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Pancreatic CancerPhase 3NCT02854072

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

A Phase 3 study testing GV1001, Gemcitabine and Capecitabine in people with Pancreatic Cancer, run by Samsung Pharmaceutical Co., Ltd. at 16 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
GV1001, Gemcitabine and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
148 participants
Where
16 sitesSouth Korea
Study dates
Nov 2015to May 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

16 sites in 1 country.

Hanna Park contact

hpark@kaelgemvax.com

Yoon Jin Lee contact

yjlee@kaelgemvax.com

16 sites in 1 country

South Korea16 sites, 16 recruiting

  • Pusan National University Hospital

    Busan

    Gwang Ha Kim, M.D.

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong

    Joung-Ho Han, M.D.

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Ho Gak Kim, M.D.

    Recruiting

  • Konyang University Hospital

    Daejeon

    Young Woo Choi, M.D.

    Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do

    Woo Jin Lee, M.D.

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Chang-Hwan Park, M.D.

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Jae Hee Cho, M.D.

    Recruiting

  • Jeju National University Hospital

    Jeju City, Jeju-do

    Eun Kwang Choi, M.D.

    Recruiting

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do

    Seung Ok Lee, M.D.

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Jae Yong Cho, M.D.

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Ho Soon Choi, M.D.

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Hong Sik Lee, M.D.

    Recruiting

  • Samsung Medical Center

    Seoul

    Kwang Hyuck Lee, M.D.

    Recruiting

  • Seoul National University Hospital

    Seoul

    Yong-Tae Kim, M.D.

    Recruiting

  • Severance Hospital

    Seoul

    Si Young Song, M.D.

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do

    Kyong Joo Lee, M.D.

    Recruiting

Other trials in South Korea

About this study

Official title: A Prospective, Randomized, Open-label, Multicenter, Parallel Design, Phase III Study to Assess the Efficacy and Safety of GV1001 Concurrent With Gemcitabine/Capecitabine Versus Gemcitabine/Capecitabine Alone in Treating Locally Advanced and Metastatic Pancreatic Cancer Patients

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

Read the detailed 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
Being tested
GV1001, Gemcitabine, Capecitabine
Keywords
GV1001
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GV1001Drug

    Also called Tertomotide

    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.

  • GemcitabineDrug

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

  • 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.

Study groups in NCT02854072
Study groupRoleWhat they receive
GV1001 + gemcitabine/capecitabineExperimentalNot described
Receives: Drug: GV1001; Drug: Gemcitabine; Drug: Capecitabine
gemcitabine/capecitabineActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: one year

Secondary outcomes (8)

  1. Time to tumor progression (TTP)

    Measured: one year

  2. Objective response rate (ORR)

    Objective response rate assesses by CT scan (RECIST and irRC criteria).

    Measured: one year

  3. Clinical benefit response (CBR)

    Measured: one year

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

    Measured: one year

  5. Quality of Life using EORTC QLQ-C30

    Measured: up to one year

  6. Quality of Life using EQ-5D-3L

    Measured: up to one year

  7. Change in CA19-9 (Serum cancer antigen) over time

    Cancer antigen 19-9 (CA 19-9) is used to help differentiate between cancer of the pancreas and other conditions, as well as to monitor treatment response and recurrence.

    Measured: one year

  8. Toxicity according to the NCI CTCAE v4.03

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02854072
Sponsor's protocol ID
KG 4/2015
Status last verified
Jul 2016
First submitted
31 Aug 2015
Last updated
22 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37903909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GV1001, Gemcitabine and Capecitabine in people with Pancreatic Cancer, run by Samsung Pharmaceutical Co., Ltd. at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hanna Park (hpark@kaelgemvax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02854072, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.

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