Clinical trial · Interventional
NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma
NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma. A Multicenter Open-label Single Arm Phase Ib/IIa Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As Last patient last visit (LPLV) took place on 15/02/2022, the trial was ended prematurely on this date in accordance with SAKK/CI.
Summary
Brief summary (as posted)
A clinical trial with biweekly regimen of gemcitabine and nab-paclitaxel for Soft tissue sarcomas (STSs). A Promising antitumor activity in patients with metastatic STS has been reported with gemcitabine alone or in combination with taxanes including docetaxel and paclitaxel in pre-treated patients. Nab-paclitaxel is a 130-nm albumin-bound formulation of paclitaxel particles (Celgene, Summit, NJ) which was designed to eliminate the toxicities associated with Cremophor®-EL. Nab-paclitaxel at equal dose of paclitaxel showed increased antitumor activity, enhanced endothelial cell transport and 33% higher intra-tumor paclitaxel concentration in preclinical models of solid tumor xenografts promising an advantageous pharmacokinetic profile In sarcoma, nab-paclitaxel demonstrated preclinical anti-tumor activity in rhabdomyosarcoma xenograft model. Local relapsed tumors following paclitaxel treatment proved to be paclitaxel-resistant but remained responsive to nab-paclitaxel. These findings provide the rationale for further evaluation of nab-paclitaxel in combination with gemcitabine for soft tissue sarcoma treatment.
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 |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-paclitaxel and gemcitabine
- description
- Treatment consists of the combination treatment of nab-paclitaxel and gemcitabine, which is given every 2 weeks during 28-day cycle intervals until disease progression.
- interventionNames
- Drug: Nab-Paclitaxel
- Drug: gemcitabine
Primary outcomes (2)
- measure
- Phase I: Dose-limiting toxicity (DLT)
- timeFrame
- during the first cycle of treatment (28 days)
- description
- DLT is defined as any of the following adverse events (AEs) occurring during the first cycle of treatment and regarded by the investigators and/or the Sponsor to be related to nab-paclitaxel and/or gemcitabine (AEs not related to the IMPs are not regarded as DLT)
- measure
- Phase II: Progression-free rate (PFR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed minimum grade 2, locally advanced or metastatic STS refractory to chemotherapy and not suitable for local treatment. * Minimum one line and maximum 2 lines of previous chemotherapy for advanced/metastatic STS * Measurable disease according to RECIST v1.1 * Age ≥ 18 years * WHO performance status 0-2 * Adequate hematological, hepatic and renal function * Negative pregnancy test * Effective method of birth control * Peripheral neuropathy at enrolment must be ≤ grade 1 Exclusion Criteria: * Uncontrolled CNS metastases * Previous or concomitant malignancy diagnosed within 3 years * More than 2 lines of previous systemic treatment for STS * Previous sarcoma treatment with gemcitabine and/or nab-paclitaxel or other taxanes * Radiotherapy within 4 weeks prior to registration * Concurrent or recent treatment with any other experimental drug * Concomitant use of other anti-cancer drugs * Severe or uncontrolled cardiovascular disease * History of cerebrovascular accident or intracranial hemorrhage within 2 months prior to registration * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease * Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or Hepatitis B Virus infection or any uncontrolled active systemic infection * Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information * Known hypersensitivity to the trial drug(s)
References
Publications (0)
Data not yet available