Trial · NCT01006252
A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
NCT01006252, Phase 3, Terminated, Eli Lilly and Company; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma. Trials, record NCT01006252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01006252
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tasisulam-sodium Versus Paclitaxel as Treatment for Metastatic Melanoma
- NCT number
- NCT01006252
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Melanoma
- Interventions
- Tasisulam-sodium, Paclitaxel
- First posted
- 2009-11-02
- Last updated
- 2018-07-17
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months | OS is duration from enrollment to death; OS censored for participants who were alive at last contact. |
| Secondary | Progression Free Survival (PFS) | Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months | PFS is time from date of first dose to first observation of disease progression (PD); PD=20% increase in sum of the longest diameter of target lesions, or death from any cause. |
| Secondary | Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months | Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. |
| Secondary | Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR) | First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; Progressive disease (PD)=20% increase in sum of the longest diameter of target lesions. Analysis was adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group. Due to limited number of responses for either treatment arm, DoR analysis was not performed. |
| Secondary | Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD) | First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months | Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria; PD=20% increase in sum of the longest diameter of target lesions. |
| Secondary | Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score | Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months | FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. FACT-M TOI is the sum of FACT-M physical well-being, functional well-being, and melanoma subscales. Scores range from 0 to 120; Higher scores=better quality of life (QoL). FACT-M TOI score deterioration was defined as time from randomization to a minimally important difference in TOI score or death. |
| Secondary | Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 2, up to 30 days following treatment discontinuation | FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy. |
| Secondary | Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 3, up to 30 days following treatment discontinuation | FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy. |
| Secondary | Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 4, up to 30 days following treatment discontinuation | FACT-M measures domains of health-related quality of life (HR-QoL): physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns of melanoma. Total scores range from 0 to 172; Higher scores=better HR-QoL. Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy. |
| Secondary | Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 2, up to 30 days following treatment discontinuation | EQ-5D consists of 5 items that assess participant's overall health. Participants choose 1 of 3 options that best describe the status of each item. EQ-5D United Kingdom (UK)-based index scores range from -0.59 (worst health) to 1.0 (1.0=perfect health; Positive change from baseline=health improvement). Least Squares (LS) Mean value was adjusted for treatment group, cycle, treatment-by-cycle interaction, age, Eastern Cooperative Oncology Group (ECOG) performance status, stage of disease at study entry, and best response to previous chemotherapy. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months | The intent-to-treat (ITT) analysis population included all participants randomized to treatment. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Randomization to date of objectively determined PD, or death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 13.70 months | The intent-to-treat (ITT) analysis population included all participants randomized to treatment. | months | MEDIAN |
| SECONDARY | Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months | The intent-to-treat (ITT) analysis population included all participants randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) for Participants Having an Objective Response of Partial Response (PR) or Complete Response (CR) | First date RECIST criteria met for CR or PR (whichever occurred first) until first date of documented PD, or death from any cause (assessed every other cycle) up to 13.70 months | Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis per study report. | ||
| SECONDARY | Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD) | First date RECIST criteria met for CR, PR, or SD until first date of documented progressive disease (PD), or death from any cause (assessed every other cycle) up to 13.70 months | The intent-to-treat (ITT) analysis population included all participants randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Time to Deterioration in the Functional Assessment of Cancer Therapy-Melanoma Trial Outcome Index (FACT-M TOI) Score | Randomization to first date of deterioration in FACT-M TOI, or death from any cause (assessed every cycle and up to 30 days following treatment discontinuation) up to 13.21 months | The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement. | months | MEDIAN |
| SECONDARY | Change From Baseline at Cycle 2 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 2, up to 30 days following treatment discontinuation | The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Cycle 3 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 3, up to 30 days following treatment discontinuation | The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Cycle 4 in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 4, up to 30 days following treatment discontinuation | The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline at Cycle 2 in EuroQol-5 Dimensions (EQ-5D) up to 30 Days Following Treatment Discontinuation | Baseline at Cycle 2, up to 30 days following treatment discontinuation | The analysis population included all randomized participants who had baseline and at least 1 post-baseline measurement. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Tasisulam-sodium | 6.77 | 95% Confidence Interval 5.88 to 8.28 | months | |
| Overall Survival (OS) | Paclitaxel | 9.36 | 95% Confidence Interval 6.90 to NA | months | |
| Progression Free Survival (PFS) | Tasisulam-sodium | 1.94 | 95% Confidence Interval 1.87 to 2.04 | months | |
| Progression Free Survival (PFS) | Paclitaxel | 2.14 | 95% Confidence Interval 1.91 to 2.96 | months | |
| Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | Tasisulam-sodium | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | Paclitaxel | CR | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | Tasisulam-sodium | PR | 3.0 | 95% Confidence Interval 0.4 to 5.5 | percentage of participants |
| Percentage of Randomized Participants Having a Confirmed Best Response of Partial Response (PR) or Complete Response (CR) | Paclitaxel | PR | 4.8 | 95% Confidence Interval 1.5 to 8.0 | percentage of participants |
| Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD) | Tasisulam-sodium | 30.4 | 95% Confidence Interval 23.4 to 37.3 | percentage of participants | |
| Percentage of Randomized Participants Having a Confirmed Best Overall Response of Partial Response (PR) or Complete Response (CR) Plus Participants With an Overall Response of Stable Disease (SD) | Paclitaxel | 33.9 | 95% Confidence Interval 26.8 to 41.1 | percentage of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tasisulam-sodium | 168 | |
| Overall Study | STARTED | Paclitaxel | 168 | |
| Overall Study | Received Treatment | Tasisulam-sodium | 164 | |
| Overall Study | Received Treatment | Paclitaxel | 161 | |
| Overall Study | COMPLETED | Tasisulam-sodium | 168 | |
| Overall Study | COMPLETED | Paclitaxel | 168 | |
| Overall Study | NOT COMPLETED | Tasisulam-sodium | 0 | |
| Overall Study | NOT COMPLETED | Paclitaxel | 0 |
Source ClinicalTrials.gov
Adverse events268
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 | Anaemia | Blood and lymphatic system disorders | Tasisulam-sodium | 15 | 164 | 17 |
| other | Anaemia | Blood and lymphatic system disorders | Paclitaxel | 19 | 161 | 21 |
| other | Neutropenia | Blood and lymphatic system disorders | Tasisulam-sodium | 13 | 164 | 17 |
| other | Neutropenia | Blood and lymphatic system disorders | Paclitaxel | 19 | 161 | 27 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tasisulam-sodium | 21 | 164 | 28 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Paclitaxel | 2 | 161 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Tasisulam-sodium | 12 | 164 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | Paclitaxel | 14 | 161 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | Tasisulam-sodium | 10 | 164 | 10 |
| other | Abdominal pain upper | Gastrointestinal disorders | Paclitaxel | 4 | 161 | 4 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tasisulam-sodium | ||
| Total, all-cause mortality | Paclitaxel | ||
| Total, other adverse events | Tasisulam-sodium | 149 | 164 |
| Total, other adverse events | Paclitaxel | 146 | 161 |
| Total, serious adverse events | Tasisulam-sodium | 53 | 164 |
| Total, serious adverse events | Paclitaxel | 44 | 161 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tasisulam-sodium vs Paclitaxel: serious adverse events |
Source Trial comparisons
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/NCT01006252
GET https://conductscience.org/api/trials/v1/NCT01006252/results?page=2