JOURNAL ONKOLOGIE – STUDIE
ADAGIO A Study of Adavosertib as Treatment for Uterine Serous Carcinoma
Rekrutierend
NCT-Nummer:
NCT04590248
Studienbeginn:
November 2020
Letztes Update:
20.01.2021
Wirkstoff:
Adavosertib
Indikation (Clinical Trials):
Carcinoma, Cystadenocarcinoma, Serous
Geschlecht:
Frauen
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
AstraZeneca
Collaborator:
Parexel
Studienleiter
Principal Investigator
Dana-Farber Cancer Institute
Kontakt
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen
Studienlocations (3 von 43)
Research Site
D-13353 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-MapsResearch Site
53127 Bonn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsResearch Site
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
D-13353 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-MapsResearch Site
53127 Bonn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-MapsResearch Site
91054 Erlangen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
35233 Birmingham
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
91505 Burbank
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91010 Duarte
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
92093 La Jolla
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90048 Los Angeles
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
80045 Aurora
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30214 Fayetteville
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60637 Chicago
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
52242 Iowa City
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70433 Covington
United StatesRekrutierend» Google-MapsResearch Site
02215 Boston
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01605 Worcester
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55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
55905-0001 Rochester
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08903 New Brunswick
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
10467 Bronx
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10065 New York
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
44109-1998 Cleveland
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
19111 Philadelphia
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84106 Salt Lake City
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
99202 Spokane
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98684 Vancouver
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-MapsResearch Site
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-MapsResearch Site
21079 Dijon cedex
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13273 Marseille
FranceNoch nicht rekrutierend» Google-MapsResearch Site
6189 Nice
FranceNoch nicht rekrutierend» Google-MapsResearch Site
69495 Pierre Benite
FranceNoch nicht rekrutierend» Google-MapsResearch Site
44805 Saint Herblain
FranceRekrutierend» Google-MapsResearch Site
40138 Bologna
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
10060 Candiolo
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
95100 Catania
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
73100 Lecce
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
20141 Milan
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
80131 Napoli
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
00168 Roma
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
15009 A Coruña
SpainNoch nicht rekrutierend» Google-MapsResearch Site
08035 Barcelona
SpainRekrutierend» Google-MapsResearch Site
08036 Barcelona
SpainRekrutierend» Google-MapsResearch Site
28223 Pozuelo de Alarcón
SpainNoch nicht rekrutierend» Google-Maps
Alle anzeigen 35233 Birmingham
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
91505 Burbank
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
91010 Duarte
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
92093 La Jolla
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
90048 Los Angeles
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
80045 Aurora
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
30214 Fayetteville
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
60637 Chicago
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
52242 Iowa City
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
70433 Covington
United StatesRekrutierend» Google-MapsResearch Site
02215 Boston
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
01605 Worcester
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
55905-0001 Rochester
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
08903 New Brunswick
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
10467 Bronx
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
10065 New York
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
44109-1998 Cleveland
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
19111 Philadelphia
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
84106 Salt Lake City
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
99202 Spokane
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
98684 Vancouver
United StatesNoch nicht rekrutierend» Google-MapsResearch Site
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-MapsResearch Site
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-MapsResearch Site
21079 Dijon cedex
FranceNoch nicht rekrutierend» Google-MapsResearch Site
13273 Marseille
FranceNoch nicht rekrutierend» Google-MapsResearch Site
6189 Nice
FranceNoch nicht rekrutierend» Google-MapsResearch Site
69495 Pierre Benite
FranceNoch nicht rekrutierend» Google-MapsResearch Site
44805 Saint Herblain
FranceRekrutierend» Google-MapsResearch Site
40138 Bologna
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
10060 Candiolo
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
95100 Catania
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
73100 Lecce
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
20141 Milan
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
80131 Napoli
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
00168 Roma
ItalyNoch nicht rekrutierend» Google-MapsResearch Site
15009 A Coruña
SpainNoch nicht rekrutierend» Google-MapsResearch Site
08035 Barcelona
SpainRekrutierend» Google-MapsResearch Site
08036 Barcelona
SpainRekrutierend» Google-MapsResearch Site
28223 Pozuelo de Alarcón
SpainNoch nicht rekrutierend» Google-Maps
Studien-Informationen
Detailed Description:This Phase 2b, open-label, single-arm, multi-center study will assess the efficacy and safety
of adavosertib in eligible subjects with histologically confirmed recurrent or persistent
USC, evidence of measurable disease as per Response Evaluation Criteria in Solid
Tumors.(RECIST) v1.1, and who have received at least 1 prior platinum-based chemotherapy
regimen for the management of USC. Subjects with carcinosarcomas are not eligible.
Ein-/Ausschlusskriterien
Inclusion Criteria:1. Subjects must be aged ≥ 18 years of age inclusive, at the time of signing the informed
consent.
2. Histologically confirmed recurrent or persistent USC. Subjects with carcinosarcomas
are not eligible.
3. Evidence of measurable disease as per RECIST v1.1.
4. At least 1 prior platinum-based chemotherapy regimen for the management of USC. Prior
receipt of immune checkpoint inhibitors, vascular endothelial growth factor (VEGF)
inhibitors and human epidermal growth factor receptor 2 (HER2) targeted therapy is
allowed. There is no restriction on the number of prior lines of systemic therapy.
5. Eastern Cooperative Oncology Group performance (ECOG) status 0-1.
6. Life expectancy ≥ 12 weeks.
7. Subjects must have normal organ and marrow function at baseline, within 7 days prior
to study drug administration.
8. Consent to submit and provide a mandatory Formalin-fixed paraffin-embedded tumor
sample for central testing.
9. Female subjects who are not of childbearing potential and women of childbearing
potential who agree to use adequate contraceptive measures.
Exclusion Criteria:
1. Any underlying medical condition and uncontrolled intercurrent illness that would
impair the ability of the subject to receive study treatment, as judged by the
investigator.
2. With the exception of alopecia, any unresolved toxicities from prior therapy greater
than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of
starting study treatment.
3. Unable to swallow oral medications.
4. Spinal cord compression or metastases unless asymptomatic, stable, and not requiring
steroids for at least 4 weeks prior to start of study intervention.
5. Subjects with current signs or symptoms of bowel obstruction, including sub-occlusive
disease, related to underlying disease.
6. Any of the following cardiac diseases currently or within the last 6 months:
- Unstable angina pectoris
- Acute myocardial infarction
- Congestive heart failure
- Conduction abnormality not controlled with pacemaker or medication
- Significant ventricular or supraventricular arrhythmias
7. History of Torsades de pointes unless all risk factors that contributed to Torsades
have been corrected.
8. a) Resting corrected QTc interval using the Fridericia formula (QTcF) > 480 msec, or
b) congenital long QT syndrome.
9. Immunocompromised subjects.
10. Subjects with known active hepatitis (ie, hepatitis B or C).
11. Prior treatment with any of the following:
- Cell cycle checkpoint inhibitor.
- Anticancer treatment drug ≤ 21 days (≤ 6 weeks for nitrosoureas or mitomycin C)
or use of an investigational product within 5 half-lives prior to the first dose
of adavosertib. For Programmed cell death-1 receptor (PD-1) /Programmed
death-ligand 1 (PD-L1) inhibitors, a minimum of 28 days since last dose is
required.
- Prescription or non-prescription drugs known as moderate to strong inhibitors /
inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment.
- Herbal medications 7 days prior to first dose of study treatment.
12. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide
field of radiation within 4 weeks prior to the first dose of study intervention.
13. Major surgical procedures ≤ 28 days, or minor surgical procedures ≤ 7 days, prior to
beginning study.
14. Subjects with a known hypersensitivity or contraindication to adavosertib or any of
the excipients of the product.
15. Currently pregnant or breast-feeding.
Studien-Rationale
Primary outcome:1. Objective response rate (ORR) (Time Frame - From baseline to approximately 24 months):
The percentage of subjects with measurable disease at baseline who have a confirmed complete response (CR) or partial response (PR), as determined by Blinded Independent Central Review (BICR) per RECIST v1.1
Secondary outcome:
1. Duration of response (DoR) (Time Frame - From baseline to approximately 24 months):
The time from the date of first documented response until date of documented progression per RECIST v1.1 as assessed by BICR, or death in the absence of disease progression
2. Depth of response (Time Frame - From baseline to approximately 24 months):
Absolute change and percentage change from baseline will be based on RECIST v1.1 target lesions measurements
3. Progression free survival (PFS) (Time Frame - From baseline to approximately 24 months):
The time from first dose until the date of objective disease progression or death (by any cause in the absence of progression), derived using RECIST v1.1 assessments based on BICR data
4. PFS6 (Time Frame - From baseline up to 6 months):
The proportion of subjects alive and progression free at 6 months by Kaplan-Meier estimate
5. Overall survival (OS) (Time Frame - From baseline to approximately 24 months):
The time from date of first dose until the date of death due to any cause
6. Disease control rate (DCR) (Time Frame - From baseline to approximately 24 months):
The percentage of subjects who have a best response of confirmed CR or PR or who have stable disease for at least 5 weeks after start of treatment, based on BICR data
7. Lowest concentration (Ctrough) of adavosertib (Time Frame - Pre-dose (60 minutes prior to dosing) on Day 5 of Cycles 1 and 2 (each cycle is 21 days)):
Lowest plasma concentration of adavosertib before next dose
8. Maximum concentration (Cmax) of adavosertib (Time Frame - 2 hours post-dose on Day 5 of Cycles 1 and 2 (each cycle is 21 days)):
Maximum plasma concentration of adavosertib after oral dosing
9. Number of subjects with adverse events (AE) and serious AEs (Time Frame - From baseline to post-treatment follow-up (30 days after last dose)):
Assessment of AEs, vital signs, clinical laboratory values, electrocardiogram findings, and AEs leading to dose interruptions, dose reductions, and dose discontinuations
Geprüfte Regime
- Adavosertib (AZD1775):
The subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
Quelle: ClinicalTrials.gov