Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00802945 |
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Recruitment Status :
Completed
First Posted : December 5, 2008
Results First Posted : July 9, 2018
Last Update Posted : July 9, 2018
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Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Tumor Breast Cancer | Drug: NKTR-102 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Breast Cancer Whose Disease Has Failed Prior Taxane-Based Treatment |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | October 2011 |
| Actual Study Completion Date : | January 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: NKTR-102 q14d
NKTR-102
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Drug: NKTR-102
NKTR-102 given on a q14 day schedule |
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Experimental: NKTR-102 q21d
NKTR-102
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Drug: NKTR-102
NKTR-102 given on a q21 day schedule |
Primary Outcome Measures :
- Objective Response Rate (ORR) [ Time Frame: Up to 2 years. ]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.
Secondary Outcome Measures :
- Kaplan Meier Estimate of Progression-Free Survival (PFS) [ Time Frame: Up to 2 years. ]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.
- Kaplan Meier Estimate of Overall Survival (OS) [ Time Frame: Up to 2 years. ]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.
- Kaplan Meier Estimate of 6-month Survival [ Time Frame: From Cycle 1 Day 1 to the end of 6 months. ]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.
- Kaplan Meier Estimate of 1-year Survival [ Time Frame: From Cycle 1 Day 1 to the end of 12 months. ]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.
- Percent of Patients With Treatment-Emergent Adverse Events (TEAE): NCI-CTCAE Grade 3 or Higher With Incidence Rate ≥ 2% in Either Treatment Group [ Time Frame: Up to 2 years. ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Inoperable metastatic or locally advanced breast cancer
- No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
- Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802945
Locations
Show 19 study locations
Sponsors and Collaborators
Nektar Therapeutics
Investigators
| Study Director: | Alison Hannah, MD | Nektar Therapeutics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nektar Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00802945 |
| Other Study ID Numbers: |
08-PIR-05 |
| First Posted: | December 5, 2008 Key Record Dates |
| Results First Posted: | July 9, 2018 |
| Last Update Posted: | July 9, 2018 |
| Last Verified: | June 2018 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Etirinotecan pegol |
Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |