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Chronic Lymphocytic Leukemia (CLL)Phase 1NCT03588598

Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies

A Phase 1 study testing SHC014748M in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SHC014748M in patients with relapsed or refractory indolent B-cell hematologic malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
SHC014748M
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
7 Sep 2018to Dec 2019
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.18- 75 years of age.
  • 2.Histologically or cytologically confirmed diagnosis of relapsed or refractory indolent B-cell hematologic malignancies, including but not limited to CLL / SLL, FL (grade 1, 2 or 3a), or MZL.
  • 3.Patients have received at least 1 prior regimen (at least 2 cycles).
  • 4.Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
  • 5.Life expectancy ≥ 3 months.
  • 6.Patients have at least 1 measurable lesion that measures ≥1.5 cm in a single dimension as assessed by CT or MRI.
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  • 7.Adequate organ function, as defined by the following values: ANC≥1.0×10^9/L； PLT≥50×10^9/L； Hb≥80 g/L； TBIL≤1.5×ULN； ALT and AST≤2.5×ULN； BUN and Cr≤1.5×ULN； LVEF≥50%； QTcF <450 ms for male, QTcF <470 ms for female；
  • 8.Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
  • 9.Subjects did not participate in other clinical trials within 3 months prior to study entry.

Who cannot join

  • Disease progression after previous treatment with any PI3Kδ inhibitors.
  • Had any other anti-tumor treatment within 4 weeks prior to screening (including radiotherapy, chemotherapy, hormone therapy, surgery or targeted therapy).
  • Evidence of central nervous system involvement of the malignancy.
  • Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, non-infectious pneumonia, and any other severe cardiovascular, respiratory, nervous and mental diseases.
  • Any of the severe heart diseases, including New York Heart Association (NYHA) Class II or greater heart failure, arrhythmias requiring medical treatment, and history of myocardial infarction or unstable angina within 6 months prior to screening.
  • Require any concomitant medication known to prolong the QT interval during the study.
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  • Evidence of active bacterial, fungal, or viral infection.
  • Active infection with hepatitis B virus (HBV) (HBsAg positive, or HBsAg negative and HBV-DNA positive), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  • Use of high-dose glucocorticoids (eg, ≥20 mg/day prednisone) or other immunosuppressants within 4 weeks prior to study entry.
  • Concomitant use of any strong inhibitors or inducers of CYP3A4.
  • Use of G-CSF or blood transfusion within 7 days before the hematology test at screening.
  • Prior autologous hematopoietic stem cell transplantation within 6 months prior to treatment initiation.
  • History of prior allogeneic hematopoietic stem cell transplantation.
  • Major surgery within 4 weeks prior to treatment initiation.
  • History of a non-lymphoma malignancy in the past five years except for the following: adequately treated cervical carcinoma in situ, local basal cell or squamous cell carcinoma of the skin.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the drug or previous significant bowel resection that would preclude adequate absorption of the study drug.
  • History of hypersensitivity to drugs similar to the study drug or inactive excipients of the study drug.
  • Women who are breastfeeding.

Trial locations and contacts

2 sites in 1 country.

Wei Guo contact

+86025-81066427

guoweiyf@sanhome.com

Xiaodan Lyu contact

+86025-81066469

lvxd@sanhome.com

China2 sites, 2 recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

    Jie Jin, MD

    Recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu, 210029

    Jianyong Li, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase I Dose Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Relapsed or Refractory Indolent B-Cell Hematologic Malignancies.

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of SHC014748M in patients with relapsed or refractory indolent B-cell hematologic malignancies.

Read the detailed description

This is a phase I, sequential dose escalation followed by cohort expansion study of SHC014748M, an oral inhibitor of PI3K delta, in patients with relapsed or refractory indolent B-cell hematologic malignancies.

Being tested
SHC014748M
Keywords
CLL, SLL, NHL, SHC014748M, Phosphatidylinositol 3-kinase (PI3K)
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.

  • SHC014748MDrug

    a selective PI3Kδ inhibitor

Study groups in NCT03588598
Study groupRoleWhat they receive
SHC014748M treatmentExperimentalSHC014748M capsule， 50, 100, 150, 200, 250 mg, QD, 28 days for each cycle
Receives: Drug: SHC014748M

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    Measured: 1 month

  2. Time to Peak Plasma Concentration（Tmax）

    Measured: 1 month

  3. Peak Plasma Concentration (Cmax)

    Measured: 1 month

  4. Half-life Time(t1/2)

    Measured: 1 month

  5. Area Under the Plasma Concentration Versus Time Curve (AUC)

    Measured: 1 month

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Measured: up to 12 months

  2. Lymph Node Response (LNR)

    Measured: up to 12 months

  3. Time to Response (TTR)

    Measured: up to 12 months

  4. Progression-Free Survival (PFS)

    Measured: up to 12 months

  5. Duration of Response (DOR)

    Measured: up to 12 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 Jul 2018
  2. Study start7 Sep 2018
  3. Primary completionJul 2019 (estimated)
  4. Study completionDec 2019 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03588598
Sponsor's protocol ID
SHC014-I-01
Status last verified
Apr 2019
First submitted
28 Jun 2018
Last updated
30 Apr 2019
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 SHC014748M in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 2 sites 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Wei Guo (+86025-81066427, guoweiyf@sanhome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 1 month). The study lists 5 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 NCT03588598.

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 30 Apr 2019.

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