The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

Salient Pharmaceuticals

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diarrhea; Medullary Thyroid Cancer

Treatments: Drug: CASAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739634

SAL 2012-0584

Details and patient eligibility

About

Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with medullary thyroid cancer
• Men and women from all ethnic and racial groups
• Diarrhea ( >=3 loose bowel movements per day)
• Duration of diarrhea of at least 1 week

Exclusion criteria

• Patients with MEN 2b (since these patients may have megacolon)
• Patients taking any clay products
• History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
• Patients who cannot comply with medications
• Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
• Pregnancy or lactation
• Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Active Drug

Experimental group

Description:

After a 1 week run-in period CASAD will be administered TID for 1 week. Each dose will be 2 500mg CASAD capsules. Patients will be followed for two weeks post active drug administration.

Treatment:

Drug: CASAD