Recruiting
Phase 1
Phase 2

CASAD

Sponsor:

Salient Pharmaceuticals Incorporated

Code:

NCT01739634

Conditions

Diarrhea

Medullary Thyroid Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

CASAD

Study Details

Brief summary:

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.

Conditions

Diarrhea

Medullary Thyroid Cancer

Study ID

NCT01739634

Start date

Nov, 2012

Status verified date

Nov, 2012

Completion date

Dec, 2013

Anticipated

Primary completion date

Dec, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Drug

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.

Interventions

CASAD

CASAD is provided in 500mg capsules.

Primary outcome measure

  • Efficacy in treatment of diarrhea [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Maria E Cabanillas, MD

mcabani@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Maria E Cabanillas, MD

More Information

Sponsor

Salient Pharmaceuticals Incorporated

Last update posted

Dec 3, 2012

Last verified

Nov, 2012

Keywords

  • Diarrhea
  • Medullary thyroid cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Salient Pharmaceuticals Incorporated on 2012-12-03.