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Pancreatic CancerPhase 1NCT02720666

K-001 Treatment of Advanced Pancreatic Cancer: Clinical Trial of Monotherapy's Tolerability

A Phase 1 study testing K-001 in people with Pancreatic Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

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

This study is an open and single-center Phase I clinical research on patients with advanced pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to determine the safe and reasonable dosage and dosing regimen. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
K-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2016
Phase
Phase 1
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease-related criteria for inclusion:
  • Based on histodiagnosis or cytodiagnosis;
  • Locally advanced or metastatic pancreatic adenocarcinoma;
  • Failure of standard treatment, >28 days after the last chemotherapy;
  • Patients not suitable for or having given up standard treatment;
  • At least one lesion measurable according to RECIST V 1.0 criteria;
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  • ECOG score: 0～1;
  • Expected survival: ≥3 months;
  • Haematological, biochemical and organ functions:
  • Hematological indices:
  • Absolute neutrophil count: ≥1.5×109/L;
  • Platelet count: ≥80×109/L;
  • Hemoglobin: ≥9.0 g/dL.
  • Total bilirubin: ≤1.5 x ULN, albumin: ≥3.0g/dL;
  • Patients without liver metastasis: ALT (SGPT) \& AST (SGOT) ≤3.0 x ULN Patients with liver metastasis: ALT (SGPT) \& AST (SGOT)≤5.0 x ULN;
  • Renal functions: serum creatinine ≤ 1.5xULN, Ccr ≥ 60ml/min (Cockcroft-Gault);
  • General criteria for inclusion:
  • Age: 18～70;
  • Letter of Consent signed by the patient or his/her legal representative:
  • Women of childbearing age must have a urine pregnancy test within 7 days before starting treatment, only negative results shall be included in the group. Male and female patients of childbearing age have agreed to use a reliable method of contraception before and during participating the study as well as 90 days (at least) after withdrawal.

Who cannot join

  • Disease-related criteria for exclusion:
  • Patients of pancreatic tumor but not adenocarcinoma;
  • Having received radiotherapy for his/her target lesions prior to this study, with no progress;
  • Known presence of brain metastases or leptomeningeal metastases;
  • With Vater's ampulla cancer or bile duct cancer;
  • Partial or complete intestinal obstruction;
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  • History of other malignancies in past five years, except for:
  • A consecutive 5-year disease-free survival from single surgery of other malignancies;
  • Cured basal cell carcinoma and cured cervical carcinoma in situ.
  • General criteria for exclusion:
  • Pregnant or breast-feeding women;
  • Any unstable systemic disease, including: active infection; hypertension uncontrollable by medication (≥160/100mmHg); unstable angina, or angina with the onset from within the last three months; congestive heart failure (≥level II according to New York Heart Association [NYHA], see Annex 4); myocardial infarction occurred within 1 year before the enrollment; severe arrhythmias requiring medical treatment; and mental disorders, etc.;
  • Presence of active hepatitis B (history of hepatitis B infection, whether with or without medication, HBV DNA≥104 copy number or ≥2000u/ml) or HCV-Ab positive; known HIV-positive patients (no clinical signs or symptoms suggesting exemption of HIV test for HIV-infected individuals);
  • Having received any of the following treatment within specific time period before inclusion:
  • Having had a major surgery within 4 weeks before inclusion;
  • Having received expanded scope of radiotherapy within 4 weeks, or having received limited scope of radiotherapy within 2 weeks before inclusion;
  • Having participated in any other therapeutic/interventive clinical trials within 4 weeks before inclusion, or taking part in an ongoing trial.
  • With CTCAE toxicity at level II or above (excluding hair loss or skin pigmentation), uncured and caused by any previous treatment;
  • Not fitting in the study, as conceived by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: K-001 Treatment of Advanced Pancreatic Cancer: Phase I Clinical Trial of Monotherapy's Tolerability

This study is an open and single-center Phase I clinical research on patients with advanced pancreatic cancer, for evaluating their adverse reactions or tolerance to K-001, so as to determine the safe and reasonable dosage and dosing regimen.

Read the detailed description

According to past experience to toxicology studies and clinical test, K-001 at a dose of 2700mg/day has a good safety profile for human body. Upon observation, pancreatic cancer patients receiving a medication at 2160mg/day (1080mg BID) have had good therapeutic efficacy, no sign of significant toxicity.

Dosing regimen:

Phase I clinical test: maximum dose of monotherapy at 2700mg/day. Four groups of repeated administration of monotherapy, at least 3 patients for each group.

Group A: 2700mg/d (1350mg BID); Group B: 3240mg/d (1620mg BID); Group C: 3780mg/d (1890mg BID); Group D: 4320mg/d (2160mg BID). Twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.

In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.

Being tested
K-001
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

    Also called Peptidoglycan Complex of Spirulina

    In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.

Study groups in NCT02720666
Study groupRoleWhat they receive
Group A:K-001 2700mg/d (1350mg BID)ExperimentalK-001 1350mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
Receives: Drug: K-001
Group B: K-001 3240mg/d (1620mg BID)ExperimentalK-001 1620mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
Receives: Drug: K-001
Group C: K-001 3780mg/d (1890mg BID)ExperimentalK-001 1890mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
Receives: Drug: K-001
Group D: K-001 4320mg/d (2160mg BID)ExperimentalK-001 2160mg twice a day, to be taken with warm water on an empty stomach; 4 weeks' administration for each group.
Receives: Drug: K-001

What is being measured

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

  1. The maximum-tolerated dose (MTD) of K-001

    The maximum-tolerated dose (MTD) of K-001 will be defined as the maximum dose level at which no more than one patient out of three experiences a dose-limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 4.0. If none of the patient experiences DLT, the maximum dose in the trial (4320mg/d) will be defined as MTD and the biologically effective dose.

    Measured: day 29

Secondary outcomes (5)

  1. Change of life quality assessed using EORTC QLQ-C30 V 3.0

    EORTC QLQ-C30 V 3.0

    Measured: within 7 days before taking drugs and day 8, day 15, day 22 and day 29

  2. Change from Baseline of the Treg cell count

    Laboratory tests: blood immunity test of FOXP3+CD4+Treg cell count

    Measured: within 14 days before taking drugs, day 15 and day 29

  3. Evaluation of suffered pains assessed using Numerical Rating Scale (NRS)

    Numerical Rating Scale (NRS)

    Measured: within 7 days before taking drugs and day 8, day 15, day 22 and day 29

  4. Change from Baseline of the C-reactive protein (CRP)

    Evaluation the level of CRP with laboratory tests of blood.

    Measured: within 14 days before taking drugs, day 15 and day 29

  5. Clinical efficacy of K-001 assessed by disease control rate (DCR) according to RECIST V 1.0 criteria

    Evaluate patients with imaging, including CT/MRI of the chest, abdomen and pelvic, and get disease control rate (DCR) according to RECIST V 1.0 criteria.

    Measured: day 29

Timeline

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

  1. First posted28 Mar 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02720666
Sponsor's protocol ID
CPOG001_01
Status last verified
Jan 2017
First submitted
13 Feb 2016
Last updated
6 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Cui J, Yang H, Liu J, Chen D, Hu J, Zhang H, Wang Y, Han T, Mao T, Jiao F, Biskup E, Pan Y, Liu M, Wang L. A phase I study of the safety and activity of K-001 in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2021 Jun 7;21(1):672. doi: 10.1186/s12885-021-08375-6.

    PubMed 34098895

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing K-001 in people with Pancreatic Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 20 inclusion and 19 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 6 Jan 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The maximum-tolerated dose (MTD) of K-001 (time frame: day 29). 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 NCT02720666, 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 6 Jan 2017.

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