Tolvaptan in Hyponatremic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199198
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : January 9, 2015
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if tolvaptan can help raise salt (sodium) levels in the cancer patients' blood by removing extra body water as urine.

Condition or disease Intervention/treatment Phase
Advanced Cancers Drug: Tolvaptan Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer
Study Start Date : May 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: Tolvaptan Group
Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days.
Drug: Tolvaptan
Starting dose 15 mg by mouth once a day for 14 days.
Other Name: Samsca

Placebo Comparator: Placebo Group
Placebo Group: Placebo by mouth once a day for 14 days.
Drug: Placebo
Placebo by mouth once a day for 14 days.
Other Name: Sugar Pill

Primary Outcome Measures :
  1. Proportion of Patients whose Serum Sodium Concentration Corrected to at least 135 mEq/L on Day 14 [ Time Frame: 14 days ]
    Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care).

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Euvolemic or hypervolemic (patients with heart or liver failure) with cancer admitted to MD Anderson Cancer Center for any reasons with serum sodium between 125 and 130 mEq/L (both inclusive)
  2. Patients must be greater than or equal to 18 years of age
  3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 at baseline.
  4. Women of childbearing potential must use a medically accepted method of contraception and to continue use of this method for the duration of the study and for 30 days after study participation. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method. Men must practice abstinence or use a barrier method of birth control, and must agree to continue use for the duration of the study and for 30 days after study participation.
  5. Subjects must be able to comply with scheduled visits and follow-ups.
  6. Informed consent must be signed

Exclusion Criteria:

  1. History of hypersensitivity to tolvaptan
  2. Patients admitted to the critical care unit.
  3. Patients with renal failure(creatinine clearance less than 25 ml/min)
  4. Patients with a life expectancy less than 3 months
  5. Patients with volume depletion, BP < 100/60 or urinary sodium <20 meq/L.
  6. Patients who are not able to swallow or cannot take medication through feeding tubes
  7. Patients with diuretic-induced hyponatremia.
  8. Patients with spurious hyponatremia
  9. Patients with hyponatremia related to psychogenic polydypsia, head trauma, post operative conditions, uncontrolled hypothyroidism or cortisol insufficiency or any hyponatremia associated with the use of medication that can be safely withdrawn.
  10. The use of alcohol while participating in the study
  11. Currently taking demeclocycline, lithium, benzazepine derivatives, ketoconazole, grapefruit, grapefruit juice and receiving strong CYP3A inhibitors such as clarithromycin, fluconazole, voriconazole, posaconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01199198

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
Principal Investigator: Abdulla K. Salahudeen, MD UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01199198     History of Changes
Other Study ID Numbers: 2009-0862
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: September 2013

Keywords provided by M.D. Anderson Cancer Center:
Serum sodium

Additional relevant MeSH terms:
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs