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Metastatic Pancreatic AdenocarcinomaPhase 2ZIPANGNCT02117258

Z-360 Plus GEM in Subjects With Metastatic Pancreatic Adenocarcinoma

A Phase 2 study testing Z-360 in people with Metastatic Pancreatic Adenocarcinoma, run by Zeria Pharmaceutical at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Metastatic Pancreatic Adenocarcinoma
What is being tested?
Z-360
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
167 participants
Where
3 sitesin 3 countries
Study dates
Apr 2014to Mar 2017
Phase
Phase 2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Subjects with histological or cytological evidence of metastatic Pancreatic Adenocarcinoma, Measurable disease or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version criteria
  • 2. Subjects with a life expectancy of at least 12 weeks,
  • 3. Subjects with an Eastern cooperative oncology group performance status (ECOG PS) of 0, 1 or 2,
  • 4. Subjects with the following adequate organ functions:
  • White blood cell count ≥3,000/μL (or absolute neutrophil count ≥1,500/μL) and ≤ 12,000/μL ,
  • Platelet count ≥100.0 × 10^9/L,
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  • Hemoglobin ≥9.0 g/dL,
  • Serum creatinine ≤1.5 × the upper limit normal (ULN),
  • Total bilirubin ≤2.0 × ULN,
  • Serum aspartate transaminase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases), and
  • Serum alanine aminotransferase levels ≤3.0 × ULN (≤5.0 × ULN in presence of liver metastases).

Who cannot join

  • Subjects received the following previous therapies for Pancreatic Adenocarcinoma:
  • Surgery within the 4 weeks prior to randomization,
  • Radiation and chemoradiation within the 12 weeks prior to randomization,
  • Radiation for pain relief within the 4 weeks prior to randomization,
  • Gemcitabine used as a neoadjuvant or an adjuvant on surgery within the 24 weeks prior to randomization,
  • Chemotherapy except GEM used as an adjuvant on surgery within the 4 weeks prior to randomization,
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  • Gemcitabine ≥600 mg/m^2 as sensitizer for chemoradiation,
  • Gemcitabine <600 mg/m^2 as sensitizer for chemoradiation within the 12 weeks prior to randomization,
  • Gemcitabine used for systemic chemotherapy, or
  • Systemic chemotherapies except GEM within the 4 weeks prior to randomization.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Japan1 site

  • Zeria Investigative sites

    Japan

Other trials in Japan

South Korea1 site

  • Zeria Investigative Sites

    Korea

Other trials in South Korea

Taiwan1 site

  • Zeria Investigative Sites

    Dawan

Other trials in Taiwan

About this study

Official title: Randomized Phase II Study of Gemcitabine Plus Z-360 in Metastatic Pancreatic Adenocarcinoma Compared With Gemcitabine Plus Placebo ( ZIPANG Study )

The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.

Being tested
Z-360, Placebo
Keywords
Z-360, Pancreatic cancer, Pancreatic Adenocarcinoma
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Z-360Drug

    Gemcitabine (1,000 mg/m^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while Z-360 (60, 120 or 240 mg) will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.

  • PlaceboDrug

    Gemcitabine (1,000 mg/m^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while placebo will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.

Study groups in NCT02117258
Study groupRoleWhat they receive
Z-360 60mg+GemcitabineExperimentalZ-360 60 mg will be taken orally, twice daily (BID) after a meal.
Receives: Drug: Z-360
Z-360 120mg+GemcitabineExperimentalZ-360 120 mg will be taken orally, twice daily (BID) after a meal.
Receives: Drug: Z-360
Z-360 240mg+GemcitabineExperimentalZ-360 240 mg will be taken orally, twice daily (BID) after a meal.
Receives: Drug: Z-360
Placebo+GemcitabinePlacebo comparatorPlacebo will be taken orally, twice daily (BID) after a meal.
Receives: Drug: Placebo

What is being measured

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

  1. Overall Survival

    Measured: Approximately 24 months

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    Measured: Approximately 24 months

  2. Time to Treatment Failure

    Measured: Approximately 24 months

  3. Quality of Life

    Measured: Approximately 24 months

  4. Safety parameters

    Incidence of SAEs and AEs, laboratory test results, vital signs, ECG results and physical examination findings

    Measured: Approximately 24 months

  5. Pharmacokinetics

    To characterize the plasma pK of Z-360 when given in combination with GEM

    Measured: Day1

  6. Response Rate

    Measured: Approximately 24 months

  7. Benefit Rate

    Measured: Approximately 24 months

Timeline

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

  1. First posted17 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJul 2016
  4. Study completionMar 2017

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02117258
Sponsor's protocol ID
Z-360-01
Acronym
ZIPANG
Status last verified
Jun 2017
First submitted
7 Apr 2014
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Z-360 in people with Metastatic Pancreatic Adenocarcinoma, run by Zeria Pharmaceutical at 3 sites in 3 countries.

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 11 inclusion and 10 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan, South Korea, Taiwan. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Approximately 24 months). 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 NCT02117258.

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 2 Jul 2017.

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