Know Cancer

forgot password

NGR016: Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma (STS)

Phase 2
18 Years
Open (Enrolling)
Locally Advanced or Metastatic Soft Tissue Sarcoma

Thank you

Trial Information

NGR016: Randomized Phase II Study Evaluating Two Doses of NGR-hTNF Administered Either as Single Agent or in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma (STS)

Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate
constitutional symptoms when given either every three weeks or weekly both at low (0.8
µg/m^2) and high dose (45 µg/m^2); the reversibility of these adverse events generally
occurring only during the infusion time; the absence of overlapping toxicities with
chemotherapeutic agents; and the safety and preliminary antitumor activity observed in phase
Ib trial with doxorubicin, seems justified to evaluate in a randomized 4-arm phase II trial
the preliminary antitumor activity of two doses of NGR-hTNF (0.8 µg/m^2 and 45 µg/m^2)
administered weekly either alone or in combination with a standard dose of doxorubicin (60
mg/m^2 every three weeks).

Inclusion Criteria:

- Patients ≥ 18 years

- Histologically-proven, locally advanced, or metastatic STS (excluding extraosseus
Ewing sarcoma)

- Patients not amenable to surgery, radiotherapy, or combined-modality therapy with
curative intent

- Patients untreated or previously treated with one or more systemic regimen

- ECOG Performance status 0-2 (Appendix A)

- At least one untreated (not previously irradiated) target lesion that could be
measured in one dimension, according to RECIST criteria

- A life expectancy of 12 weeks or more

- Adequate baseline bone marrow, hepatic and renal function, defined as follows:

- Neutrophils > 1.5 x 109/L and platelets > 100 x 109/L

- Bilirubin < 1.5 x ULN

- AST and/or ALT < 2.5 x ULN in absence of liver metastasis or < 5 x ULN in
presence of liver metastasis

- Serum creatinine < 1.5 x ULN

- Creatinine clearance (estimated according to Cockcroft-Gault formula) ≥ 50

- Patients may have had prior treatment providing the following conditions are met
before treatment start:

- Surgery and radiation therapy: wash-out period of 14 days

- Systemic therapy: wash-out period of 21 days

- Patients must give written informed consent

Exclusion Criteria:

- Patients may not receive any other investigational agents while on study

- Patients with myocardial infarction within the last six (6) months, unstable angina,
New York Heart Association (NYHA) grade II or greater congestive heart failure, or
serious cardiac arrhythmia requiring medication

- LVEF < 55% (only for patients candidate for doxorubicin treatment)

- Uncontrolled hypertension

- Prolonged QTc interval (congenital or acquired) > 450 ms

- History or evidence upon physical examination of CNS disease unless adequately
treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with
standard medical therapy) or history of stroke

- Patients with active or uncontrolled systemic disease/infections or with serious
illness or medical conditions, which is incompatible with the protocol

- Known hypersensitivity/allergic reaction or contraindications to human albumin
preparations or to any of the excipients

- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol

- Pregnancy or lactation. Patients - both males and females - with reproductive
potential (i.e. menopausal for less than 1-year and not surgically sterilized) must
practice effective contraceptive measures throughout the study. Women of
child-bearing potential must provide a negative pregnancy test (serum or urine)
within 14 days prior to registration

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Defined as the time from the date of randomization until disease progression, or death

Outcome Time Frame:

every 6-12 weeks

Safety Issue:


Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.


Italy: Ethics Committee

Study ID:




Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Locally Advanced or Metastatic Soft Tissue Sarcoma
  • NGR-hTNF
  • Doxorubicin
  • Soft Tissue Sarcoma
  • Sarcoma