Trial · NCT01650350
Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
NCT01650350, Phase 2, Terminated, Brown University; results first posted 2015-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer. Trials, record NCT01650350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01650350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer
- NCT number
- NCT01650350
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Brown University
- Conditions
- Melanoma, Prostate Cancer, Renal Cancer
- Interventions
- Naltrexone
- First posted
- 2012-07-26
- Last updated
- 2022-03-04
- Results first posted
- 2015-07-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | approximately every 3 months CT, every month physical, up to 6 months | Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks). |
| Secondary | To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer. | 3 months | Defined by number of patients who experienced a SAE |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | approximately every 3 months CT, every month physical, up to 6 months | participants | NUMBER | |
| SECONDARY | To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer. | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Melanoma: Low Dose Naltrexone | stable disease by RECIST | 0 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Prostate Cancer- Low Dose Naltrexone | stable disease by RECIST | 2 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Melanoma: Low Dose Naltrexone | progression of disease by PSA | 0 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Prostate Cancer- Low Dose Naltrexone | progression of disease by PSA | 6 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Melanoma: Low Dose Naltrexone | progression via RECIST | 0 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Prostate Cancer- Low Dose Naltrexone | progression via RECIST | 1 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Melanoma: Low Dose Naltrexone | progression clinical | 1 | participants | |
| Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST | Prostate Cancer- Low Dose Naltrexone | progression clinical | 0 | participants | |
| To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer. | Low Dose Naltrexone | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Naltrexone | 7 | |
| Overall Study | COMPLETED | Low Dose Naltrexone | 7 | |
| Overall Study | NOT COMPLETED | Low Dose Naltrexone | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Investigations | Low Dose Naltrexone | 4 | 7 | 4 |
| other | RBC | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | infection | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | abd pain | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | kidney pain | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | fatigue | Investigations | Low Dose Naltrexone | 3 | 7 | 3 |
| other | anorexia | Investigations | Low Dose Naltrexone | 2 | 7 | 2 |
| other | nausea | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | upset stomach | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
| other | diarrhea | Investigations | Low Dose Naltrexone | 1 | 7 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Naltrexone | ||
| Total, other adverse events | Low Dose Naltrexone | 7 | 7 |
| Total, serious adverse events | Low Dose Naltrexone | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01650350
GET https://conductscience.org/api/trials/v1/NCT01650350/events?page=2