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The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Besides the main objective, there are 4 other objectives as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oratecan and Capecitabine | Experimental | Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oratecan and Capecitabine | Drug | Oratecan in combination with Capecitabine
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination | If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0) | Cycle 1 (21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) | by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100. Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100. Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jina Jung, PhD | Hanmi Pharmaceuticals.Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Pharmaceuticals, Co., Ltd | Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| FG001 | Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| FG002 | Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| FG003 | Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| BG001 | Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination | If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0) | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 (21 days) |
|
From starting study medication to discontinuation of study medication
The patient took study medication until meet withdrawal criteria.
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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 | Capecitabine 800mg/㎡ + Oratecan 10mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of clinical research team | HanmiPharma | 8224109038 | jajung@hanmi.co.kr |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
|
| tumor response evaluation can continue to receive the study drug until PD confirmation |
| Treatment delay over 5 week |
|
One cycle was composed of 3 weeks. Oratecanâ„¢ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| BG002 | Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| BG003 | Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
One cycle was composed of 3 weeks. Oratecanâ„¢ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| OG002 | Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
| OG003 | Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. |
|
|
| Secondary | Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR) | by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100. Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100. Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100. | Posted | Number | 95% Confidence Interval | percentage of participants | tumor response evaluation can continue to receive the study drug until PD confirmation |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Capecitabine 800mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. | 1 | 8 | 8 | 8 |
| EG002 | Capecitabine 800mg/㎡ + Oratecan 20mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. | 1 | 4 | 4 | 4 |
| EG003 | Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡ | One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days. | 0 | 6 | 6 | 6 |
| Enteritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
The investigator will complete the report on this study through discussion with Hanmi Pharmaceutical Co., Ltd. after the study is completed. If the report is to be published, prior agreement in writing should be made between the two parties.
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| Response Rate |
|
| Disease Control Rate |
|