NCT02854072

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at below P25 for phase_3 pancreatic-cancer

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_3 pancreatic-cancer

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 22, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

August 31, 2015

Last Update Submit

November 20, 2016

Conditions

Pancreatic Cancer

Keywords

GV1001

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    one year

Secondary Outcomes (8)

  • Time to tumor progression (TTP)

    one year

  • Objective response rate (ORR)

    one year

  • Clinical benefit response (CBR)

    one year

  • Clinical response with eotaxin level (baseline of serum eotaxin level, pg/mL)

    one year

  • Quality of Life using EORTC QLQ-C30

    up to one year

  • +3 more secondary outcomes

Study Arms (2)

GV1001 + gemcitabine/capecitabine

EXPERIMENTAL
Drug: GV1001Drug: GemcitabineDrug: Capecitabine

gemcitabine/capecitabine

ACTIVE COMPARATOR
Drug: GemcitabineDrug: Capecitabine

Interventions

GV1001DRUG

At week 1, GV1001 will be administered intradermally on day 1, day 3 and day 5. This will be followed by a once weekly schedule for weeks 2, 3, 4 and 6. After that, GV1001 will be administered once monthly until withdrawal from trial treatment due to patient choice, intolerable toxicity or disease progression. GM-CSF will be used as an adjuvant, given 10-15 minutes prior to each administration of GV1001.

Also known as: Tertomotide
GV1001 + gemcitabine/capecitabine
GemcitabineDRUG

Gemcitabine 1000 mg/m\^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.

GV1001 + gemcitabine/capecitabinegemcitabine/capecitabine
CapecitabineDRUG

Capecitabine 830 mg/m\^2 will be orally given in the morning and evening (total dose of 1660 mg/m\^2) for 21 days followed by 7 days' rest.

GV1001 + gemcitabine/capecitabinegemcitabine/capecitabine

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 19 years
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma carcinoma or undifferentiated carcinoma of the pancreas.
  • Locally advanced or metastatic disease precluding curative surgical resection or patients who have relapsed following previously resected pancreatic cancer.
  • 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.
  • Unidimensionally measurable disease (from CT scan) in accordance with the RECIST guidelines.
  • ECOG performance status 0, 1 or 2.
  • 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
  • Life expectancy ≥ 90 days
  • Fully informed written consent given.

You may not qualify if:

  • Brain metastasis or meningeal carcinomatosis.
  • Clinically significant serious disease or organ system disease not currently controlled on present therapy.
  • 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.
  • Radiotherapy within the last 8 weeks prior to start of study treatment.
  • 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.
  • 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.
  • Administration of medicines from other clinical trials within 8 weeks from registration.
  • Pregnancy or breast feeding.
  • Uncontrolled angina pectoris.
  • Known malabsorption syndromes.
  • Patients with a known hypersensitivity to any of the investigational products or patients with a dihydropyrimidine dehydrogenase (DPD) deficiency.
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom.
  • Investigator's judgment against participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

RECRUITING

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Jeju National University Hospital

Jeju City, Jeju-do, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, South Korea

RECRUITING

Pusan National University Hospital

Busan, South Korea

RECRUITING

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

Konyang University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Jo JH, Kim YT, Choi HS, Kim HG, Lee HS, Choi YW, Kim DU, Lee KH, Kim EJ, Han JH, Lee SO, Park CH, Choi EK, Kim JW, Cho JY, Lee WJ, Moon HR, Park MS, Kim S, Song SY. Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomised, Phase 3 trial. Br J Cancer. 2024 Jan;130(1):43-52. doi: 10.1038/s41416-023-02474-w. Epub 2023 Oct 30.

    PMID: 37903909DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GV1001 peptideGemcitabineCapecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Si Young Song, M.D.

    Severance Hospital

    STUDY CHAIR

  • Yong-Tae Kim, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Ho Soon Choi, M.D.

    Hanyang University Seoul Hospital

    PRINCIPAL INVESTIGATOR

  • Ho Gak Kim, M.D.

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

  • Hong Sik Lee, M.D.

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

  • Young Woo Choi, M.D.

    Konyang University Hospital

    PRINCIPAL INVESTIGATOR

  • Gwang Ha Kim, M.D.

    Pusan National University Hospital

    PRINCIPAL INVESTIGATOR

  • Kwang Hyuck Lee, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Jae Hee Cho, M.D.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

  • Joung-Ho Han, M.D.

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

  • Seung Ok Lee, M.D.

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

  • Chang-Hwan Park, M.D.

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

  • Eun Kwang Choi, M.D.

    Jeju National University Hospital

    PRINCIPAL INVESTIGATOR

  • Kyong Joo Lee, M.D.

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

  • Jae Yong Cho, M.D.

    Gangnam Severance Hospital

    PRINCIPAL INVESTIGATOR

  • Woo Jin Lee, M.D.

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Park

CONTACT

hpark@kaelgemvax.com

Yoon Jin Lee

CONTACT

yjlee@kaelgemvax.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

August 3, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

November 22, 2016

Record last verified: 2016-07

Locations

KR(16)