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A Phase III Study to Assess the Efficacy and Safety of GV1001-Gem/Cap vs Gem/Cap in Pancreatic Cancer Patients

S

Samsung

Status and phase

Unknown
Phase 3

Conditions

Pancreatic Cancer

Treatments

Drug: Gemcitabine
Drug: GV1001
Drug: Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02854072
KG 4/2015

Details and patient eligibility

About

To assess treatment of GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in locally advanced and metastatic pancreatic cancer patients.

Full description

This study is designed as a phase III, prospective, randomized, open-label, multicenter clinical trial comparing GV1001 concurrent with Gemcitabine/Capecitabine versus Gemcitabine/Capecitabine alone in treating locally advanced and metastatic pancreatic cancer patients. Patients will be treated until disease progression and will be subject to follow-up until death.

Patients will be randomized equally between the two arms:

  1. Gemcitabine and Capecitabine
  2. GV1001+ Gemcitabine and Capecitabine

Enrollment

148 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥ 19 years

  2. Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.

  3. Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer.

  4. Contrast enhanced CT scan of the thorax, abdomen and pelvis within 28 days (and up to a maximum of 32 days) prior to commencing treatment.

  5. Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines.

  6. ECOG performance status 0, 1 or 2.

  7. Adequate organ function as determined by the following laboratory values:

    • Platelets ≥100 x 10^9 /L
    • WBC ≥ 3 x 10^9 /L
    • ANC ≥1.5 x 10^9 /L
    • Serum total bilirubin ≤ 2.0 mg/dL
    • CCr (Cockcroft & Gault) > 50 mL/min
  8. Life expectancy ≥ 90 days

  9. Fully informed written consent given.

Exclusion criteria

  1. Brain metastasis or meningeal carcinomatosis.
  2. Clinically significant serious disease or organ system disease not currently controlled on present therapy.
  3. Previous chemotherapy for locally advanced and metastatic disease. Previously adjuvant chemotherapy for resected pancreatic cancer will be permitted providing chemotherapy was completed more than 12 months previously.
  4. Radiotherapy within the last 8 weeks prior to start of study treatment.
  5. Concurrent malignancies or invasive cancers diagnosed within the past 5 years except for adequately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix or resected pancreatic cancer.
  6. Medication which might affect immunocompetence e.g. chronic treatment with long term steroids or other immunosuppressant for an unrelated condition. Patients will be eligible if they have been receiving short term steroids for palliation of cancer related symptoms.
  7. Administration of medicines from other clinical trials within 8 weeks from registration.
  8. Pregnancy or breast feeding.
  9. Uncontrolled angina pectoris.
  10. Known malabsorption syndromes.
  11. Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
  12. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
  13. Investigator's judgment against participation in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

GV1001 + gemcitabine/capecitabine
Experimental group
Treatment:
Drug: Capecitabine
Drug: Gemcitabine
Drug: GV1001
gemcitabine/capecitabine
Active Comparator group
Treatment:
Drug: Capecitabine
Drug: Gemcitabine

Trial contacts and locations

16

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Central trial contact

Hanna Park; Yoon Jin Lee

Data sourced from clinicaltrials.gov

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