Trial · NCT00072189
A Phase II Study of UCN-01 in Metastatic Melanoma
NCT00072189, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2015-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Study of UCN-01 in Metastatic Melanoma. Trials, record NCT00072189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00072189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Study of UCN-01 in Metastatic Melanoma
- NCT number
- NCT00072189
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Melanoma, Stage IV Melanoma
- Interventions
- 7-hydroxystaurosporine, laboratory biomarker analysis, pharmacological study
- First posted
- 2003-11-06
- Last updated
- 2015-03-02
- Results first posted
- 2015-03-02
- Limitations and caveats
- Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Up to 7 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Secondary | Overall Survival | Up to 7 years | Estimated using the product-limit method of Kaplan and Meier. |
| Secondary | Progression-free Survival | From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years | Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Up to 7 years | percentage of responding participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 7 years | months | MEDIAN | |
| SECONDARY | Progression-free Survival | From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate | Arm 1 | 0 | percentage of responding participants | ||
| Overall Survival | Arm 1 | 7.3 | 95% Confidence Interval 3.4 to 18.4 | months | |
| Progression-free Survival | Arm 1 | 1.3 | 95% Confidence Interval 1.2 to 3.0 | months |
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 | Arm 1 | 17 | |
| Overall Study | COMPLETED | Arm 1 | 16 | |
| Overall Study | NOT COMPLETED | Arm 1 | 1 |
Source ClinicalTrials.gov
Adverse events74
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Arm 1 | 7 | 17 | 16 |
| other | Packed red blood cell transfusion | Blood and lymphatic system disorders | Arm 1 | 2 | 17 | 2 |
| other | Arrhythmia supraventricular | Cardiac disorders | Arm 1 | 1 | 17 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Arm 1 | 2 | 17 | 2 |
| other | Hearing loss | Ear and labyrinth disorders | Arm 1 | 1 | 17 | 5 |
| other | Middle ear inflammation | Ear and labyrinth disorders | Arm 1 | 1 | 17 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Arm 1 | 3 | 17 | 4 |
| other | Constipation | Gastrointestinal disorders | Arm 1 | 2 | 17 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Arm 1 | 2 | 17 | 2 |
| other | Dyspepsia | Gastrointestinal disorders | Arm 1 | 1 | 17 | 1 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, other adverse events | Arm 1 | 17 | 17 |
| Total, serious adverse events | Arm 1 | 7 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20967484 | DERIVED |
Source PubMed
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/NCT00072189
GET https://conductscience.org/api/trials/v1/NCT00072189/events?page=2