Clinical trial · Interventional
ABI-007 in Treating Patients With Chemotherapy-Naïve Stage IV Non-Small Cell Lung Cancer
An Open-Label, Phase I/II Trial Of ABI-007 (A CREMOPHOR® El-Free, Protein Stabilized, Nanoparticle Paclitaxel) Administered Weekly In Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I/II trial is studying the side effects and best dose of ABI-007 and to see how well it works in treating patients with stage IV non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| paclitaxel albumin-stabilized nanoparticle formulation | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ABI-007
- measure
- Objective target lesion response (complete or partial) as measured by RECIST criteria
Secondary outcomes (10)
- measure
- Incidence of treatment-emergent adverse events and serious adverse events
- measure
- Nadir of myelosuppression
- measure
- Changes in hematologic and clinical chemistry values
- measure
- Changes in physical examination
- measure
- Incidence of dose modifications, dose interruptions, and/or premature discontinuation of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed stage IV non-small cell lung cancer
* Evidence of inoperable local recurrence or metastasis
* Bone metastases or other nonmeasurable disease may not be only evidence of metastasis
* Measurable disease documented radiographically
* No evidence of active brain metastases or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1 OR
* Karnofsky 80-100%
Life expectancy
* More than 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin normal
* Alkaline phosphatase ≤ 2.5 times ULN (unless due to bone metastases and there is no radiologic evidence of hepatic metastases)
Renal
* Creatinine ≤ 1.5 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception for 1 month before and during study participation
* No prior allergy or hypersensitivity to study drug
* No other concurrent active malignancy
* No pre-existing peripheral neuropathy grade 1 or greater
* No other concurrent clinically significant illness
* No concurrent serious medical risk factor involving any of the major organ systems that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for metastatic disease
* More than 4 weeks since prior cytotoxic chemotherapy
* No concurrent doxorubicin
* No other concurrent taxanes
* No concurrent anthracyclines
Endocrine therapy
* Not specified
Radiotherapy
* At least 3 weeks since prior radiotherapy to a major bone marrow-containing area
* More than 4 weeks since prior radiotherapy except to a non-target lesion
* Prior radiotherapy to a target lesion allowed provided there has been clear progression of the lesion since completion of radiotherapy
Surgery
* Not specified
Other
* Prior epidermal growth factor-targeted therapy allowed
* More than 4 weeks since prior investigational drugs
* No concurrent enrollment in another clinical trial in which investigational drugs are administered or investigational procedures are performed
* No concurrent treatment with any of the following:
* Ritonavir
* Saquinavir
* Indinavir
* Nelfinavir
* No concurrent anticonvulsants
* No other concurrent anticancer drugs
* No other concurrent investigational drugsReferences
Publications (2)
- RESULTPaik PK, James LP, Riely GJ, Azzoli CG, Miller VA, Ng KK, Sima CS, Heelan RT, Kris MG, Moore E, Rizvi NA. A phase 2 study of weekly albumin-bound paclitaxel (Abraxane(R)) given as a two-hour infusion. Cancer Chemother Pharmacol. 2011 Nov;68(5):1331-7. doi: 10.1007/s00280-011-1621-0. Epub 2011 Apr 3. PMID 21461889
- RESULTRizvi NA, Riely GJ, Azzoli CG, Miller VA, Ng KK, Fiore J, Chia G, Brower M, Heelan R, Hawkins MJ, Kris MG. Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2008 Feb 1;26(4):639-43. doi: 10.1200/JCO.2007.10.8605. PMID 18235124