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NCT01620190

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer

Completed Phase 2 Results posted Last updated 16 July 2021
What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Non-Small Cell Lung Carcinoma in 26 participants. Completed in 29 April 2019.

Timeline
2 December 2012
Primary endpoint
24 October 2017
29 April 2019

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment26
Start date2 December 2012
Primary completion24 October 2017
Estimated completion29 April 2019
Sites12 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, any sex, with Recurrent Non-Small Cell Lung Carcinoma or Stage IV Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria Primary · Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.

GroupValue95% CI
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)0
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)9
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)6
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)6
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy. Secondary · Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.

Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

GroupValue95% CI
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)4
Overall Survival Secondary · Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.

Will report as median values with their respective 95% confidence intervals will be reported. Time to event distribution will be estimated using Kaplan-Meier method.

GroupValue95% CI
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)3616.8 – 68
Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity. Secondary · Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.

Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

GroupValue95% CI
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)8
Time to Progression. Secondary · Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.

Reported as median values with their respective 95% confidence intervals for patients who were assessed. Time to event distribution will be estimated using the Kaplan-Meier method.

GroupValue95% CI
Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)10.23.4 – 60.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, assessed up to to 64 weeks. All-Cause Mortality was assessed up to 305 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Paclitaxel Albumin-stabilized Nanoparticle Formula)
Serious: 1/26 (4%)
Deaths: 6/26

Serious adverse events (1 terms)

ReactionSystemTreatment (Paclitaxel Albu…
HypotensionVascular disorders
Other adverse events (4 terms — click to expand)

ReactionSystemTreatment (Paclitaxel Albu…
Peripheral NeuropathyNervous system disorders
FatigueGeneral disorders
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations

Most-reported serious reactions: Hypotension.

Data from ClinicalTrials.gov NCT01620190 adverse events section.

Sponsor's own description

This research study examines the use of Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) in patients with lung cancer. Abraxane is a chemotherapy approved to treat patients with breast cancer. Doctors want to know if Abraxane is safe and effective in treating patients with lung cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) and epidermal growth factor receptor (EGFR) mutations.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Progressing nanotechnology to improve targeted cancer treatment: overcoming hurdles in its clinical implementation.
    Chehelgerdi M, Chehelgerdi M, Allela OQB, Pecho RDC, et al · · 2023 · cited 496× · PMID 37814270 · DOI 10.1186/s12943-023-01865-0
  2. Nano-Drug Delivery Systems Entrapping Natural Bioactive Compounds for Cancer: Recent Progress and Future Challenges.
    Chavda VP, Patel AB, Mistry KJ, Suthar SF, et al · · 2022 · cited 75× · PMID 35425710 · DOI 10.3389/fonc.2022.867655
  3. Nanoparticles advanced from preclinical studies to clinical trials for lung cancer therapy.
    Liu Y, Cheng W, Xin H, Liu R, et al · · 2023 · cited 42× · PMID 37009262 · DOI 10.1186/s12645-023-00174-x
  4. Exploring Protein-Based Carriers in Drug Delivery: A Review.
    Ferraro C, Dattilo M, Patitucci F, Prete S, et al · · 2024 · cited 19× · PMID 39339208 · DOI 10.3390/pharmaceutics16091172
  5. Functionalized Nanoparticles in Prevention and Targeted Therapy of Viral Diseases With Neurotropism Properties, Special Insight on COVID-19.
    Ren M, Wang Y, Luo Y, Yao X, et al · · 2021 · cited 11× · PMID 34867899 · DOI 10.3389/fmicb.2021.767104
  6. The Usefulness of Nanotechnology in Improving the Prognosis of Lung Cancer.
    Bordeianu G, Filip N, Cernomaz A, Veliceasa B, et al · · 2023 · cited 2× · PMID 36979684 · DOI 10.3390/biomedicines11030705
  7. [Application of Nano-drug Delivery Technology in Overcoming Drug Resistance 
in Lung Cancer].
    Lu Y, Wang C, Liu B. · · 2024 · cited 1× · PMID 39800482 · DOI 10.3779/j.issn.1009-3419.2024.101.30
  8. Advances in controlled release drug delivery systems based on nanomaterials in lung cancer therapy: A review.
    Fu J, Yu L, Wang Z, Chen H, et al · · 2025 · PMID 39928802 · DOI 10.1097/md.0000000000041415

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other recruiting trials for Recurrent Non-Small Cell Lung Carcinoma

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

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Data sources for this page

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