
130 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
New York
Zip:
10021
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kelowna
Zip:
V1Y 5L3
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Vancouver
Zip:
V5Z 1K1
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
N6A 4L6
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H2X 0A9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quebec
Zip:
G1R 2J6
Country:
Canada
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Completed
Facility:
Name:
Research Site
Address:
City:
Jining
Zip:
272029
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shandong
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taiyuan
Zip:
030001
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brno
Zip:
656 53
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Praha
Zip:
15006
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1062
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1082
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Budapest
Zip:
1122
Country:
Hungary
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Modena
Zip:
41125
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Padova
Zip:
35128
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gdańsk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gdynia
Zip:
81-519
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Grzepnica
Zip:
72-003
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-501
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Toruń
Zip:
87-100
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Łódź
Zip:
90-302
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
111123
Country:
Russian Federation
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
115478
Country:
Russian Federation
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
117997
Country:
Russian Federation
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Moscow
Zip:
143442
Country:
Russian Federation
Status:
Terminated
Facility:
Name:
Research Site
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chernivtsі
Zip:
58013
Country:
Ukraine
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ivano-Frankivsk
Zip:
76018
Country:
Ukraine
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Uzhgorod
Zip:
88000
Country:
Ukraine
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Recruiting
Start date:
November 12, 2020
Completion date:
March 3, 2027
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/NCT04644068
https://www.breastcancerstudylocator.com/trial/listing/260668
