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Non-hodgkin's LymphomaPhase 1/2NCT03974243

Chiauranib in Combination With Chidamide in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

A Phase 1/2 study testing Chiauranib and Chidamide in people with Non-hodgkin's Lymphoma, run by Chipscreen Biosciences, Ltd. 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

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib and Chidamide administered orally over a range of doses in patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the pharmacodynamic profile and latent biomarkers accompany… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-hodgkin's Lymphoma
What is being tested?
Chiauranib and Chidamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
11 Jul 2019to 31 Dec 2021
Phase
Phase 1/2
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female, aged ≥ 18 yrs and ≤70 yrs;
  • Patients with NHL refractory to at least 2 different chemotherapies , for which no standard therapy exists;
  • At least 1 lesion can be accurately measured, as defined by Lugano 2014 criteria.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Subjects received anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy and surgical therapy, et al) should beyond 4 weeks prior to study entry; Subjects received mitomycin chemotherapy should beyond 6 weeks prior to study entry; Subjects received autologous stem cell transplantation should beyond 3 months prior to study entry;
  • Laboratory criteria are as follows:
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  • Complete blood count: hemoglobin (Hb) ≥90g/L ; absolute neutrophil count (ANC) ≥1.5×109/L ; platelets >=90×109/L Biochemistry test: total bilirubin≦1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≦1.5×ULN; (ALT,AST≦5×ULN if liver involved) ;serum creatinine(cr)≦1.5×ULN; Coagulation test: International Normalized Ratio (INR) < 1.5
  • Life expectancy of at least 3 months.
  • Willingness to sign a written informed consent document.

Who cannot join

  • Clinical evidence of central nervous system involvement
  • Patients with prior invasive malignancies with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, unless received curative treatment and with documented evidence of no recurrence in the past five years;
  • Previous treatment with HDAC inhibitors(include Chidamide) or aurora kinase(include Chiauranib) inhibitors;
  • Have uncontrolled or significant cardiovascular disease, including:
  • Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) < 50% requiring treatment with agents during screening stage.
  • primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)
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  • History of significant QT interval prolongation, or Corrected QT Interval (QTc) > 450 ms prior to study entry
  • Symptomatic coronary heart disease requiring treatment with agents
  • Uncontrolled hypertension (> 140/90 mmHg) by single agent;
  • Have active bleeding current thrombotic disease, patients with bleeding potential ,or receiving anticoagulation therapy; within 2 months prior to screening;
  • Proteinuria positive(≥1g/24h);
  • History of deep vein thrombosis or pulmonary embolism;
  • Have unsolved toxicities (> grade 1) from prior anti-cancer therapy;
  • Have clinical significant gastrointestinal abnormality, e.g., unable to swallow, chronic diarrhea, ileus, that would impair the ingestion,transportation or absorption of oral agents, or patients undergone gastrectomy;
  • History of organ transplantation ，Allogeneic bone marrow transplantation or autologous stem cell transplantation;
  • High-risk surgery for vital organs within 6 weeks prior to screening or the investigators determined that other surgical wounds did not heal well;
  • Serologically positive for HIV, hepatitis B or C, or other serious infectious diseases;
  • History of interstitial lung disease(ILD);
  • Any mental or cognitive disorder, that would impair the ability to understand the informed consent document or the operation and compliance of study;
  • Candidate with drug and alcohol abuse;
  • Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy);
  • Any other condition which is inappropriate for the study in the opinion of the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Phase Ib/IIa Study of Chiauranib in Combination With Chidamide in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chiauranib and Chidamide administered orally over a range of doses in patients with relapsed or refractory non-Hodgkin's lymphoma, in the meantime, exploring the pharmacodynamic profile and latent biomarkers accompany with Chiauranib and Chidamide , as well as the relevancy of which and clinical benefit.

Read the detailed description

The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests ,etc., of a range of doses of Chiauranib and Chidamide in patients with relapsed or refractory non-Hodgkin's lymphoma, and to determine the dose limit toxicity and the maximum tolerable dose.

In the meantime, exploring the pharmacodynamic profile and latent biomarkers accompany with Chiauranib and Chidamide , as well as the relevancy of which and clinical benefit.

Being tested
Chiauranib, Chidamide
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • ChiauranibDrug

    Also called CS2164

    In the lead-in period, patients take 50mg Chiauranib capsules on the forth day .

    In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle.

  • ChidamideDrug

    Also called CS055

    In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8,11,15,18,22 and 25 of each cycle. 28 days as a cycle

Study groups in NCT03974243
Study groupRoleWhat they receive
treatment groupExperimentalIn this arm, patients would be given the regimen composed of Chiauranib and Chidamide orally. Intervention: Drug: Chiauranib and Chidamide
Receives: Drug: Chiauranib; Drug: Chidamide

What is being measured

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

  1. dose-limiting toxicity (DLT)

    Measured: Day 1 - 28

Secondary outcomes (12)

  1. Area under the concentration versus time curve (AUC)

    pharmacokinetic profile of Chiauranib in combination with Chidamide

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

  2. Peak plasma concentration (Cmax)

    pharmacokinetic profile of Chiauranib in combination with Chidamide

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

  3. Time of Cmax (Tmax)

    pharmacokinetic profile of Chiauranib in combination with Chidamide

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

  4. Objective response rate

    Measured: About 21 weeks

  5. complete response rate

    Measured: About 21 weeks

  6. disease control rate

    Measured: About 21 weeks

  7. time to progression

    duration from date of treatment until the date of first documented progression

    Measured: About 21 weeks

  8. Progression free survival

    From date of treatment until the date of first documented progression or date of death from any cause, whichever came first

    Measured: About 21 weeks

  9. Duration of response

    From the first date of response until the date of first documented progression

    Measured: About 21 weeks

  10. Adverse events

    Number of participants with treatment-related adverse events according to CTCAE V4.03

    Measured: About 21 weeks

  11. Any single mutation of oncogene and copy number variation in ctDNA(single gene analysis)

    Measured: day -1 of therapy

  12. Mutation of polygene and copy number variation in signal pathway(multi-gene analysis)

    Measured: day -1 of therapy

Timeline

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

  1. First posted4 Jun 2019
  2. Study start11 Jul 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974243
Sponsor's protocol ID
CAR106
Status last verified
Aug 2021
First submitted
30 May 2019
Last updated
9 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Chiauranib and Chidamide in people with Non-hodgkin's Lymphoma, run by Chipscreen Biosciences, 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 22 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 9 Mar 2022. 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 combined 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.

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?

dose-limiting toxicity (DLT) (time frame: Day 1 - 28). 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 NCT03974243.

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 9 Mar 2022.

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