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Chronic Lymphocytic LeukemiaPhase 1NCT04682808

A Study of FCN-338 in Patients With Chronic CLL/SLL

A Phase 1 study testing FCN-338 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Fochon Pharmaceuticals, Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is being done to evaluate the Tolerability、Pharmacokinetics and Preliminary antitumor activity of oral FCN-338 for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have failed or are intolerant to one or more lines of established therapy or for whom… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FCN-338
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteChina
Study dates
13 May 2021to 31 Dec 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years，no gender limitation；
  • According to the 2018 iwCLL guidelines ，diagnosed as chronic lymphocytic leukemia or small cell lymphoma;
  • Refractory or recurrent CLL/SLL having previously received at least first-line systemic treatment. First-line treatment is defined as the completion of at least 2 cycles of a standard protocol or clinical trial based on current guidelines. Medical record of disease progression after the last treatment failed or remission. According to the 2018 iwCLL guidelines, there are at least one CLL/SLL indications that require treatment. [Refractory definition: treatment failure (without PR) or PD < 6 months after the last chemotherapy); Definition of recurrence: Patients with complete response (CR) or partial response (PR) ≥ 6 months after disease progression (PD)];
  • ECOG Performance Status scored ≤ 1 （Dose Escalation Stage）or ≤ 2（Dose Expansion Stage）；
  • The expected survival is at least 3 months;
  • Adequate hematologic、renal function parameters；
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  • If patient have a high risk of developing TLS, The absolute lymphocyte count was ≥ 25× 109/L and there was a lymph node with a maximum diameter ≥ 5 cm assessed by radiology or there was a node with a maximum diameter ≥ 10 cm assessed by radiology ，patient must deal with TLS according to the protocol；
  • For fertile patients: the patient shall consent to effective contraception during the treatment period and for at least 90 days after the last administration of the study treatment, and to receive contraceptive methods such as double-screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices. Male patients should agree to avoid sperm donation;
  • Patients voluntarily signed informed consent;

Who cannot join

  • The patient's prior antitumor therapy meets one of the following criteria:
  • Use of other cytotoxic drugs, research drugs or other antitumor drugs within 14 days or 5 half-lives before first receiving study drugs;
  • Major surgery was performed within 4 weeks prior to the first receiving study drug or had not fully recovered from previous surgery；
  • Systemic radiotherapy was performed within 28 days prior to the first dose of the study drug, or non-hematological toxicity has not recovered from previous radiotherapy to NCI-CTCAE (version 5.0) level 0-1;
  • Received anti-tumor monoclonal antibody therapy within 4 weeks before receiving the first study drug;
  • The toxicity of previous antitumor therapy has not recovered (≥ NCI-CTCAE [version 5.0] level 2), except for hair loss;
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  • Received steroid therapy for antitumor within 7 days before first receiving study drug;
  • Has received allogeneic stem cell transplantation or autologous stem cell transplantation within 6 months prior to first receiving research drug；
  • The biopsy confirmed the transformation to Richter's syndrome；
  • Drug resistance to another bcl-2 family protein inhibitor has occurred (for extend study use only)；
  • Cardiac function and disease meet one of the following conditions:
  • The prolonged QTc interval has clinical significance, or the screening stage QTc interval is >470ms for women or >450ms for men；
  • American New York Heart Association (NYHA) grade ≥ 2 congestive Heart failure;
  • Unstable angina, myocardial infarction, or arrhythmia requiring treatment during screening, Left ventricular ejection fraction (LVEF) <50%; Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmia-causing right ventricular cardiomyopathy, restricted cardiomyopathy, unformed cardiomyopathy);
  • The investigators determined that the patient's cardiac function can't tolerate to TLS prophylaxis；
  • Patients who have a history of significant renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immunological, cardiovascular or liver diseases that the investigator believes may adversely affect Patients participation in the study；
  • Allergy to the same kind of drugs and excipients used in research；
  • A woman who is pregnant or nursing；
  • Except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancies that have been controlled and surgically removed or treated with radical treatment, a history of other active malignancies except for CLL/SLL Within 3 years of the start of the study；
  • Difficulty swallowing, or having malabsorption syndrome or other medical conditions that prevent the absorption of drugs through the intestine；
  • Exhibit other clinically significant uncontrolled conditions, including but not limited to:
  • Uncontrollable systemic infections (viruses, bacteria, fungi) include viral Hepatitis B (Hepatitis B surface antibody-positive with DNA exceeding 1000 CPS/mL or 1000 IU/ml, or Hepatitis C Virus (HCV) RNA positive)；
  • An active and uncontrolled autoimmune hemocytopenia lasting 2 weeks or longer, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura；
  • Systemic diseases that affect patients adherence to study participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • SUN YAT-University Cancer Center

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Phase I Trial to Evaluate the Tolerability、Pharmacokinetics and Preliminary Antitumor Activity of FCN-338 in Patients With CLL/SLL

This study is being done to evaluate the Tolerability、Pharmacokinetics and Preliminary antitumor activity of oral FCN-338 for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have failed or are intolerant to one or more lines of established therapy or for whom no other treatment options are available.

Read the detailed description

This is a multicenter, open-label, Phase I dose escalation study of Tolerability、Pharmacokinetics and Preliminary antitumor activity of FCN-338 in ascending cohorts to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.

Being tested
FCN-338
Keywords
BCL-2, CLL, SLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • FCN-338Drug

    FCN-338 will be given orally in ascending doses starting at 50 mg QD until the maximum tolerated dose or recommended dose is reached.

Study groups in NCT04682808
Study groupRoleWhat they receive
Dose Escalation and ExpansionExperimentalFCN-338 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL , until the maximum tolerated dose or recommended dose is reached. Followed by up to 43 patients enrolled in the expansion cohort at the recommended dose.
Receives: Drug: FCN-338

What is being measured

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

  1. The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)

    Measured: Cycle 1 (28 days)

  2. To establish the recommended MTD dose and Phase 2 dose (RP2D) of FCN-338 for future clinical trials in patients with advanced CLL/SLL

    Measured: Up to 24 months

  3. The occurrence of adverse events (AEs) reported in all subjects who received study drug

    Measured: From enrollment up to 30 days after last dose

  4. The occurrence of treatment-emergent adverse events (TEAs)

    Measured: From first dose up to 30 days after last dose

Secondary outcomes (7)

  1. Pharmacokinetic variables including maximum plasma concentration (Cmax)

    Measured: Cycle 1 (28 days)

  2. Pharmacokinetic variables including minimum plasma concentration (Cmin)

    Measured: Cycle 1 (28 days)

  3. To quantify the last time point with a quantifiable concentration (AUClast) of FCN-338

    Measured: Cycle 1 (28 days)

  4. To measure the time to reach the highest plasma concentrations (Tmax) of FCN-338

    Measured: Cycle 1 (28 days)

  5. To quantify the terminal half-life (T1/2) of FCN-338 after administration as a single agent

    Measured: Cycle 1 (28 days)

  6. To quantify the plasma clearance (CL/f) of FCN-338 after administration as a single agent

    Measured: Cycle 1 (28 days)

  7. To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with Chronic CLL/SLL

    Measured: Measured up to 2 years after the last participant has enrolled in the study

Timeline

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

  1. First posted24 Dec 2020
  2. Study start13 May 2021
  3. Primary completion28 Apr 2024
  4. Study completion31 Dec 2024 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682808
Sponsor's protocol ID
FCN-338-002
Status last verified
Aug 2024
First submitted
10 Dec 2020
Last updated
13 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FCN-338 in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Fochon Pharmaceuticals, Ltd. 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 24 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 13 Aug 2024. 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?

Results are not available in the source record.

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 occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 4 primary outcomes in all. 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 NCT04682808.

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 13 Aug 2024.

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