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A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chondrosarcoma

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Trial Information

A Phase 2 Study of GDC-0449 in Patients With Advanced Chondrosarcomas


PRIMARY OBJECTIVES:

I. Evaluate the antitumor activity of GDC-0449 (vismodegib) in terms of 6-month clinical
benefit rate (complete response, partial response, and stable disease, as per the revised
RECIST criteria 2009).

SECONDARY OBJECTIVES:

I. Determine the best overall response (as per the revised RECIST criteria 2009).

II. Determine the 1- and 2-year progression-free survival. III. Determine the 1- and 2-year
overall survival. IV. Assess GDC-0449 safety. V. Conduct a pharmacogenomic analysis of
predictive markers of treatment outcome.

OUTLINE: This is a multicenter study.

Patients receive vismodegib orally (PO) on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicities.

Tumor samples are analyzed for correlative, including biomarker, studies.

After completion of study therapy, patients are followed up every 3 months.


Inclusion Criteria:



- Patients must have histologically confirmed diagnosis of chondrosarcoma
(conventional, mesenchymal, dedifferentiated or clear cell subtypes)

- Metastatic or unresectable locally advanced disease

- Documented disease progression (as per RECIST) before study entry

- Patients must have measurable disease (outside any previously irradiated field)
defined as at least one lesion that can be accurately measured in at least one
dimension (longest diameter to be recorded) as >= 10 mm with spiral CT scan

- No more than three prior lines of chemotherapy for advanced disease (including no
more than 450 mg/m² doxorubicin)

- Tumor tissue sample available for pathological review and/or correlative studies

- No known brain metastases

- ECOG performance status < 2 (Karnofsky > 60%)

- Life expectancy of greater than 3 months

- Leukocytes > 3,000/mcL

- Absolute neutrophil count > 1,500/mcL

- Platelets > 100,000/mcL

- Total bilirubin within normal institutional limits

- AST/ALT < 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min

- Not pregnant or nursing

- Negative serum pregnancy test

- Women of child-bearing potential and men must use two forms of contraception (i.e.,
barrier contraception and one other method of contraception) at least 4 weeks prior
to study entry, for the duration of study participation, and for at least 12 months
post-treatment

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to GDC-0449 or other agents used in the study

- No malabsorption syndrome or other condition that would interfere with intestinal
absorption

- Able to swallow capsules

- Patients with clinically important history of liver disease, including viral or other
hepatitis, or cirrhosis are ineligible

- Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia
defined as less than the lower limit of normal for the institution, despite adequate
electrolyte supplementation, are excluded from this study

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

- HIV-positive patients on combination antiretroviral therapy are ineligible

- No other investigational or commercial agents or therapies may be administered with
the intent to treat the patient's malignancy

- At least three weeks since last chemotherapy (six weeks in case of nitrosoureas and
mitomycin C), immunotherapy, radiotherapy, and/or any other pharmacological treatment
and recovered

- Patients may not be receiving any other investigational agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical benefit (CR + PR + SD) rate

Outcome Description:

At six months, patients will be classified as success (alive at 6 months AND CR/PR/ SD) or failure (dead OR alive with progression).

Outcome Time Frame:

At 6 months

Safety Issue:

No

Principal Investigator

Antoine Italiano

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Bergonie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02564

NCT ID:

NCT01267955

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Chondrosarcoma
  • Chondrosarcoma

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