Overview

NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma

Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Swiss Group for Clinical Cancer Research
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Criteria
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)