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Carcinoma, Non-Small-Cell LungPhase 2AboundPS2NCT02289456

Phase II Safety and Tolerability Trial With Nab-Paclitaxel Plus Carboplatin Followed by Nab-Paclitaxel for First Line Treatment of NSCLC Subjects With ECOG PS 2

A Phase 2 study testing nab-Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Celgene at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
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
40 participants
Where
8 sitesUnited States
Study dates
28 Apr 2015to 22 Feb 2017
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General and Demographics
  • Age ≥ 18 years of age at the time of signing the Informed Consent Form.
  • Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
  • Able to adhere to the study visit schedule and other protocol requirements. Disease Specific
  • Histologically or cytologically confirmed Stage IIIB or IV Non-Small Cell Lung Cancer.
  • Radiographically documented measurable disease at study entry per response evaluation criteria in solid tumours ( RECIST) v1.1.
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  • No prior anti-cancer therapy for the treatment of metastatic disease at the time of signing the ICF. Adjuvant treatment is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
  • Platelets ≥ 100,000 cells/mm3.
  • Hemoglobin (Hgb) ≥ 9 g/dL.
  • Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT/serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × upper limit of normal range (ULN) or ≤ 5.0 × ULN if liver metastases.
  • Total bilirubin ≤ 1.5 × ULN except in cases of Gilbert's disease and liver metastases.
  • Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 40 mL/min (if renal impairment is suspected 24-hour urine collection for measurement is required).
  • Eastern Cooperative Oncology Group Performance Status 2.
  • Females of childbearing potential [defined as a sexually mature woman 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)] must:
  • Have a negative pregnancy test Beta Human Chorionic Gonaditrophin(ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy.
  • You must commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption; while receiving study medication or for a longer period if required by local regulations.
  • 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 at least 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for at least 21days prior to signing ICF). MRI of the brain (or CT scan w/contrast) is preferred for diagnosis.
  • History of leptomeningeal disease.
  • Only evidence of disease is non-measurable.
  • Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Criteria for Adverse Events (CTCAE) v4.0).
  • Subject has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product (IP), 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.
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  • Venous thromboembolism within 1 month prior to signing ICF.
  • Current congestive heart failure (New York Heart Association Class II-IV).
  • History of the following within 6 months prior to first administration of investigational product: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
  • Subject has a known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
  • Subject 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.
  • History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
  • Treatment with any investigational product within 28 days prior to signing the ICF.
  • History of or suspected allergy to nab-paclitaxel, carboplatin and human albumin or any other platinum-based therapy.
  • Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
  • 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.
  • Subject has any other malignancy within 5 years prior to signing the ICF. 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, node and metastasis (TNM) stage of T1a or T1b). All treatment should have been completed 6 months prior to signing ICF.
  • Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  • Any medical condition that confounds the ability to interpret data from the study. This includes subjects with known psychiatric disorders.
  • Pregnant or breast-feeding females.
  • Subjects with an ECOG PS other than 2

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University Cancer Institute

    Boynton Beach, Florida, 33426

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Ochsner Clinic Nephrology

    New Orleans, Louisiana, 70121

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • University of RochesterJames P. Wilmont Cancer Center

    Rochester, New York, 14642

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: A Phase II, Single Arm, Open-Label, Multicenter, Safety and Tolerability Trial With Nab-Paclitaxel (ABRAXANE®) Plus Carboplatin Followed by Nab-Paclitaxel Monotherapy as First-Line Treatment for Subjects With Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (NSCLC) and an Eastern Cooperative Oncology Group Performance Status of 2 (ABOUND.PS2)

4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles.

Keywords
Phase II, LOCALLY ADVANCED OR METASTATIC NON SMALL, CELL LUNG CANCER (NSCLC) AND AN, EASTERN COOPERATIVE ONCOLOGY GROUP, PERFORMANCE STATUS OF 2, (ABOUND.PS2), LOCALLY ADVANCED OR METASTATIC NON SMALL, CELL LUNG CANCER (NSCLC) SUBJECTS THAT AE NOT CANDIDATES FOR RADIATION OR CURATIVE SURGERY
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02289456
Study groupRoleWhat they receive
nab-PaclitaxelExperimentalnab-Paclitaxel 100 mg/m2 intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle • Carboplatin AUC = 5 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion.
Receives: Drug: nab-Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).

    Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, 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. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method.

    Measured: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months

Secondary outcomes (11)

  1. Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)

    Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period

    Measured: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months

  2. Dose Intensity of Nab-Paclitaxel During the Entire Study

    Dose intensity for nab-paclitaxel during the entire study period was (mg/m^2/week) = [cumulative dose for nab-paclitaxel in mg/m^2] / [nab-paclitaxel dosing period in weeks]

    Measured: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months

  3. Dose Intensity of Carboplatin During the Entire Study

    Dose intensity for carboplatin during the entire study period was (mg*min/mL/week) = [cumulative dose for carboplatin in mg*min/mL] / [carboplatin dosing period in weeks].

    Measured: From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months

  4. Percentage of Participants With Dose Reductions During the Entire Study

    A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.

    Measured: From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study

  5. 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 Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  6. Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)

    Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir

    Measured: Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  7. 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 Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  8. Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines

    Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment.

    Measured: Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  9. Time to Response

    Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline

    Measured: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  10. Kaplan Meier Estimate of Duration of Response

    Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method.

    Measured: From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months

  11. Number of Participants With TEAEs During the Induction and Monotherapy Periods

    Treatment-emergent adverse events were defined as any adverse event or serious adverse event 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. In addition, 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 were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.

    Measured: From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study start28 Apr 2015
  3. Primary completion22 Feb 2017
  4. Study completion22 Feb 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02289456
Sponsor's protocol ID
ABI-007-NSCL-004
Acronym
AboundPS2
Status last verified
Dec 2018
First submitted
10 Nov 2014
Last updated
7 Dec 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing nab-Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by Celgene at 8 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 19 inclusion and 21 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Apr 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 Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs). (time frame: From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02289456.

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 7 Dec 2018.

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