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Biotech / Medical : Ligand (LGND) Breakout!
LGND 205.55-1.3%Nov 12 3:59 PM EST
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To: medsunman who wrote (30123)1/11/2000 4:18:00 PM
From: Cheryl Galt  Read Replies (2) of 32384
 
The complete protocol - Ph II ABC trial (Bexarotene (LGD1069) Targretin) is in PDQ
at cancernet.nci.nih.gov

Excerpts of Trial Abstract:
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Phase II Randomized Study of Bexarotene (LGD1069) in Patients with Advanced Breast Cancer (Summary Last Modified 10/1999)


A total of 84-180 patients will be accrued for this study

OBJECTIVES:

I. Compare the efficacy of oral bexarotene (LGD1069) at two different dose levels
[200 and 500 mg/?] in patients with advanced breast cancer.

II. Assess the safety and tolerability of this treatment regimen in this patient population.

III. Evaluate the efficacy of oral bexarotene in terms of induction of differentiation and decreased aberrant cell proliferation in these patients.

Stratum 1 (hormonal):
Must be hormone receptor positive (ER or PR)
Prior hormonal therapy only allowed for metastatic disease
Must have progressed on last hormonal regimen

Stratum 2 (chemotherapy):
Hormone receptor positive or negative
Must have progressed on or after prior chemotherapy (1-2 regimens)
for metastatic disease (bone marrow transplant counts as 2 regimens)
Prior hormonal therapy allowed

Stratum 3 (tamoxifen):
Must be hormone receptor positive (ER or PR) and progressing on tamoxifen
No symptomatic visceral metastasis if on adjuvant tamoxifen at time of
systemic recurrence

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ENTRY CRITERIA include:
No bone metastases
No CNS metastases
No prior retinoid therapy for breast cancer
No history of or clinically significant risk factors for developing pancreatitis
Fasting triglycerides within normal range


[Note: These last two criteria will exclude people who would be at particular risk for Targretin's adverse effects.]


[Some of the other entry qualifications / disqualifications]

Biologic therapy:
Prior monoclonal antibody HER2 therapy for metastatic disease allowed
only if combined with chemotherapy or hormonal therapy and treatment failed
No concurrent immunotherapy

Chemotherapy:
No prior retinoid therapy for breast cancer
---------------------------------
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