Trial · NCT00911443
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
NCT00911443, Phase 2, Completed, sigma-tau i.f.r. S.p.A.; results first posted 2009-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma. Trials, record NCT00911443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00911443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
- NCT number
- NCT00911443
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 488 participants, actual
- Lead sponsor
- sigma-tau i.f.r. S.p.A.
- Conditions
- Malignant Melanoma
- Interventions
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg, Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg, Dacarbazine + Thymosin-alpha-1 3.2 mg, Dacarbazine + Interferon alpha
- First posted
- 2009-06-02
- Last updated
- 2009-07-09
- Results first posted
- 2009-06-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Tumor Response | 1 year | Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response |
| Secondary | Overall Survival | 2 years | The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored. |
| Secondary | Progression Free Survival | 2 years | Progression Free Survival is defined as the time from the randomization to progression or death |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Survival | 2 years | months | MEDIAN | |
| SECONDARY | Progression Free Survival | 2 years | months | MEDIAN | |
| PRIMARY | Overall Tumor Response | 1 year | participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | 9.3 | 95% Confidence Interval 8.0 to 11.1 | months | |
| Overall Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg | 8.6 | 95% Confidence Interval 6.1 to 11.6 | months | |
| Overall Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | 10.3 | 95% Confidence Interval 8.2 to 12.7 | months | |
| Overall Survival | Dacarbazin + Thymosin-alpha-1 3.2 mg | 9.3 | 95% Confidence Interval 6.7 to 11.7 | months | |
| Overall Survival | Dacarbazin + Interferon Alpha | 6.6 | 95% Confidence Interval 5.3 to 9.9 | months | |
| Progression Free Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | 1.9 | 95% Confidence Interval 1.8 to 2.6 | months | |
| Progression Free Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg | 1.8 | 95% Confidence Interval 1.8 to 2.0 | months | |
| Progression Free Survival | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | 1.8 | 95% Confidence Interval 1.8 to 2.6 | months | |
| Progression Free Survival | Dacarbazin + Thymosin-alpha-1 3.2 mg | 2.0 | 95% Confidence Interval 1.8 to 3.5 | months | |
| Progression Free Survival | Dacarbazin + Interferon Alpha | 1.8 | 95% Confidence Interval 1.7 to 2.0 | months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | 97 | |
| Overall Study | STARTED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg | 97 | |
| Overall Study | STARTED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | 98 | |
| Overall Study | STARTED | Dacarbazin + Thymosin-alpha-1 3.2 mg | 99 | |
| Overall Study | STARTED | Dacarbazin + Interferon Alpha | 97 | |
| Overall Study | COMPLETED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | 97 | |
| Overall Study | COMPLETED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg | 97 | |
| Overall Study | COMPLETED | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | 98 | |
| Overall Study | COMPLETED | Dacarbazin + Thymosin-alpha-1 3.2 mg | 99 | |
| Overall Study | COMPLETED | Dacarbazin + Interferon Alpha | 97 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT00911443
GET https://conductscience.org/api/trials/v1/NCT00911443/registered