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)