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Small Cell Lung CancerPhase 2NCT04501029

A Study of Gimatecan (ST1481) in Small Cell Lung Cancer

A Phase 2 study testing Gimatecan in people with Small Cell Lung Cancer, run by Lee's Pharmaceutical Limited 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 The sponsor has not verified this record for over two years, so it may be out of date.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 phase Ib/II clinical trial studies the safety and effect of Gimatecan in small cell lung cancer patients who failed the first-line standard platinum-containing chemotherapy. The chemotherapy will be given every four weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Gimatecan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
1 Oct 2020to 1 Oct 2023
Phase
Phase 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years old of either gender;
  • A histopathological or cytological diagnosis of small cell lung cancer(SCLC);
  • Recurrence or progression disease after firstline platinum-containing chemotherapy and patients intolerant or unwilling to receive standard treatment;
  • Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  • Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
  • Estimated life expectancy >4 months;
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  • Taking drugs orally;
  • The function of important organs meets the following requirements:
  • white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
  • ALT, AST and AKP ≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN, ALP ≤ 6.0×ULN; bone metastases ALT、AST≤ 2.5×ULN, ALP ≤ 5.0×ULN;
  • serum albumin ≥ 30g/L;
  • total bilirubin ≤ 1.5×ULN;
  • serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
  • INR ≤ 1.5, PT≤ 1.5×ULN;
  • 10. Serum HCG negative in premenopausal women, female patients of childbearing potential and male patients with female partners of childbearing potential must be willing to avoid pregnancy; 11. Ability to understand the study and sign informed consent.

Who cannot join

  • Patients who have been treated previously for SCLC with two system chemotherapy (except for targeted therapy, immunotherapy and antiangiogenic therapy);
  • Patients who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
  • Known or suspected allergy or hypersensitivity to the investigational drug gimatecan ingredients or their analogues;
  • Other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug gimatecan;
  • Patients who have been treated previously with intravenous or oral drugs that affect CYP isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan;
  • Brain metastasis or meningeal metastasis (except for asymptomatic patients with lesion stable more than 28 days);
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  • Major surgical intervention or trauma within 28 days prior to the first dose of investigational drug administration;
  • A history of gastrointestinal disease which affects drug absorption;
  • A history of allogeneic stem cell transplantation and organ transplantation;
  • A history of interstitial lung disease or non-infectious pneumonia;
  • Patients who cannot tolerate chemotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
  • A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
  • Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
  • A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
  • A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
  • Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

LIU XIAOQING, MD contact

86-010-66947797

liuxiaoqing@csco.org.cn

China1 site

  • The Fifth Medical Center of General Hospital of the Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100071

    LIU XIAOQING, MD, 86-010-66947797

Other trials in China

About this study

Official title: A Phase Ib/II Study of Gimatecan (ST1481) for Small Cell Lung Cancer Patients Who Failed Standard Platinum-containing Chemotherapy

This phase Ib/II clinical trial studies the safety and effect of Gimatecan in small cell lung cancer patients who failed the first-line standard platinum-containing chemotherapy. The chemotherapy will be given every four weeks.

Being tested
Gimatecan
Keywords
small cell lung cancer, chemotherapy, gimatecan
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • GimatecanDrug

    Also called ST1481

    Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.

Study groups in NCT04501029
Study groupRoleWhat they receive
Gimatecan groupExperimentalIn Phase Ib study, patients will receive gimatecan at different dose level (0.4mg/m2, 0.6mg/m2,0.8mg/m2, oral, every 4 weeks) until progressive disease (PD).In Phase II study, patients will receive gimatecan at recommended phase II dose level.
Receives: Drug: Gimatecan

What is being measured

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

  1. Dose limited toxicity (DLT)

    Phase Ib: Number of patients experienced any dose limited toxicity over the DLT period.

    Measured: up to 28 days.

  2. Recommended phase II dose (RP2D)

    Phase Ib: Determination of recommended phase II dose of escalating dose of gimatecan for the phase II part of the study.

    Measured: up to 12 months.

  3. Objective response rate (ORR)

    Percentage of patients with objective response assessed by best overall response (BOR) of either complete response(CR) or partial remission(PR) will be reported.

    Measured: To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.

Secondary outcomes (6)

  1. Progression free survival (PFS)

    The 2-year progression free survival of the whole group.

    Measured: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.

  2. Disease control rate (DCR)

    Percentage of patients with disease control as assessed by best overall response (BOR) of either complete response(CR), partial remission(PR) or stable disease (SD) will be reported.

    Measured: To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.

  3. Duration of Response (DoR)

    The DoR applies only to patients whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).

    Measured: First documented CR or PR, whichever is first recorded until the first assessment of PD, assessed up to 24 months.

  4. Overall survival (OS)

    The 2-year overall survival of the whole group.

    Measured: From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.

  5. Survival rate (SR)

    Survival probability of patients calculated according to Kaplan-Meier curve at either 1 or 2 year.

    Measured: up to 24 months.

  6. Treatment related adverse events rate

    The incidence rate of treatment related adverse events of the whole group assessed by CTCAE v5.0.

    Measured: From the enrollment to 30 days later of the last chemotherapy.

Timeline

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

  1. First posted6 Aug 2020
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion1 Oct 2023 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04501029
Sponsor's protocol ID
ST1481-LEES-2020-03
Status last verified
Jul 2020
First submitted
30 Jul 2020
Last updated
6 Aug 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hurwitz JL, McCoy F, Scullin P, Fennell DA. New advances in the second-line treatment of small cell lung cancer. Oncologist. 2009 Oct;14(10):986-94. doi: 10.1634/theoncologist.2009-0026. Epub 2009 Oct 9.

    PubMed 19819917

  • Owonikoko TK, Behera M, Chen Z, Bhimani C, Curran WJ, Khuri FR, Ramalingam SS. A systematic analysis of efficacy of second-line chemotherapy in sensitive and refractory small-cell lung cancer. J Thorac Oncol. 2012 May;7(5):866-72. doi: 10.1097/JTO.0b013e31824c7f4b.

    PubMed 22722788

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gimatecan in people with Small Cell Lung Cancer, run by Lee's Pharmaceutical Limited 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 15 inclusion and 16 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 6 Aug 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. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact LIU XIAOQING, MD (86-010-66947797, liuxiaoqing@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limited toxicity (DLT) (time frame: up to 28 days.). The study lists 3 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 NCT04501029, which also lists 2 linked publications.

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 Aug 2020.

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