Non-Small Cell Lung CancerPhase 4ABOUND 70+NCT02151149
Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly
A Phase 4 study testing nab-paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer and Carcinoma, run by Celgene at 55 sites in United States.
Trial summary
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- nab-paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 55 sitesUnited States
- Study dates
- 9 Jun 2014to 14 Jul 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years at the time of signing the Informed Consent Form.
- Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
- Able to adhere to the study visit schedule and other protocol requirements.
- Histologically or cytologically confirmed locally advanced or metastatic non small cell lung cancer who are not candidates for curative surgery or radiation therapy.
- No other current active malignancy requiring anticancer therapy.
- Radiographically documented measurable disease per RECIST v 1.1
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- No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12 months prior to signing the informed consent form (ICF) and without disease recurrence. Participans with previously known epidermal growth factor receptor mutation or anaplastic lymphoma kinase gene translocation must have failed or had intolerance to one treatment with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.
- Absolute neutrophil count ≥ 1500 cells/cubic millimetre.
- Platelets ≥ 100,000 cells/cubic millimetre.
- Hemoglobin ≥ 9 grams/decilitre.
- Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
- Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of Gilberts Syndrome).
- Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault equation (if renal impairment is suspected 24 hour urine collection for measurement is required).
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Females who (1) have undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally postmenopausal for at least 24 consecutive months (ie, has not had menses at any time during the preceding 24 consecutive months).
- Male subjects must: Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.
Who cannot join
- 1. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.
- 2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
- 5. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- 6. Venous thromboembolism within 1 month prior to signing informed consent form.
- 7. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
- 9. Participant has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or participant is receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
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- 10. Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- 11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
- 12. Treatment with any investigational product within 28 days prior to signing the informed consent form.
- 13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices. 15. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
- 16. Participant has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer Tumor, Lymph Node, Metastatic (TNM stage of T1a or T1b). All treatment of which should have been completed 6 months prior to signing Informed consent form.
- 17. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- 18. Any medical condition that confounds the ability to interpret data from the study.
- 19. Females who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
United States55 sites
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, 79106
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Medstar Health Research Institute
Baltimore, Maryland, 21237
Lynn Cancer Institute
Boca Raton, Florida, 33486
Brookdale University Hospital and Medical Center
Brooklyn, New York, 11212
Lineberger Cancer Center
Chapel Hill, North Carolina, 27599
Levine Cancer Institute
Charlotte, North Carolina, 28204
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003
Good Samaritan Hospital Corvalis
Corvallis, Oregon, 97330
Baylor University Medical Center at Dallas
Dallas, Texas, 75246
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
Henry Ford Health System
Detroit, Michigan, 48202-268
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816
Northshore University Healthsystem Research Institute
Evanston, Illinois, 60201
Saint Jude Heritage Medical Center
Fullerton, California, 92835
UTMB Galveston
Galveston, Texas, 77555-0565
Global Cancer Research Institute (GCRI), Inc.
Gilroy, California, 95020
St Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Genesis Cancer Center
Hot Springs, Arkansas, 71913
Franciscan St. Francis Health
Indianapolis, Indiana, 46237
Baptist Cancer Inst
Jacksonville, Florida, 32207
Broome Oncology, LLC
Johnson City, New York, 13790
Clinical Research Alliance
Lake Success, New York, 11042
Cancer Centres of Southwest Okahoma Research
Lawton, Oklahoma, 73505
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Texas Oncology, PA - Longview
Longview, Texas, 75601
West Jeffersion Medical Center
Marrero, Louisiana, 70072
Carol G Simon Cancer Center
Morristown, New Jersey, 07962
Ochsner Medical Institutions
New Orleans, Louisiana, 70123
Oncology Specialists, S.C.
Niles, Illinois, 60714
Ocala Oncology Center
Ocala, Florida, 34471
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030
Western Kentucky Hematology and Oncology Group
Paducah, Kentucky, 42003
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Medical College
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health and Science University
Portland, Oregon, 97210
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
University of California Los Angeles
Santa Monica, California, 90404
Virginia Mason Cancer Center
Seattle, Washington, 98101
Somerset Hematology-Oncology Associates
Somerville, New Jersey, 08876
Regional Cancer Care Associates LLC- Sparta division
Sparta, New Jersey, 07871
SUNY Upstate Medical University Medicine Oncology
Syracuse, New York, 13215
Montefiore Medical Center
The Bronx, New York, 10461
Arizona Clinical Research Center
Tucson, Arizona, 85715
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Cancer Center of Kansas
Wichita, Kansas, 67214
Forsyth Memorial Hospital, Inc.
Winston-Salem, North Carolina, 27103
Reliant Medical Group
Worcester, Massachusetts, 01608
St Elizabeth Hospital
Youngstown, Ohio, 44501
About this study
Official title: Safety and Efficacy of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Open-Label, Multicenter Study (Abound.70+)
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC
Read the detailed description
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell Carcinoma, Adenocarcinoma, Carcinoma, Large Cell, Lung Neoplasm
- Being tested
- nab-paclitaxel, Carboplatin
- Keywords
- NSCLC advanced non-small cell lung cancer squamous adenocarcinoma large cell carcinoma lung cancer elderly first line treatment abraxane carbo nab-paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Carcinoma, Squamous Cell, Adenocarcinoma, Carcinoma, Large Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-paclitaxelDrug
Also called Abraxane
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A: nab-Paclitaxel and Carboplatin (Every 21 days) | Other | nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle Receives: Drug: nab-paclitaxel; Drug: Carboplatin |
| Arm B: nab-Paclitaxel and Carboplatin (Every 28 days) | Other | nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break Receives: Drug: nab-paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values
Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3.
Measured: From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.
Secondary outcomes (9)
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period
Treatment-emergent adverse events (TEAEs) were defined as any AE or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. Any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the scale:
Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death.
Measured: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn
The percentage of participants with at least 1 TEAE with action taken as studydrug withdrawn during the treatment period of the trial was assessed throughout the conduct of the study. Study drug withdrawn (treatment permanently discontinued) was attributed to the part in which the onset of the adverse event took place.
Measured: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study
Dose intensity was the cumulative dose divided by the dosing period in weeks.
Measured: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Dose Intensity Per Week of Carboplatin During the Entire Study
Dose intensity for carboplatin was the cumulative dose divided by the dosing period in weeks."
Measured: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Percentage of Participants With Dose Reductions During the Entire Study
A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.
Measured: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Percentage of Participants With a Dose Delay During the Entire Study
A dose delay occurred when the dose assigned at a visit was held compared to the previous visit. Dose delays were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.
Measured: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Kaplan Meier Estimate of Progression-Free Survival (PFS)
Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir
Measured: From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively
Kaplan Meier Estimate of Overall Survival (OS)
Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Measured: From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria
Overall response rate (ORR) was defined as the percentage of participants who had radiologic CR or PR compared to baseline (radiographic evaluation on the day of or within 28 days prior to randomization) according to RECIST Version 1.1 criteria as determined by the investigator, which was confirmed by repeated radiologic assessment performed no less than 28 days after the criteria for response were first met and occurred between Day 1 of treatment and the start of subsequent anticancer therapy, death or study discontinuation. A complete response and partial response per RECIST V 1.0 criteria was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of diameters of target lesions from baseline.
Measured: From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study start9 Jun 2014
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teng Jin Ong, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151149
- Sponsor's protocol ID
- ABI-007-NSCL-005
- Acronym
- ABOUND 70+
- Status last verified
- Aug 2018
- First submitted
- 28 May 2014
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Open-Label, Multicenter Study (Abound.70+)
- ClinicalTrials.gov ID
- NCT02151149
- Acronym / sponsor ID
- ABOUND 70+ / ABI-007-NSCL-005
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell Carcinoma, Adenocarcinoma, Carcinoma, Large Cell, Lung Neoplasm
- Keywords
- NSCLC advanced non-small cell lung cancer squamous adenocarcinoma large cell carcinoma lung cancer elderly first line treatment abraxane carbo nab-paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2014 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 24 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC
Detailed description
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: nab-Paclitaxel and Carboplatin (Every 21 days) | Other | Drug: nab-paclitaxel, Drug: Carboplatinnab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle |
| Arm B: nab-Paclitaxel and Carboplatin (Every 28 days) | Other | Drug: nab-paclitaxel, Drug: Carboplatinnab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
Key exclusion criteria (14 listed)
- 1. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.
- 2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
- 5. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- 6. Venous thromboembolism within 1 month prior to signing informed consent form.
- 7. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-paclitaxelAlso: Abraxane | Drug | Arm A: nab-Paclitaxel and Carboplatin (Every 21 days), Arm B: nab-Paclitaxel and Carboplatin (Every 28 days) |
| Carboplatin | Drug | Arm A: nab-Paclitaxel and Carboplatin (Every 21 days), Arm B: nab-Paclitaxel and Carboplatin (Every 28 days) |
Primary outcome
Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values
Time frame: From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.
Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3.
9 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events During the Treatment Period
Time frame: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn
Time frame: From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study
Time frame: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Dose Intensity Per Week of Carboplatin During the Entire Study
Time frame: From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Percentage of Participants With Dose Reductions During the Entire Study
Time frame: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Percentage of Participants With a Dose Delay During the Entire Study
Time frame: From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively
Kaplan Meier Estimate of Progression-Free Survival (PFS)
Time frame: From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively
Kaplan Meier Estimate of Overall Survival (OS)
Time frame: From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively
Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria
Time frame: From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teng Jin Ong study director
Celgene
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nab-paclitaxel and Carboplatin in people with Non-Small Cell Lung Cancer and Carcinoma, run by Celgene at 55 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values (time frame: From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.