Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

PHASE1CompletedINTERVENTIONAL
Enrollment

285

Participants

Timeline

Start Date

December 1, 2010

Primary Completion Date

April 26, 2019

Study Completion Date

December 3, 2024

Conditions
Advanced Solid MalignancySafety and TolerabilityPharmacokineticsPharmacodynamicsTumour ResponseAdvanced or Metastatic Breast CancerOvarian CancerCervical CancerEndometrial CancerPIK3CAAKT1PTENER PositiveHER2 Positive
Interventions
DRUG

AZD5363

Patients will receive a single dose of AZD5363, administered orally, followed by a 3-7 day wash-out period. Patients will then commence with twice-daily dosing, administered orally, every day, to cessation of therapy.

DRUG

AZD5363

Patients will be given AZD5363 administered orally as a single dose, followed by a 3-7 day wash-out period. Patients will then receive AZD5363 twice daily on 6 or fewer days per weekly regimen, to cessation of therapy. Parts C,D: Oral AZD5363 twice daily, 4 days on treatment, 3 days off treatment, to cessation of therapy.

DRUG

AZD5363

Optional additional schedule. Patients will be given AZD5363 administered orally. Regimen to be determined in response to emerging clinical findings.

DRUG

AZD5363

Patients will receive oral AZD5363 twice daily (4 days on 3 days off treatment)combined with background therapy of fulvestrant at licensed dose of 500mg intramuscularly on days 1,15,29 and once monthly thereafter.

Trial Locations (34)

2100

Research Site, København Ø

10022

Research Site, New York

20141

Research Site, Milan

28041

Research Site, Madrid

29425

Research Site, Charleston

37203

Research Site, Nashville

37204

Research Site, Nashville

46010

Research Site, Valencia

59100

Research Site, Prato

69310

Research Site, Pierre-Bénite

73104

Research Site, Oklahoma City

75248

Research Site, Paris

77030

Research Site, Houston

80045

Research Site, Aurora

80131

Research Site, Napoli

90048

Research Site, West Hollywood

90089

Research Site, Los Angeles

94304

Research Site, Stanford

94805

Research Site, Villejuif

97239

Research Site, Portland

119228

Research Site, Singapore

02215

Research Site, Boston

T6G 1Z2

Research Site, Edmonton

V5Z 4E6

Research Site, Vancouver

M5G 2M9

Research Site, Toronto

H4A 3T2

Research Site, Montreal

104-0045

Research Site, Chūōku

277-8577

Research Site, Kashiwa

135-8550

Research Site, Kōtoku

060-8638

Research Site, Sapporo

1066 CX

Research Site, Amsterdam

08035

Research Site, Madrid

M20 4BX

Research Site, Manchester

SM2 5PT

Research Site, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY