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JOURNAL ONKOLOGIE – STUDIE
DG-03

Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03)

Rekrutierend

NCT-Nummer:
NCT04379596

Studienbeginn:
Juni 2020

Letztes Update:
09.06.2021

Wirkstoff:
Fluorouracil (5-FU), Capecitabine, Durvalumab, Oxaliplatin, Trastuzumab, Trastuzumab Deruxtecan, Cisplatin

Indikation (Clinical Trials):
Stomach Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
AstraZeneca

Collaborator:
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 83)

Research Site
60590 Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
90404-2125 Santa Monica
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
66205 Westwood
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48197 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
88020-210 Florianopolis
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
86015-520 Londrina
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90160-093 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
22793-080 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
97015-450 Santa Maria
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01509-900 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
15090-000 São Jose do Rio Preto
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
03102-002 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
045202-001 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
143423 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
630099 Novosibirsk
Russian FederationRekrutierend» Google-Maps
Research Site
195271 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
197022 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
197758 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
CB2 2QQ Cambridge
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
DD1 9SY Dundee
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
EC1A 7BE London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics,

immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or

in combination with chemotherapy and/or durvalumab in HER2-positive advanced/metastatic

gastric/gastroesophageal junction (GEJ) adenocarcinoma patients.

Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or durvalumab

administered to subjects at the recommended phase 2 dose will show manageable safety and

tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing.

T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered

to HER2-positive gastric/GEJ cancer patients who have not received prior treatment for

advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the

potential to become a therapeutic option for this patient population.

Ein-/Ausschlusskriterien

Inclusion criteria:

1. Male and female participants must be at least 18 years of age

2. Disease Characteristics:

Locally advanced, unresectable, or metastatic disease Pathologically documented

adenocarcinoma of the stomach or GEJ with HER2 overexpression (IHC 3+ or ICH 2+/ISH+)

3. For Part 1, progression on or after at least one prior trastuzumab containing Regimen.

For Part 2, previously untreated for unresectable or metastatic adenocarcinoma of the

stomach or GEJ with HER2 overexpression.

4. Has measurable target disease assessed by the Investigator based on RECIST version 1.1

5. Has protocol defined adequate organ function including cardiac, renal and hepatic

function

6. If of reproductive potential, agrees to use a highly effective form of contraception

or avoid intercourse during and upon completion of the study.

Exclusion criteria:

1. History of active primary immunodeficiency, known HIV, active HBV or HCV infection.

2. Uncontrolled intercurrent illness.

3. History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that

cannot be ruled out by imaging at screening.

4. Lung-specific intercurrent clinically significant severe illnesses.

5. Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or

antifungals.

6. Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal

shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).

7. Has spinal cord compression or clinically active central nervous system metastases.

Studien-Rationale

Primary outcome:

1. Part 1: Occurrence of adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Safety will be assessed for approximately 24 months from informed consent.):
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0

2. Part 2: Objective Response Rate (ORR) (Time Frame - An average of approximately 12 months.):
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

Secondary outcome:

1. Part 1: Objective Response Rate (ORR) (Time Frame - An average of approximately 12 months.):
Confirmed ORR per RECIST 1.1 is the percentage of patients with Complete Response or Partial Response that is subsequently confirmed.

2. Part 2: Occurrence of adverse events (AEs) and serious adverse events (SAEs) (Time Frame - Safety will be assessed for approximately 24 months from informed consent.):
Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0

3. Duration of Response (DoR) (Time Frame - An average of approximately 18 months.):
DOR is defined as the time from the date of first documented response until the date of documented progression or death

4. Disease Control Rate (DCR) (Time Frame - An average of approximately 18 months.):
DCR is the percentage of subjects who have a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

5. Progression Free Survival (PFS) (Time Frame - An average of approximately 18 months.):
PFS is the time from date of first dose until the date of objective disease progression or death

6. Overall survival (OS) (Time Frame - An average of approximately 30 months.):
OS is the time from date of first dose until death due to any cause

7. Serum concentration of T-DXd, total anti-HER2 antibody, and MAAA-1181a in all arms (Time Frame - An average of approximately 24 months.):
Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for each dose level for T-DXd, total anti-HER2 antibody, MAAA-1181a

8. Serum concentration of durvalumab in study arms including T-DXd in combination with durvalumab (Time Frame - An average of approximately 24 months.):
Individual participant data and descriptive statistics will be provided for serum concentration data at each time point for durvalumab.

9. Presence of ADAs for T-DXd and durvalumab (in study arms including T-DXd and durvalumab) (Time Frame - An average of approximately 24 months.):
Individual participant data and descriptive statistics will be provided for data at each time point for each dose level for T-DXd and durvalumab.

Studien-Arme

  • Experimental: Arm 1A
    T-DXd and 5-fluorouracil (5-FU)
  • Experimental: Arm 1B
    T-DXd and capecitabine
  • Experimental: Arm 1C
    T-DXd and durvalumab
  • Experimental: Arm 1D(a)
    T-DXd, 5-FU, and oxaliplatin
  • Experimental: Arm 1D(b)
    T-DXd, capecitabine, and oxaliplatin
  • Experimental: Arm 1E(a)
    T-DXd, 5-FU, and durvalumab
  • Experimental: Arm 1E(b)
    T-DXd, capecitabine, and durvalumab
  • Active Comparator: Arm 2A
    Trastuzumab, 5-FU or capecitabine, and cisplatin or oxaliplatin
  • Experimental: Arm 2B
    T-DXd monotherapy
  • Experimental: Arm 2C
    T-DXd, 5-FU or capecitabine, and oxaliplatin
  • Experimental: Arm 2D
    T-DXd, 5-FU or capecitabine, and durvalumab

Geprüfte Regime

  • Fluorouracil (5-FU):
    5-FU: administered as an IV infusion
  • Capecitabine:
    Capecitabine: administered orally
  • Durvalumab (MEDI4736):
    Durvalumab: administered as an IV infusion
  • Oxaliplatin:
    Oxaliplatin: administered as an IV infusion
  • Trastuzumab:
    Trastuzumab: administered as an IV infusion
  • Trastuzumab deruxtecan (DS-8201a):
    T-DXd: administered as an IV infusion
  • Cisplatin:
    Cisplatin: administered as an IV infusion

Quelle: ClinicalTrials.gov


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