Tolvaptan in Hyponatremic Cancer Patients

NCT01199198 | Completed Phase 4 Results DMC

• 1 other identifier: 2009-0862
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancers

Keywords

Hyponatremia; Serum sodium; Tolvaptan; Placebo

Outcome Measures

Primary Outcomes (1)

• Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14

  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). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.

  14 days

Secondary Outcomes (1)

• Length of Stay in Hospital

  From administration of treatment to time of discharge

Study Arms (2)

Tolvaptan Group

EXPERIMENTAL

Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days.

Drug: Tolvaptan

Placebo Group

PLACEBO COMPARATOR

Placebo Group: Placebo by mouth once a day for 14 days.

Drug: Placebo

Interventions

Tolvaptan DRUG

Starting dose 15 mg by mouth once a day for 14 days.

Also known as: Samsca

Tolvaptan Group

Placebo DRUG

Placebo by mouth once a day for 14 days.

Also known as: Sugar Pill

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients must be greater than or equal to 18 years of age
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 at baseline.
• 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.
• Subjects must be able to comply with scheduled visits and follow-ups.
• Informed consent must be signed

You may not qualify if:

• History of hypersensitivity to tolvaptan
• Patients admitted to the critical care unit.
• Patients with renal failure(creatinine clearance less than 25 ml/min)
• Patients with a life expectancy less than 3 months
• Patients with volume depletion, BP \< 100/60 or urinary sodium \<20 meq/L.
• Patients who are not able to swallow or cannot take medication through feeding tubes
• Patients with diuretic-induced hyponatremia.
• Patients with spurious hyponatremia
• 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.
• The use of alcohol while participating in the study
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Hyponatremia

Interventions

Tolvaptan; Sugars

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Carmen Escalante,MD/Chair, General Internal Med
• Organization: University of Texas (UT) MD Anderson Cancer Center

cescalan@mdanderson.org

(713) 745-4516

Study Officials

• Abdulla K. Salahudeen, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 10, 2010
• Study Start: May 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 23, 2020
• Results First Posted: September 23, 2020

Record last verified: 2020-09

Locations

US (1)