Careseng 1370 for Chemotherapy-Induced Myelosuppression

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

March 2019

Estimated Primary Completion Date

March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]
FACT-L total score ranges from 0 to 144. Higher values represent a worse outcome

Descriptive Information

Brief Title ^ICMJE

Careseng 1370 for Chemotherapy-Induced Myelosuppression

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1/Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Careseng 1370
4,000mg granules in sachet
Drug: Placebo
4,000mg granules in sachet

Study Arms

Experimental: Careseng 1370
Placebo Comparator: Matched Placebo

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2021

Estimated Primary Completion Date

March 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. Of either gender aged at least 20 years old 2. 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. 3. ECOG performance status score ≤2 and life expectancy ≥12 months 4. Dated and signed informed consent Exclusion Criteria: 1. Had chemotherapy, therapeutic radiotherapy, or other therapy for NSCLC within 6 weeks before Screening visit 2. Has undergone major surgery within 4 weeks before Screening visit 3. With contraindications to MRI 4. Has elective or planned surgery to be conducted during the trial 5. Has documented brain or leptomeningeal metastases or any cancer other than NSCLC 6. 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 7. 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. 8. Inadequate renal function, as defined by: serum creatinine level > 1.5 x ULN; or calculated serum creatinine clearance (Cockcroft-Gault) < 50 mL/min 9. Urinary protein >1+ on dipstick, edema or serum albumin < lower level of normal 10. Any other ≥ grade 3 laboratory abnormality at baseline 11. Inadequate coagulation function, as defined by: INR > 1.5 x ULN or aPTT > 1.5 x ULN 12. 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 13. 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 14. Requirement of anticoagulants, antiplatelet treatments (e.g., warfarin, heparins) from Screening visit until Final visit 15. History of human immunodeficiency virus (HIV) infection 16. Has experienced any grade 3 or 4 gastrointestinal bleeding within 12 weeks before Screening visit 17. 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) 18. Has participated in a clinical study within 4 weeks prior to Screening visit 19. 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. 20. Has known alcohol or drug dependency 21. 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 22. Significant cardiovascular disease, including: 1. History of New York Heart Association (NYHA) class III or IV congestive heart failure 2. Ongoing uncontrolled hypertension 3. History of congenital long QT syndrome 4. Ongoing prolonged corrected QT (QTc) interval defined as at least 450 msec 5. History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) 23. Uncontrolled psychiatric disorder or altered mental status precluding informed consent or necessary testing per investigator's discretion 24. 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 25. Is not considered to be suitable for this study, in the opinion of the investigator

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

，

Study Sponsor ^ICMJE

Careseng Biotech Co., Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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