Trial · NCT01240590
A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
NCT01240590, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC). Trials, record NCT01240590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01240590
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Trial of Crolibulin (EPC2407) Plus Cisplatin in Adults With Solid Tumors With a Focus on Anaplastic Thyroid Cancer (ATC)
- NCT number
- NCT01240590
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Solid Tumor, Anaplastic Thyroid Cancer
- Interventions
- Crolibulin, Cisplatin
- First posted
- 2010-11-15
- Last updated
- 2017-04-10
- Results first posted
- 2015-12-31
- Limitations and caveats
- The phase II portion was not completed because it was impossible to recruit.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Cisplatin (Phase I) | 3 weeks | MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE). |
| Primary | Maximum Tolerated Dose (MTD) of Crolibulin (Phase I) | 3 weeks | MTD is defined as the dose level immediately preceding the dose level at which 2 dose limiting toxicities (DLT) occurred. A DLT is defined as a hematologic or non-hematologic adverse event judged to be possibly, probably, or definitely related to cisplatin per the Common Terminology Criteria in Adverse Events (CTCAE). |
| Primary | Progression Free Survival (Phase II) | 6 weeks | Progression free survival (PFS) is defined as the duration of time from start of study treatment to time of progression. Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as: Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Primary | Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | 4 years, 6 months and 26 days | Here is the number of participants with serious and non-serious adverse events. For a detailed list of adverse events, see the adverse event module. |
| Secondary | Number of Participants Who Underwent Medically-Necessary Interventions | 4.5 years | Enrolled participants who had surgical procedures deemed medically necessary for their clinical care. |
| Secondary | Tumor Growth Rate Constant | 21 days | Difference in time (days) required for the treated tumors to reach a predetermined target size. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Cisplatin (Phase I) | 3 weeks | mg/m^2 | NUMBER | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Crolibulin (Phase I) | 3 weeks | mg/m^2 | NUMBER | |
| PRIMARY | Progression Free Survival (Phase II) | 6 weeks | The outcome was not met because the patients died and were not scanned before their death. | ||
| PRIMARY | Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | 4 years, 6 months and 26 days | participants | NUMBER | |
| SECONDARY | Number of Participants Who Underwent Medically-Necessary Interventions | 4.5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tumor Growth Rate Constant | 21 days | This outcome measure was not analyzed because few if any re-assessments were done, thus there was not enough data to assess the growth rate constant on the patients. |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Cisplatin (Phase I) | All Participants | 100 | mg/m^2 | ||
| Maximum Tolerated Dose (MTD) of Crolibulin (Phase I) | All Participants | 20 | mg/m^2 | ||
| Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | Ph I Level 1: Cisplatin + Crolibulin | 6 | participants | ||
| Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | Ph I Level 2: Cisplatin + Crolibulin | 1 | participants | ||
| Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | Ph II Level 3: Cisplatin + Crolibulin | 16 | participants | ||
| Number of Participants With Serious and Non-Serious Adverse Events (Phase I & II) | Ph II Level 4: Cisplatin | 1 | participants | ||
| Number of Participants Who Underwent Medically-Necessary Interventions | Ph I Level: -1 Cisplatin & Crolibulin | Gastrostomy | 0 | Participants | |
| Number of Participants Who Underwent Medically-Necessary Interventions | Ph I Level: 1 Cisplatin & Crolibulin | Gastrostomy | 1 | Participants | |
| Number of Participants Who Underwent Medically-Necessary Interventions | Ph I Level: 2 Cisplatin & Crolibulin | Gastrostomy | 0 | Participants | |
| Number of Participants Who Underwent Medically-Necessary Interventions | Ph II Level: 3 Cisplatin & Crolibulin | Gastrostomy | 0 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Level -1: Cisplatin + Crolibulin | 0 | |
| Phase I | STARTED | Level 1: Cisplatin + Crolibulin | 6 | |
| Phase I | STARTED | Level 2: Cisplatin + Crolibulin | 3 | |
| Phase I | STARTED | Level 3: Cisplatin + Crolibulin | 0 | |
| Phase I | STARTED | Level 4: Cisplatin | 0 | |
| Phase I | COMPLETED | Level -1: Cisplatin + Crolibulin | 0 | |
| Phase I | COMPLETED | Level 1: Cisplatin + Crolibulin | 6 | |
| Phase I | COMPLETED | Level 2: Cisplatin + Crolibulin | 0 | |
| Phase I | COMPLETED | Level 3: Cisplatin + Crolibulin | 0 | |
| Phase I | COMPLETED | Level 4: Cisplatin | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events505
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 | Abdominal distension | Gastrointestinal disorders | Ph I Level: -1 Cisplatin & Crolibulin | 0 | 0 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Ph I Level: 1 Cisplatin & Crolibulin | 0 | 6 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Ph I Level: 2 Cisplatin & Crolibulin | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Ph II Level: 3 Cisplatin & Crolibulin | 1 | 17 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Ph II Level: 4 Cisplatin | 0 | 1 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ph I Level: -1 Cisplatin & Crolibulin | 0 | 0 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ph I Level: 1 Cisplatin & Crolibulin | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ph I Level: 2 Cisplatin & Crolibulin | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Ph II Level: 3 Cisplatin & Crolibulin | 1 | 17 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Ph II Level: 4 Cisplatin | 0 | 1 | 0 |
1 to 10 of 505Source ClinicalTrials.gov
See all 505 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ph I Level: -1 Cisplatin & Crolibulin | 0 | 0 |
| Total, all-cause mortality | Ph I Level: 1 Cisplatin & Crolibulin | 0 | 6 |
| Total, all-cause mortality | Ph I Level: 2 Cisplatin & Crolibulin | 0 | 3 |
| Total, all-cause mortality | Ph II Level: 3 Cisplatin & Crolibulin | 0 | 17 |
| Total, all-cause mortality | Ph II Level: 4 Cisplatin | 0 | 1 |
| Total, other adverse events | Ph I Level: -1 Cisplatin & Crolibulin | 0 | 0 |
| Total, other adverse events | Ph I Level: 1 Cisplatin & Crolibulin | 6 | 6 |
| Total, other adverse events | Ph I Level: 2 Cisplatin & Crolibulin | 1 | 3 |
| Total, other adverse events | Ph II Level: 3 Cisplatin & Crolibulin | 16 | 17 |
| Total, other adverse events | Ph II Level: 4 Cisplatin | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT01240590
GET https://conductscience.org/api/trials/v1/NCT01240590/results?page=2