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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2022
• Main ID: NCT03524898
• Date of registration: 24/04/2018
• Prospective Registration: Yes
• Primary sponsor: Swiss Group for Clinical Cancer Research
• Public title: NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma
• Scientific title: NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma. A Multicenter Open-label Single Arm Phase Ib/IIa Trial
• Date of first enrolment: October 2, 2018
• Target sample size: 39
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03524898
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Antonia Digklia, MD
• Affiliation: Département d'Oncologie CHUV , Lausanne

• Name: Christian Rothermundt, MD
• Affiliation: Cantonal Hospital of St. Gallen

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Soft Tissue Sarcoma

Intervention(s)

Drug: Nab-Paclitaxel

Drug: gemcitabine

Primary Outcome(s)

Phase I: Dose-limiting toxicity (DLT) [Time Frame: during the first cycle of treatment (28 days)]

Phase II: Progression-free rate (PFR) [Time Frame: at 12 weeks after registration]

Secondary Outcome(s)

Phase II: AEs, assessed according to NCI CTCAE v4.03 [Time Frame: from registration until 28 days after administration of the last dose of trial treatment]

Phase II: Overall Survival (OS) [Time Frame: assessed for up to 5 years after patient registration]

Phase II: Progression-free survival (PFS) [Time Frame: assessed for up to 5 years after patient registration]

Phase I: PFR 12 weeks [Time Frame: at 12 weeks after registration]

Phase II: Best response assessed according to RECIST v1.1 [Time Frame: assessed for up to 5 years after patient registration]

Phase I: Adverse events (AEs), assessed according to NCI CTCAE v4.03 [Time Frame: assessed for up to 5 years after patient registration]

Phase II: Nab-paclitaxel related sensory neuropathy assessed by questionnaires [Time Frame: assessed for up to 5 years after patient registration]

Phase I: Best response assessed according to RECIST v1.1 [Time Frame: assessed for up to 5 years after patient registration]

Phase II: Symptom-related quality of life assessed by questionnaires [Time Frame: assessed for up to 5 years after patient registration]

Secondary ID(s)

SAKK 57/16 - NAPAGE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors