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This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-02L (darinaparsin for injection) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-02L (darinaparsin for injection) | Drug | Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response (Central Assessment) | Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response. | Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response (Local Assessment) | Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response. |
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Inclusion Criteria:
Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region
Patients aged ≥20 years on the date of informed consent
Patients with histologically confirmed diagnosis of one of the following:
Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease
Have at least 1 measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with a life expectancy of at least 3 months as determined by the investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong | Hong Kong | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36661315 | Derived | Kim WS, Fukuhara N, Yoon DH, Yamamoto K, Uchida T, Negoro E, Izutsu K, Terui Y, Nakajima H, Ando K, Suehiro Y, Kang HJ, Ko PS, Nagahama F, Sonehara Y, Nagai H, Tien HF, Kwong YL, Tobinai K. Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study. Blood Adv. 2023 Sep 12;7(17):4903-4912. doi: 10.1182/bloodadvances.2022008615. |
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67 patients were enrolled and 65 were treated.
Patients were recruited in Japan, Korea, Taiwan and Hong Kong during the period from March 25, 2016 to September 17, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | SP-02L (Darinaparsin for Injection) | SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2020 | Jun 30, 2022 |
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| Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months. |
| Progression-Free Survival | Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months. |
| Overall Survival | Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause. | Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months. |
| Number of Participants With Adverse Events (AEs) | AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months. |
| Nagoya |
| Aichi-ken |
| Japan |
| Yoshida-gun | Fukui | Japan |
| Isehara | Kanagawa | Japan |
| Yokohama | Kanagawa | Japan |
| Sendai | Miyagi | Japan |
| Suita | Osaka | Japan |
| Chuo-ku | Tokyo | Japan |
| Koto-ku | Tokyo | Japan |
| Minato-ku | Tokyo | Japan |
| Fukuoka | Japan |
| Gifu | Japan |
| Okayama | Japan |
| Goyang-si | Gyeonggi-do | South Korea |
| Hwasun-gun | Jeollanam-do | South Korea |
| Gangnam-gu | Seoul | South Korea |
| Nowon-gu | Seoul | South Korea |
| Seodaemun-gu | Seoul | South Korea |
| Songpa-gu | Seoul | South Korea |
| Beitou | Taipei | Taiwan |
| Zhongzheng | Taipei | Taiwan |
| Taichung | Taiwan |
| Tainan | Taiwan |
| Taoyuan | Taiwan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all patients who received at least one dose of SP-02L (darinaparsin for injection).
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| ID | Title | Description |
|---|---|---|
| BG000 | SP-02L (Darinaparsin for Injection) | SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Histopathological Diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response (Central Assessment) | Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | Posted | Number | 90% Confidence Interval | percentage of participants | Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months. |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Tumor Response (Local Assessment) | Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | Posted | Number | 90% Confidence Interval | percentage of participants | Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | Posted | Median | 90% Confidence Interval | months | Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause. | Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection). | Posted | Median | 90% Confidence Interval | months | Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months. |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE). | Posted | Count of Participants | Participants | From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months. |
|
|
From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SP-02L (Darinaparsin for Injection) | SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days | 6 | 65 | 30 | 65 | 64 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Biliary fistula | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Epiglottitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Department | Solasia Pharma K.K. | +81358438045 | clinicaldev@solasia.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 19, 2021 | Jul 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C515055 | darinaparsin |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Taiwan |
|
| Hong Kong |
|
| Anaplastic large cell lymphoma, ALK-negative |
|
| Anaplastic large cell lymphoma, ALK-positive |
|
| Other |
|
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|
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