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Pancreatic CancerPhase 2/3NCT04183478

The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer

A Phase 2/3 study testing K-001 in people with Pancreatic Cancer, run by RenJi Hospital at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
K-001
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
1 siteChina
Study dates
26 Sep 2017to Mar 2021
Phase
Phase 2/3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 18 years.
  • Metastatic or locally advanced pancreatic ductal adenocarcinoma which is confirmed by primary and/or metastatic pathology/cytology examination.
  • Had received at least 2 lines chemotherapy regimen, and the disease is progression or the toxicity could not be tolerated.
  • At least 28 days after the last chemotherapy.
  • Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1).
  • Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
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  • Adequate hepatic, renal, and hematologic functions (neutrophils ≥1.5×10^9/L, platelets ≥ 80×10^9/L,hemoglobin ≥90g/L, total bilirubin within 2.0×the upper limit of normal(ULN), albumin≥30g/L, and ALT and AST≤3×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN and creatinine clearance rate > 30ml/min (Cockcroft-Gault).
  • For women of child-bearing age, the pregnancy test results (serum or urine) within 14 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 60 days post the last administration of study drug.
  • Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Who cannot join

  • Patients is not confirmed by pathology/cytology examination as pancreatic ductal adenocarcinoma.
  • Target lesions were once treated locally and does not exhibit progression recently.
  • Patients with already diagnosed central nervous system metastasis. Patients with clinical symptoms of central nervous system metastasis should be examined by MRI.
  • Patients with Vater 's ampullary carcinoma or biliary adenocarcinoma.
  • Subject with partial or complete intestinal obstruction,or complete biliary obstruction who are unable to be relieved by active treatment
  • Subject has more than an average of intra-abdominal effusion, or the intra-abdominal effusion could not be control in 2 weeks.
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  • Subject has a second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers treated with curative intent and no known active disease within 5 years before planned start of study therapy.
  • Female subjects who are pregnant, planning a pregnancy or breast feeding during the study.
  • Subject has an active infection, or a hypertension could not be controlled by drugs, or angina diagnosed within 3 months, or unstable angina pectoris, or myocardial infarction diagnosed within 1 year, or with congestive heart failure (New York Heart Association [NYHA] Class II or III or IV), or with schizophrenia, or with the history of psychotropic substance abuse.
  • Subject has an active infection of hepatitis B (HBV), hepatitis C (HCV) or human immunodeficiency virus (HIV).
  • Subject has received any of the following treatment within the framework of a specific time frame prior to entry:
  • received operation greater than grade II within 4 weeks;
  • received extended range radiotherapy within 4 weeks, or locally radiotherapy within 2 weeks;
  • participated in other therapeutic/interventional clinical trials within 4 weeks;
  • received locally anti-tumor therapy within 4 weeks；
  • All toxic effects of any prior antitumor therapy resolved to Grade < 2 before the start of study therapy (with the exception of alopecia and pigmentation of skin).
  • Subject has known to be allergic or intolerant to K-001 and its excipients.
  • Other situations that the researchers considered inappropriate for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

Jiujie Cui, MD contact

86-21-68385559

cuijiujie@126.com

Xinlei Gong, MD contact

86-25-80864049

xinleigong@medmail.com.cn

China1 site, 1 recruiting

  • RenJiH

    Shanghai, Shanghai Municipality, 200127

    Liwei Wang, Professor, 86-21-68385559, lwwang2013@163.com

    Jiujie Cui, MD, 86-21-68385559, cuijiujie@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double Blinded, Parallel-controlled, Multi-center Phase II/III Study to Compare the Best Support Care (BSC) Plus K-001 Versus BSC Plus Placebo for the Third-line and Later Treatment of Patients With Advanced Pancreatic Cancer

No Standard therapy has been approved for third-line therapy of advanced pancreatic cancer. K001 is peptidoglycan prepared from the marine microorganism, with an anti-tumor activity. Previously, the phase I study of K001 has shown that K001 was safety and had some effectiveness for pancreatic patients. Now, we would like to lunch a randomized, blinded, parallel-controlled, multi-center phase II/III study to compare the best support care (BSC) plus K-001 versus BSC plus placebo for the third-line and later treatment of patients with advanced pancreatic cancer.

Being tested
K-001, placebo
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • K-001Drug

    K-001 is an antitumor active substance (peptidoglycan) which is prepared from the fermentation product of marine microorganism. K-001 is the Chinese first class new drug and get patent licensing in China, America and Japan.

  • placeboOther

    Also called K-001 placebo

    Placebo which looks the same as K-001 in apparence

Study groups in NCT04183478
Study groupRoleWhat they receive
Best Support Care Plus K-001ExperimentalBest support care including analgesic treatment, anti-infection therapy, biliary obstruction treatment, nutritional support, psychological support, reasonable advice from physicians, good communication with patients and etc. K-001 9,720mg per day which means that take K-001 capsule 18 tablets (270mg per tablet) orally twice a day (morning and evening), 56 days as a cycle.
Receives: Drug: K-001
Best Support Care Plus placeboPlacebo comparatorBest support care is the same as experimental arm. Placebo is take 18 placebo tablets which is the same as K-001 in appearance orally twice a day (morning and evening), 56 days as a cycle.
Receives: Other: placebo

What is being measured

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

  1. overall survival

    The overall survival (OS) of the two groups of FAS was compared. FAS including all the subjects who take at least one dose of the research drug. All the subjects received tumor assessment every 8weeks according to RECIST1.1.

    Measured: 6 months after the last subject is enrolled

Secondary outcomes (6)

  1. PFS

    All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the progression-free survival (PFS) .

    Measured: 6 months after the last subject is enrolled

  2. TTP

    All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the time to progression (TTP).

    Measured: 6 months after the last subject is enrolled

  3. ORR

    All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the objective response rate (ORR).

    Measured: 6 months after the last subject is enrolled

  4. DCR

    All the subjects received tumor assessment every 8weeks according to RECIST1.1 to evaluate the disease control rate (DCR).

    Measured: 6 months after the last subject is enrolled

  5. CBR

    According to a questionaire to evaluate the clinical benefit response (CBR) of the two groups.

    Measured: 6 months after the last subject is enrolled

  6. QOL

    According to a questionaire to evaluate the quality of life (QOL) of the two groups.

    Measured: 6 months after the last subject is enrolled

Timeline

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

  1. First posted3 Dec 2019
  2. Study start26 Sep 2017
  3. Primary completionMar 2021 (estimated)
  4. Study completionMar 2021 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Tow arms were design in the study. Group 1: Best Support Care (BSC) Plus K-001. Group 2: BSC Plus Placebo. The participants were assign into two groups in a 2:1.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04183478
Sponsor's protocol ID
CPOG001-05
Status last verified
Nov 2020
First submitted
25 Nov 2019
Last updated
12 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing K-001 in people with Pancreatic Cancer, run by RenJi Hospital at 1 site in China.

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 9 inclusion and 18 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 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 combined 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.

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 Jiujie Cui, MD (86-21-68385559, cuijiujie@126.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: 6 months after the last subject is enrolled). 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 NCT04183478.

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 12 Nov 2020.

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