A Phase II Study of SPP-003 for Nephrotoxicity Induced by Cisplatin-based Chemotherapy
Chemotherapy Induced Nephrotoxicity Study
Aug. 31, 2020
Undecided
https://www.clinicaltrials.jp/file/XngdQrvad
version:
date:
SBI Pharmaceuticals Co., Ltd.
Izumi Garden Tower 20F, 1-6-1, Roppongi Minato-ku Tokyo
+81-3-6229-0095
info_ala@sbigroup.co.jp
SBI Pharmaceuticals Co., Ltd.
Izumi Garden Tower 20F, 1-6-1, Roppongi Minato-ku Tokyo
+81-3-6229-0095
info_ala@sbigroup.co.jp
completed
Nov. 13, 2018
100
Interventional
Multicenter, randomized, double-blind, placebo controlled, parallel group study.
treatment purpose
2
1. Japanese patients 20-79 years of age at the time of signing the consent form
2. Patients histologically or cytologically diagnosed with lung cancer (examples: patients newly diagnosed with stage IIIB/IV cancer, patients that have undergone systemic recurrence after receiving surgery for early-stage cancer, patients undergoing post-operative adjuvant chemotherapy)
3. Patients scheduled to receive chemotherapy including 60 mg/m2 or more of cisplatin (3-4 weeks per course) or 4 courses or more of post-operative adjuvant chemotherapy
4. Patients determined to have an ECOG Performance Status (ECOG PS) of 0-1 during screening
5. For female patients with child bearing potential, the patients who tested negative for a pregnancy during screening. Furthermore, patients who consent to contraceptive use such as a condom during the clinical trial period. Patients who are permanently infertile do not have to take a pregnancy test.
6. Patients whose laboratory test values at screening meet the following criteria:
Renal function
- Serum creatinine: Lower than ULN
- eGFR: 60 mL/min or above (based on the GFR prediction equation used by Japanese Society of Nephrology. Refer to Section 30.2 for details)
Liver function
- AST (GOT): 3 times or less of the ULN
- ALT (GPT): 3 times or less of the ULN
- Serum bilirubin: 1.5 times or less of the ULN (excluding the Gilbert's syndrome)
Blood
- Neutrophil count: 1,500/mm3 or above
- Platelet count: 100,000/mm3 or above
- Hemoglobin level: 9.0 g/dL or above
7. Patients predicted to reach 6 months or longer of survival
8. Patients who have provided written consent of their own free will upon understanding the content on the informed consent form
9. Patients capable of complying with the requirements of the protocol including visit days.
<Main Exclusion Criteria>
1. Patients with a past medical history of myocardial infarction or congestive heart failure within 3 months prior to obtaining consent.
2. Patients with serious complications (for example, interstitial pneumonia, pulmonary fibrosis, angina pectoris/arrhythmia requiring treatment, and inadequately controlled high blood pressure or diabetes mellitus)
3. Patients with severe infection (including active tuberculosis)
4. Patients with a treatment history of chemotherapy and radiation therapy including cisplatin treatment within 1 year prior to obtaining consent (however, with regards to patients that received radiation therapy for brain or CNS metastasis, patients that have recovered from the acute effects of radiation therapy, patients not requiring steroid treatment in increasing dosages, and patients that have completed treatment 1 week or longer, prior to beginning the administration of the study drug, are approved).
5. Patients that are scheduled to receive combination radiation therapy (however, palliative radiotherapy for bone metastasis is approved).
6. Patients with uncontrolled ascites and pleural effusion
7. Patients requiring regular treatment with nonsteroidal anti-inflammatory drug (NSAIDs) (excluding topical medications)
8. Patients requiring regular use of medications containing iron or porphyrin
9. Patients with abnormalities in iron metabolism function
10. Patients who are pregnant, lactating or scheduled to begin lactating during the clinical trial period
11. Patients who have tested positive for human immunodeficiency virus (HIV) or patients with acquired immunodeficiency syndrome (AIDS)
12. Patients who have tested positive for hepatitis B surface (HBs) antigens or hepatitis C virus (HCV) antibodies in screening test
13. Patients with acute or chronic porphyria or patients with a family history of porphyria
14. Patients suspected of serious hypersensitivity to the medications scheduled to be used in this clinical trial (5-ALA, SFC, cisplatin, etc.)
15. Patients who participated in another intervention study within 8 weeks prior to obtaining consent
16. Other patients that are deemed inapplicable by the principal investigator or the sub-investigator
20age old over
79age old under
Both
lung cancer
investigational material(s)
Generic name etc : SPP-003
INN of investigational material : 5-Aminolevulinic acid hydrochloride, Sodium Ferrous Citrate
Therapeutic category code : 419 Other agents activating cellular function
Dosage and Administration for Investigational material : oral, twice a day
control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : oral, twice a day
efficacy
Serum creatinine at 3 weeks after cisplatin administration in course 1
safety
efficacy
- Treatment completion rate
- Ratio of subjects who had serum creatinine increases of grade 1 and above
- eGFR, BUN, sCr, Hb volume and RBC count
- Adverse events
- laboratory test data
