SAKK 57/16 NAPAGE Verabreichung von nab-Paclitaxel und Gemcitabin bei Patienten mit metastasierendem oder lokal fortgeschrittenem Weichteilsarkom. Offene, multizentrische, einarmige Phase Ib/IIa Studie.

Drug: Nab-Paclitaxel;Drug: gemcitabine

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)