Chemotherapy-Induced MyelosuppressionPhase 1/2NCT03692780
Careseng 1370 for Chemotherapy-Induced Myelosuppression
A Phase 1/2 study testing Careseng 1370 in people with Chemotherapy-Induced Myelosuppression, run by Careseng Biotech Co., Ltd..
Trial summary
This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chemotherapy-Induced Myelosuppression
- What is being tested?
- Careseng 1370
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Jun 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Of either gender aged at least 20 years old
- Histologically or cytologically confirmed unresectable, locally advanced, metastatic untreated NSCLC and can be accurately assessed by computed tomography/magnetic resonance imaging (CT/MRI) scan (RECIST v1.1) for which regimen of cisplatin + docetaxel is arranged by the investigator; no prior chemotherapy treatment for this disease will be allowed.
- ECOG performance status score ≤2 and life expectancy ≥12 months
- Dated and signed informed consent
Who cannot join
- Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit
- Has undergone major surgery within 4 weeks before Screening visit
- With contraindications to MRI
- Has elective or planned surgery to be conducted during the trial
- Has documented brain or leptomeningeal metastases or any cancer other than NSCLC
- Inadequate hematologic function, as defined by: absolute neutrophil count (ANC) ≤ 1,500/µL; hemoglobin concentration < 10.0 g/dL; and platelet count ≤ 100,000/µL
Show all 30Show fewer
- Inadequate hepatic function, as defined by: total bilirubin level > ULN; AST or ALT > 1.5 x ULN; gamma-GT > 2.5 x ULN; ALP > 2.5 x ULN.
- Inadequate renal function, as defined by: serum creatinine level > 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) < 50 mL/min
- Urinary protein >1+ on dipstick, edema or serum albumin < lower level of normal
- Any other ≥ grade 3 laboratory abnormality at baseline
- Inadequate coagulation function, as defined by: INR > 1.5 x ULN or aPTT > 1.5 x ULN
- Male subject with female spouse/partners who are of childbearing potential refuses to adopt highly effective contraceptives from Screening visit until 7 days after end of study treatment
- Female subjects with childbearing potential who is pregnant (confirmed by urine or serum pregnancy test) or lactating, refuses to adopt highly effective contraceptives, if heterosexually active, from Screening visit until 7 days after end of study treatment
- Requirement of anticoagulants, antiplatelet treatments (e.g., warfarin, heparins) from Screening visit until Final visit
- History of human immunodeficiency virus (HIV) infection
- Has experienced any grade 3 or 4 gastrointestinal bleeding within 12 weeks before Screening visit
- Has a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess <6 months before Screening visit, or the subject has a history of poorly controlled or recurrent inflammatory bowel disease (including Crohn's disease or ulcerative colitis)
- Has participated in a clinical study within 4 weeks prior to Screening visit
- Has a known allergy to investigational product Careseng 1370, matched placebo, cisplatin, docetaxel or their excipients. If there is suspicion that the subject may have an allergy, the subject should be excluded.
- Has known alcohol or drug dependency
- Requirement for ongoing immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine) or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days
- Significant cardiovascular disease, including:
- History of New York Heart Association (NYHA) class III or IV congestive heart failure
- Ongoing uncontrolled hypertension
- History of congenital long QT syndrome
- Ongoing prolonged corrected QT (QTc) interval defined as at least 450 msec
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation)
- Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing per investigator's discretion
- Consumption of herbal preparations/supplements (except for a daily multivitamin/mineral supplement not containing herbal components) within 2 weeks prior to the start of cisplatin + docetaxel or Careseng 1370/matched placebo administration
- Is not considered to be suitable for this study, in the opinion of the investigator
About this study
Official title: A Phase I Dose-Finding Followed by Phase IIa Randomized, Double-Blind, Placebo-Controlled, Parallel, Add-on to Cisplatin Plus Docetaxel Study to Evaluate the Safety, Tolerability and Efficacy Profiles of Careseng 1370 to Treat Chemotherapy-Induced Myelosuppression in Advanced Non-Small Cell Lung Cancer (NSCLC) Subjects
This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.
- Conditions
- Chemotherapy-Induced Myelosuppression
- Being tested
- Careseng 1370, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Careseng 1370Drug
4,000mg granules in sachet
PlaceboDrug
4,000mg granules in sachet
| Study group | Role | What they receive |
|---|---|---|
| Careseng 1370 | Experimental | Not described Receives: Drug: Careseng 1370 |
| Matched Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit
End of Treatment will be Day 85
Measured: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Secondary outcomes (10)
Proportion of subjects with anemia, neutropenia, or thrombocytopenia of all grades at post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in white blood cell (WBC) count from baseline to post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in platelet count from baseline to post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in red blood cell (RBC) count from baseline to post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in serum C-reactive protein (CRP) level from baseline to post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in absolute neutrophil count (ANC) from baseline to post-treatment visits
Measured: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Objective response rate (ORR) defined as the proportion of subjects with CR or PR as best overall response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
Measured: Day 1, 43, 85
Disease control rate (DCR) defined as the proportion of subjects with CR, PR, or SD as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Measured: Day 1, 43, 85
Proportion of subjects with complete response (CR), partial response (PR), stable disease (SD), and progression disease (PD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Measured: Day 1, 43, 85
Change in quality of life assessed by the Functional Assessment of Cancer Therapy Lung Cancer (FACT-L) total score from baseline to post-treatment visits
FACT-L total score ranges from 0 to 144. Higher values represent a worse outcome
Measured: Day 1, 22, 43, 64, 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startMar 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: At sponsor's discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced MyelosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careseng Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692780
- Sponsor's protocol ID
- Careseng 1370-02
- Status last verified
- Dec 2018
- First submitted
- 25 Sep 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Finding Followed by Phase IIa Randomized, Double-Blind, Placebo-Controlled, Parallel, Add-on to Cisplatin Plus Docetaxel Study to Evaluate the Safety, Tolerability and Efficacy Profiles of Careseng 1370 to Treat Chemotherapy-Induced Myelosuppression in Advanced Non-Small Cell Lung Cancer (NSCLC) Subjects
- ClinicalTrials.gov ID
- NCT03692780
- Acronym / sponsor ID
- Careseng 1370-02
- Conditions
- Chemotherapy-Induced Myelosuppression
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At sponsor's discretion
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Careseng Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Careseng 1370 | Experimental | Drug: Careseng 1370 |
| Matched Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Of either gender aged at least 20 years old
- Histologically or cytologically confirmed unresectable, locally advanced, metastatic untreated NSCLC and can be accurately assessed by computed tomography/magnetic resonance imaging (CT/MRI) scan (RECIST v1.1) for which regimen of cisplatin + docetaxel is arranged by the investigator; no prior chemotherapy treatment for this disease will be allowed.
- ECOG performance status score ≤2 and life expectancy ≥12 months
- Dated and signed informed consent
Key exclusion criteria (30 listed)
- Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit
- Has undergone major surgery within 4 weeks before Screening visit
- With contraindications to MRI
- Has elective or planned surgery to be conducted during the trial
- Has documented brain or leptomeningeal metastases or any cancer other than NSCLC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Careseng 13704,000mg granules in sachet | Drug | Careseng 1370 |
| Placebo4,000mg granules in sachet | Drug | Matched Placebo |
Primary outcome
Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit
Time frame: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
End of Treatment will be Day 85
10 secondary outcomes
Proportion of subjects with anemia, neutropenia, or thrombocytopenia of all grades at post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in white blood cell (WBC) count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in platelet count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in red blood cell (RBC) count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in serum C-reactive protein (CRP) level from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in absolute neutrophil count (ANC) from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Objective response rate (ORR) defined as the proportion of subjects with CR or PR as best overall response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
Disease control rate (DCR) defined as the proportion of subjects with CR, PR, or SD as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
Proportion of subjects with complete response (CR), partial response (PR), stable disease (SD), and progression disease (PD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
Change in quality of life assessed by the Functional Assessment of Cancer Therapy Lung Cancer (FACT-L) total score from baseline to post-treatment visits
Time frame: Day 1, 22, 43, 64, 85
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Careseng 1370 in people with Chemotherapy-Induced Myelosuppression, run by Careseng Biotech Co., Ltd..
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 4 inclusion and 30 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: withdrawn, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit (time frame: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2018.