Advanced CancersPhase 4NCT01199198
Tolvaptan in Hyponatremic Cancer Patients
A Phase 4 study testing Tolvaptan in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Tolvaptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer
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.
Read the detailed description
The Study Drug:
Tolvaptan is designed to help raise salt levels in your blood by removing extra body water as urine.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will take tolvaptan and receive standard of care
- If you are in Group 2, you will take a placebo and receive the standard of care for patients with hyponatremia. A placebo is a tablet that looks like the study drug but has no active ingredients.
You will not know which group you are assigned. However, if needed for your safety, you will be able to find out what you are receiving at any time.
Study Drug Administration:
You will take tolvaptan or the placebo 1 time every day by mouth for 14 days.
If you are receiving the placebo, you will also receive the standard of care for hyponatremia. Examples of the standard of care include limiting your water and fluid intake, or giving you salt tablets and other drugs such as diuretics. Your doctor will describe these in more detail.
You will be given a drug diary to record when you take the study drug/placebo. You will return any unused drug/placebo at the end of 14 days.
You should avoid grapefruit and grapefruit juice while you are taking tolvaptan.
Study Visits:
At every visit, you will be asked if you have had any side effects.
On Days 1, 2, and 3:
- Blood (about 1 teaspoon) will be drawn for routine tests. On Day 1, this sample will be drawn 2 times.
- Your weight and vital signs will be measured.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- You will be asked about any drugs that you may be taking.
- If the doctor thinks it is needed, you will have a physical exam.
On Day 7:
- Your medical history will be reviewed and updated.
- You will be asked about any drugs that you may be taking.
- Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
- Your weight and vital signs will be measured.
On Day 14:
- Your medical history will be reviewed and updated.
- Your weight and vital signs will be measured.
- Blood (about 1 teaspoon) and urine will be collected for routine tests and tests to measure how concentrated your blood and urine are.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- You will be asked about any drugs that you may be taking.
- You will complete the MMSE.
If the doctor thinks it is needed, you will have a physical exam.
Length of Study:
You will take the study drug/placebo for 14 days. You will be taken off study if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study- Day 30 Follow-up Visit:
At 30 days after the last dose of study drug (or placebo), you will have an end-of-study visit in clinic or by telephone. At this visit, the following tests and procedures will be performed.
- Your medical history will be reviewed and updated.
- Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
- You will be asked about any side effects that you may be having and any drugs that you may be taking.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- If the doctor thinks it is needed, you will have a physical exam.
This is an investigational study. Tolvaptan is FDA approved and commercially available to treat hyponatremia (low levels of salt [sodium] in the blood due to too much body water). Its use in patients with cancer who have hyponatremia is investigational.
Up to 170 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Tolvaptan, Placebo
- Keywords
- Hyponatremia, Serum sodium, Tolvaptan, Placebo
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolvaptanDrug
Also called Samsca
Starting dose 15 mg by mouth once a day for 14 days.
PlaceboDrug
Also called Sugar Pill
Placebo by mouth once a day for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tolvaptan Group | Experimental | Tolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days. Receives: Drug: Tolvaptan |
| Placebo Group | Placebo comparator | Placebo Group: Placebo by mouth once a day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (1)
Length of Stay in Hospital
Measured: From administration of treatment to time of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startMay 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdulla K. Salahudeen, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199198
- Sponsor's protocol ID
- 2009-0862
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2010
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of Tolvaptan in Hyponatremic Patients With Cancer
- ClinicalTrials.gov ID
- NCT01199198
- Acronym / sponsor ID
- 2009-0862
- Conditions
- Advanced Cancers
- Keywords
- Hyponatremia, Serum sodium, Tolvaptan, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- May 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Sep 2010 (estimated)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Study Drug:
Tolvaptan is designed to help raise salt levels in your blood by removing extra body water as urine.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group:
- If you are in Group 1, you will take tolvaptan and receive standard of care
- If you are in Group 2, you will take a placebo and receive the standard of care for patients with hyponatremia. A placebo is a tablet that looks like the study drug but has no active ingredients.
You will not know which group you are assigned. However, if needed for your safety, you will be able to find out what you are receiving at any time.
Study Drug Administration:
You will take tolvaptan or the placebo 1 time every day by mouth for 14 days.
If you are receiving the placebo, you will also receive the standard of care for hyponatremia. Examples of the standard of care include limiting your water and fluid intake, or giving you salt tablets and other drugs such as diuretics. Your doctor will describe these in more detail.
You will be given a drug diary to record when you take the study drug/placebo. You will return any unused drug/placebo at the end of 14 days.
You should avoid grapefruit and grapefruit juice while you are taking tolvaptan.
Study Visits:
At every visit, you will be asked if you have had any side effects.
On Days 1, 2, and 3:
- Blood (about 1 teaspoon) will be drawn for routine tests. On Day 1, this sample will be drawn 2 times.
- Your weight and vital signs will be measured.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- You will be asked about any drugs that you may be taking.
- If the doctor thinks it is needed, you will have a physical exam.
On Day 7:
- Your medical history will be reviewed and updated.
- You will be asked about any drugs that you may be taking.
- Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
- Your weight and vital signs will be measured.
On Day 14:
- Your medical history will be reviewed and updated.
- Your weight and vital signs will be measured.
- Blood (about 1 teaspoon) and urine will be collected for routine tests and tests to measure how concentrated your blood and urine are.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- You will be asked about any drugs that you may be taking.
- You will complete the MMSE.
If the doctor thinks it is needed, you will have a physical exam.
Length of Study:
You will take the study drug/placebo for 14 days. You will be taken off study if you have intolerable side effects, if the disease gets worse, or if the study doctor thinks it is in your best interest.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study- Day 30 Follow-up Visit:
At 30 days after the last dose of study drug (or placebo), you will have an end-of-study visit in clinic or by telephone. At this visit, the following tests and procedures will be performed.
- Your medical history will be reviewed and updated.
- Blood (about 1 teaspoon) will be drawn for routine tests and tests to measure how concentrated your blood results are.
- You will be asked about any side effects that you may be having and any drugs that you may be taking.
- The study staff will record how much fluid you are drinking and how much you are urinating.
- If the doctor thinks it is needed, you will have a physical exam.
This is an investigational study. Tolvaptan is FDA approved and commercially available to treat hyponatremia (low levels of salt [sodium] in the blood due to too much body water). Its use in patients with cancer who have hyponatremia is investigational.
Up to 170 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolvaptan Group | Experimental | Drug: TolvaptanTolvaptan Group: Starting dose 15 mg by mouth once a day for 14 days. |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo Group: Placebo by mouth once a day for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolvaptanAlso: SamscaStarting dose 15 mg by mouth once a day for 14 days. | Drug | Tolvaptan Group |
| PlaceboAlso: Sugar PillPlacebo by mouth once a day for 14 days. | Drug | Placebo Group |
Primary outcome
Participants 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). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.
1 secondary outcome
Length of Stay in Hospital
Time frame: From administration of treatment to time of discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulla K. Salahudeen, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tolvaptan in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.