NSCLC Stage IV Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel, Pilot Study to Evaluate the Quality of Life Improvement of Oral Oligo Fucoidan as an Adjuvant in Subjects Receiving Platinum-based Chemotherapy With NSCLC
Verified date | August 2019 |
Source | Hi-Q Marine Biotech International, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary Objectives:
To evaluate the Quality of Life (QoL) score of adding oral Oligo Fucoidan to platinum-based
chemotherapy in comparison with placebo in subjects with Non-Small Cell Lung Cancer (NSCLC).
Secondary Objectives:
To assess the progression-free survival (PFS) and objective response rate (ORR) of adding
oral Oligo Fucoidan to platinum-based chemotherapy in comparison with placebo in subjects
with NSCLC.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 30, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Male or female subjects must be = 20 years of age, inclusive, at time of screening. - Life expectancy > 12 weeks. - Subject must have cytologically or histologically confirmed NSCLC. Subjects with mixed histology tumors will be eligible. If cytology is used for diagnosis, the sample must be unequivocally NSCLC. - Subject has Stage III or IV NSCLC disease at the time of screening. - Subject is not amenable to surgical resection or radiation with curative intent and have not received chemotherapy for their NSCLC, no matter it is new diagnosis or relapse. - Subject is planned to receive triweekly platinum-based chemotherapy regimen prior to randomization. (Platinum dose for cisplatin is 51~80 mg/m2, or carboplatin at AUC 4~6) - Subject must have at least 1 measurable tumor lesion, not previously irradiated, as defined by RECIST (version 1.1). - Subject must have no history of brain metastases or evidence of CNS tumors at screening assessment.. - Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2. - Subject must be able to take oral medication. - Subject must have adequate bone marrow, renal and hepatic function as follows: - Absolute neutrophil count (ANC) = 1,500/mm3 (1.5 × 109/L); - Platelets = 100,000/mm3 (100 × 109/L); - Hemoglobin = 9.0 g/dL (5.6 mmol/L); - Serum creatinine concentration within the normal range (according to the standard value of each hospital); - Hepatic function: AST and ALT = 2.5 times upper limit of normal unless liver metastases are present, then AST and ALT < 5.0 times upper limit of normal; bilirubin = 1.5 times upper limit of normal (subjects with Gilbert's Syndrome may have a bilirubin = 3.0 times upper limit of normal). - Female and male patients of childbearing potential and at the risk of pregnancy must agree to use at least one of highly effective contraception method throughout the study. - Subject must be capable of understanding and complying with parameters as outlined in the protocol and able to sign inform consent. Exclusion Criteria: - Subject has a known hypersensitivity to Fucoidan, platinum compounds and all other drug component of current chemotherapy. - Subject has peripheral neuropathy = grade 2. - Subject has a history of seizure within 12 months prior to study entry. - Subject has received more or equal to third-line biomarker-targeted therapy. - Subject has received herbal remedies for cancer treatment, non-prescription anti-cancer supplements for cancer treatment, or traditional Chinese medicine with an approved anti-cancer indication within 2 weeks prior to randomization. - Subject is undergone or planned to receive curative radiation therapy prior to randomization and during study. (The palliative radiation therapy such as for bony lesions is allowed, but irradiate on target lesion will not be allowed.) - Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to: - Uncontrolled nausea/vomiting/diarrhea; - Active uncontrolled infection; - Symptomatic congestive heart failure; - Unstable angina pectoris or cardiac arrhythmia; - Psychiatric illness/social situation that would limit compliance with study requirements; - History of gross hemoptysis; - Any medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities. - Subject is pregnant or lactating. - Subject participates in study using an investigational drug within 30 days prior to screening. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Shuang Ho Hospital | New Taipei City | |
Taiwan | Taipei Medical University Hospital | Taipei | |
Taiwan | Wan-Fang Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Hi-Q Marine Biotech International, Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life (QoL) | Comparison of the QoL score changes from Study Day -2 to End of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire | Day -2 to complete of Platinum-based Treatment Phase(week18) | |
Secondary | Quality of Life (QoL) | Comparison of the QoL score changes from Study Day -2 to C1D8, C3D1, and C5D1 of Platinum-based Treatment Phase between Oligo Fucoidan and placebo groups in intent to treat set (ITT) via the QoL questionnaire. | tinumDay -2 to C1D8(week1), Cycle 3(week9), and Cycle 5(week15) of Platinum-based Treatment Phase | |
Secondary | Progression-Free Survival (PFS) | Progression-Free Survival will be evaluated according to radiographic progression per RECIST version 1.1 and survival information (death) | Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required | |
Secondary | Objective Response Rate (ORR) | Objective Response Rate will be evaluated using measurements according to RECIST version 1.1 | Screening (baseline), Cycle 4(week12), complete of Platinum-based Treatment Phase(week18), EOT(week24), and 3 months post-treatment follow up if required | |
Secondary | Change of Cytokines | To evaluate the changes of cytokine | Screening (baseline), Cycle 3 (week 9), and complete of Platinum-based Treatment Phase(week18) |
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