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A Phase I/II Study of Nelfinavir in Liposarcoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Adult Liposarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

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Trial Information

A Phase I/II Study of Nelfinavir in Liposarcoma


I. To assess the toxicity and tolerance of nelfinavir in patients with liposarcoma.

II. To define the maximum tolerated dose (MTD) of nelfinavir when given daily as a single
agent and to describe the toxicities at each does studied.

III. To evaluate the pharmacokinetics of nelfinavir. IV. To assess the response rate and
progression free survival in patients with liposarcoma treated with nelfinavir.

V. To evaluate the expression and activity of certain proteins in the tumors of patients
entered on this study, which may be important to the cytotoxicity of nelfinavir (SREBP-1,
p21, NFkappaB, caspase 3).

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive oral nelfinavir mesylate twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria


- Patients must have histologically confirmed liposarcoma, which is recurrent,
metastatic or unresectable

- There is no limit to prior chemotherapy regimens; in addition, patients may have
prior radiation

- All patients must have measurable disease, defined as lesions that can be accurately
measured in at least one dimension (>= 20 mm with conventional techniques or >= 10mm
with spiral CT scan); pleural effusions and ascites will not be considered
measurable, but may be present in addition to the measurable lesion(s)

- ECOG performance status of 0, 1, or 2; patients should have an expected survival of
at least 3 months

- Absolute neutrophil count >= 1,000/ul

- Platelets >= 75000/ul

- Total bilirubin =< 2.0 g/dl

- AST(SGOT)/ALT(SGPT) =< 2.0X institutional upper limit of normal

- Brain metastasis is not an exclusion; however, patients are only eligible if they
have had successful control of the brain tumor(s) by surgery or radiation therapy

- All prior therapy must have been completed at least 3 weeks prior to the patient's
entry on this trial

- No concurrent chemotherapy, radiotherapy, immunotherapy or other investigational

- Women of child-bearing potential and men must agree to use adequate contraception
(barrier method of birth control) prior to study entry and for the duration of study
participation; should a women become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately

- Ability to understand and willingness to sign a written informed consent document


- Patient has had prior treatment with or is currently taking a protease inhibitor

- Patients enrolled cannot be on the following medications: cisapride, triazolam,
midazolam, ergot derivatives, amiodarone, quinidine, dihydropyridine calcium
antagonists (amlodipine, felodipine, isradipine, nicardipine, nifedipine, nimodipine,
and nisoldipine), sildenafil, dilantin, rifampin or oral contraceptives

- Uncontrolled intercurrent illness

- Patients must have recovered from any expected toxicities of previous chemotherapy or
radiation therapy

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (Phase II)

Outcome Time Frame:

After 3 cycles of treatment

Safety Issue:


Principal Investigator

Warren Chow

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

Related Keywords:

  • Adult Liposarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Liposarcoma
  • Sarcoma



City of Hope Medical Center Duarte, California  91010
South Pasadena Cancer Center South Pasadena, California  91030