Trial · NCT01364727
A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
NCT01364727, Phase 2, Completed, Heather Wakelee; results first posted 2017-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies. Trials, record NCT01364727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01364727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies
- NCT number
- NCT01364727
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Heather Wakelee
- Conditions
- Thymoma, Thymus Cancer, Thymic Carcinoma
- Interventions
- Amrubicin
- First posted
- 2011-06-02
- Last updated
- 2019-04-16
- Results first posted
- 2017-03-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 2 years | Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity. Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate. RECIST criteria define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * CR = Disappearance of all target lesions * PR = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria |
| Secondary | Median Progression-free Survival (PFS) | 2 years | Median Progression-free survival in patients with thymic malignancies treated with amrubicin |
| Secondary | Disease Control Rate (DCR) | 2 years | Disease control rate (DCR) is the sum of Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate , and is expressed here as the sum of the Overall Response Rate (ORR = CR + PR) plus the Stable Disease (SD) rate, ORR + SD. Response was assessed by the RECIST criteria, elaborated above. |
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 | Overall Response Rate (ORR) | 2 years | Includes those participants with Complete Response (CR) plus those with Partial Response (PR). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression-free Survival (PFS) | 2 years | Some participants (2) continue to survive without progression, although a median and the 95% confidence interval (95% CI) for the 33 participants have been defined. | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) | 2 years | Includes those participants with Complete Response (CR) plus those with Partial Response (PR), plus those with Stable Disease). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Amrubicin | Complete Response (CR) | 0 | Participants | |
| Overall Response Rate (ORR) | Amrubicin | Partial Response (PR) | 6 | Participants | |
| Overall Response Rate (ORR) | Amrubicin | Overall response rate (ORR) | 6 | Participants | |
| Median Progression-free Survival (PFS) | Amrubicin | 8.5 | 95% Confidence Interval 6.7 to 38.0 | Months | |
| Disease Control Rate (DCR) | Amrubicin | Overall Response Rate (ORR) | 6 | Participants | |
| Disease Control Rate (DCR) | Amrubicin | Stable Disease (SD) | 23 | Participants | |
| Disease Control Rate (DCR) | Amrubicin | Disease control rate (DCR) | 29 | 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 | Amrubicin | 35 | |
| Overall Study | COMPLETED | Amrubicin | 33 | |
| Overall Study | NOT COMPLETED | Amrubicin | 2 |
Source ClinicalTrials.gov
Adverse events121
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 pain | General disorders | Amrubicin | 5 | 33 | 6 |
| other | Alanine aminotransferase increased | Investigations | Amrubicin | 5 | 33 | 5 |
| other | Alkaline phosphatase increased | Investigations | Amrubicin | 5 | 33 | 5 |
| other | Allergic reaction | Immune system disorders | Amrubicin | 4 | 33 | 4 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Amrubicin | 15 | 33 | 15 |
| other | Anemia | Blood and lymphatic system disorders | Amrubicin | 32 | 33 | 32 |
| other | Anorectal infection | Infections and infestations | Amrubicin | 3 | 33 | 3 |
| other | Anorexia | Gastrointestinal disorders | Amrubicin | 16 | 33 | 16 |
| other | Anxiety | Psychiatric disorders | Amrubicin | 3 | 33 | 3 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Amrubicin | 1 | 33 | 1 |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amrubicin | ||
| Total, other adverse events | Amrubicin | 33 | 33 |
| Total, serious adverse events | Amrubicin | 16 | 33 |
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/NCT01364727
GET https://conductscience.org/api/trials/v1/NCT01364727/events?page=2