Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer

Cancer Advances

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: G17DT

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02521649

GC2

Details and patient eligibility

About

An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.

Enrollment: 52 patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

Stage I-III Criteria-

• Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma.

• Absence of metastatic disease evident from:

  • physical examination
  • the most recent chest X-ray
  • abdominal CT or ultrasound scan

• Life expectancy of at least 3 months

• WHO performance status of 0 to 1

• Written informed consent given

Stage IV Criteria-

• Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases
• Life expectancy of at least 3 months
• WHO performance status of 0 to 2
• Written informed consent given

Exclusion criteria

• History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection

• Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies

• Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids

• Females who were pregnant, planning to become pregnant or lactating

• Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study

• Previous G17DT treatment

• Haematological indicators:

  • Haemoglobin <10.0g/dl
  • White blood cell count <4.0 x 109/l
  • Platelets <100 x 109/l

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 5 patient groups

10µg, Stage I-III

Experimental group

Description:

10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Treatment:

Drug: G17DT

100µg, Stage I-III

Experimental group

Description:

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Treatment:

Drug: G17DT

250µg, Stage I-III

Experimental group

Description:

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Treatment:

Drug: G17DT

100µg, Stage IV

Experimental group

Description:

100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Treatment:

Drug: G17DT

250µg, Stage IV

Experimental group

Description:

250µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.

Treatment:

Drug: G17DT