Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer. (GC3)

Cancer Advances

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Biological: G17DT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02233712

GC3

Details and patient eligibility

About

An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
• Male or female and over 18 years of age
• Must have a life expectancy of at least three months
• World Health Organization Performance Status of 0 to 1
• Given written conformed consent

Exclusion criteria

• Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
• History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
• Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
• Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
• Females who pregnant, planning to become pregnant or lactating
• Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
• Previously received G17DT treatment
• Haemoglobin (Hb) < 10.0 g/dL White blood cell count (WBC) < 4.0 x 10^9/L Platelets < 100 x 10^9/L

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Group 1

Experimental group

Description:

G17DT; 250 µg dose administered at 0, 1, and 3 weeks.

Treatment:

Biological: G17DT

Group 2

Experimental group

Description:

G17DT; 100 µg dose administered at 0, 1, and 3 weeks.

Treatment:

Biological: G17DT

Group 3

Experimental group

Description:

G17DT; 500 µg dose administered at 0, 1, and 3 weeks.

Treatment:

Biological: G17DT

Group 4

Experimental group

Description:

G17DT; 500 µg dose administered at 0, 2, and 6 weeks.

Treatment:

Biological: G17DT