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This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.
Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR-102 q14d | Experimental | NKTR-102 |
|
| NKTR-102 q21d | Experimental | NKTR-102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-102 | Drug | NKTR-102 given on a q14 day schedule |
| |
| NKTR-102 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan Meier Estimate of Progression-Free Survival (PFS) | Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. | Up to 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Hannah, MD | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90089-9177 | United States | ||
| Desert Hematology Oncology Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24095299 | Derived | Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, Mehdi A, O'Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young DE, Zhao C, Chia YL, Hoch U, Hannah AL, Perez EA; NKTR-102 Study Group. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013 Nov;14(12):1216-25. doi: 10.1016/S1470-2045(13)70429-7. Epub 2013 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NKTR-102 14 Day | NKTR-102: NKTR-102 given on a q14 day schedule |
| FG001 | NKTR-102 21 Days | NKTR-102: NKTR-102 given on a q21 day schedule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
NKTR-102 given on a q21 day schedule |
|
| Kaplan Meier Estimate of Overall Survival (OS) | OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population. | Up to 2 years. |
| Kaplan Meier Estimate of 6-month Survival | Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population. | From Cycle 1 Day 1 to the end of 6 months. |
| Kaplan Meier Estimate of 1-year Survival | One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population. | From Cycle 1 Day 1 to the end of 12 months. |
| Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death. | Up to 2 years. |
| Rancho Mirage |
| California |
| 92270 |
| United States |
| Stockton Hematology/Oncology | Stockton | California | 95204 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Louisville Oncology Clinical Research Program | Louisville | Kentucky | 40207 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Pharma Resource | East Providence | Rhode Island | 02915 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Institut Jules Bordet | Brussels | 2-2-541-72-26 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| De Pintelaan 1885 | Ghent | 9000 | Belgium |
| CHU de Liege | Liège | 4000 | Belgium |
| GasthuisZusters Antwerpen | Wilrijk | 2610 | Belgium |
| Clatterbridge Centre for Oncology | Bebington | CH63 3J7 | United Kingdom |
| Velindre Hospital | Cardiff | CH14 2TL | United Kingdom |
| Beatson Oncology Center | Glasgow | G12 ONY | United Kingdom |
| St James University Hospital | Leed | LS97TF | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NKTR-102 14 Day | NKTR-102 NKTR-102: NKTR-102 given on a q14 day schedule |
| BG001 | NKTR-102 21 Days | NKTR-102 NKTR-102: NKTR-102 given on a q21 day schedule |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Objective Response Rate (ORR) | Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | 95% Confidence Interval | percentage of subjects | Up to 2 years. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate of Progression-Free Survival (PFS) | Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate of Overall Survival (OS) | OS was calculated as the time from the date of first study drug administration until death from any cause. Subjects alive at the time of analysis were censored at the time they were last known alive. OS was analyzed for the ITT population. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate of 6-month Survival | Six-month survival (i.e., overall survival proportion at 6 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population. | Posted | Number | 95% Confidence Interval | percentage of subjects | From Cycle 1 Day 1 to the end of 6 months. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate of 1-year Survival | One year survival (i.e., overall survival proportion at 12 months) was estimated using Kaplan Meier method. The analyses were performed in the ITT population. | Posted | Number | 95% Confidence Interval | percentage of subjects | From Cycle 1 Day 1 to the end of 12 months. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. TEAE was any event not present before exposure to the study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug. All AEs were assessed for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. If a particular AE was not listed in the NCI CTCAE Version 3.0, the following criteria were used: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life threatening or disabling; Grade 5 = Death. | Posted | Number | percentage of subjects | Up to 2 years. |
|
From the time of informed consent to the last study visit (30 days after the last infusion of study drug), up to 2 years.
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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 | NKTR-102 14 Day | NKTR-102: NKTR-102 given on a q14 day schedule | 27 | 35 | 18 | 35 | 35 | 35 |
| EG001 | NKTR-102 21 Days | NKTR-102: NKTR-102 given on a q21 day schedule | 23 | 35 | 15 | 35 | 35 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphoedema | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| ECG Signs Of Myocardial Ischaemia | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lung Consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Monoplegia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Neutropenic Sepsis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.
There are restrictions to the PI's rights to discuss or publish trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Hannah, MD | Nektar | AHannah@nektar.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C581703 | etirinotecan pegol |
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| >=65 years |
|
| Male |
|
| United States |
|
| United Kingdom |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|