Trial · NCT01100944
A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies
NCT01100944, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2016-11-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies. Trials, record NCT01100944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01100944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies
- NCT number
- NCT01100944
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Thymoma, Thymic Carcinoma
- Interventions
- PXD101with cisplatin+doxorubicin+cyclophosphamide
- First posted
- 2010-04-09
- Last updated
- 2017-08-10
- Results first posted
- 2016-11-15
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Belinostat | 2 years | The MTD is defined as the highest dose at which less than 2 out of 6 patients experienced a dose limiting toxicity (DLT). A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours. |
| Primary | Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | up to 122 months | A DLT is defined as grade 4 neutropenia lasting more than 7 days despite prophylactic or therapeutic use of granulocyte colony-stimulating factor (G-CSF), febrile neutropenia defined as absolute neutrophil count (ANC) less than 1000/mm(3) and temperature more than 38.5 degrees Celsius or 100.4 degrees Fahrenheit or life threatening sepsis, grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding during the first cycle of therapy. Any grade 3 or 4 non-hematologic toxicity was considered dose limiting with the following exceptions: grade 3 diarrhea lasting less than 48 hours, grade 3 nausea and/or vomiting lasting less than 48 hours, grade 3 electrolyte abnormalities lasting less than 48 hours, grade 3 creatinine elevation lasting less than 48 hours. |
| Primary | Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies | 43 months | Objective response rate is the number of participants with a best objective response of partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST) divided by the number of participants who had treatment. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | up to 122 months | Here is the number of participants with serious and non-serious adverse events. For a detailed list of events, see the adverse event module. |
| Secondary | Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient) | up to 122 months | Here are the number of patients with treatment -related grade 3 and 4 adverse events (highest grade per event per patient). |
| Secondary | Clinical Response | 43 months | Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Disease Control Rate (DCR) | 43 months | DCR is defined as stable disease (SD) + partial response (PR) + complete response (CR) per the Response Criteria in Solid Tumors (RECIST). |
| Secondary | Time to Response | From the first day of treatment until the date of first documented response, assessed up to 43 months | Time to response is the time between the first day of treatment until first date of response (complete response (CR) + partial response (PR)) (whichever is first recorded). |
| Secondary | Duration of Response | From the time of first response until date of progression, assessed up to 43 months | Duration of response is measured from the time measurement criteria (e.g. Response Evaluation Criteria in Solid Tumors (RECIST)) are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
| Secondary | Progression Free Survival (PFS) | Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months | Duration of time from start of treatment to time of progression or death whichever occurs first. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 Belinostat | 2 years | mg/m(2) | NUMBER | |
| PRIMARY | Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | up to 122 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies | 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events | up to 122 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment-related Grade 3 and 4 Adverse Events (Highest Grade Per Event Per Patient) | up to 122 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Response | 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. | percentage of participants | NUMBER |
| SECONDARY | Time to Response | From the first day of treatment until the date of first documented response, assessed up to 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. | days | MEDIAN |
| SECONDARY | Duration of Response | From the time of first response until date of progression, assessed up to 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable for response. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Start of treatment to time of disease progression or death whichever occurs first, assessed up to 43 months | One patient hospitalized for viral meningoencephalitis during the first cycle was not evaluable. The reason median was not reached is that patients with thymoma have a more indolent disease with a longer survival, therefore a longer duration of response. | months | MEDIAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group157
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 Belinostat | Phase I Dose Level 1 & Phase I Dose Level 2 | 1000 | mg/m(2) | ||
| Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | Phase I Dose Level 2 | Grade 3 Nausea | 2 | Participants | |
| Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | Phase I Dose Level 2 | Grade 3 Diarrhea | 2 | Participants | |
| Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | Phase I Dose Level 2 | Grade 4 Neutropenia | 2 | Participants | |
| Number of Participants With Grade 3 and 4 Dose Limiting Toxicity (DLT) at 2000mg/m(2) Belinostat | Phase I Dose Level 2 | Grade 4 Thrombocytopenia | 2 | Participants | |
Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies | Thymic Participants | 21 | 95% Confidence Interval 4.7 to 50.8 | percentage of participants | |
Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies | Thymoma Participants | 64 | 95% Confidence Interval 30.8 to 89.1 | percentage of participants | |
Objective Response Rate (Partial Response (PR) + Complete Response (CR) of Belinostat in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Patients With Advanced Thymic Malignancies | Thymic and Thymoma Participants | 40 | 95% Confidence Interval 21.1 to 61.3 | percentage of participants | |
| Number of Participants With Serious and Non-serious Adverse Events | All Participants | Serious | 20 | Participants | |
| Number of Participants With Serious and Non-serious Adverse Events | All Participants | Non-serious | 26 | Participants |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Phase 1 Dose Level 1 | STARTED | Belinostat 250mg/m(2) and Chemotherapy | 6 | |
| Dose Escalation Phase 1 Dose Level 1 | STARTED | Belinostat 500mg/m(2) and Chemotherapy | 0 | |
| Dose Escalation Phase 1 Dose Level 1 | STARTED | Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD) | 0 | |
| Dose Escalation Phase 1 Dose Level 1 | COMPLETED | Belinostat 250mg/m(2) and Chemotherapy | 2 | |
| Dose Escalation Phase 1 Dose Level 1 | COMPLETED | Belinostat 500mg/m(2) and Chemotherapy | 0 | |
| Dose Escalation Phase 1 Dose Level 1 | COMPLETED | Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD) | 0 | |
| Dose Escalation Phase 1 Dose Level 1 | NOT COMPLETED | Belinostat 250mg/m(2) and Chemotherapy | 4 | |
| Dose Escalation Phase 1 Dose Level 1 | NOT COMPLETED | Belinostat 500mg/m(2) and Chemotherapy | 0 | |
| Dose Escalation Phase 1 Dose Level 1 | NOT COMPLETED | Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD) | 0 | |
| Dose Escalation Phase 1 Dose Level 2 | STARTED | Belinostat 250mg/m(2) and Chemotherapy | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events129
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 | Activated partial thromboplastin time prolonged | Investigations | All Participants | 3 | 26 | 6 |
| other | Agitation | Psychiatric disorders | All Participants | 1 | 26 | 1 |
| other | Alanine aminotransferase increased | Investigations | All Participants | 10 | 26 | 26 |
| other | Alkaline phosphatase increased | Investigations | All Participants | 1 | 26 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | All Participants | 7 | 26 | 7 |
| other | Anemia | Blood and lymphatic system disorders | All Participants | 23 | 26 | 124 |
| other | Anorexia | Metabolism and nutrition disorders | All Participants | 15 | 26 | 18 |
| other | Anxiety | Psychiatric disorders | All Participants | 1 | 26 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | All Participants | 2 | 26 | 3 |
| other | Aspartate aminotransferase increased | Investigations | All Participants | 10 | 26 | 25 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 13 | 26 |
| Total, other adverse events | All Participants | 26 | 26 |
| Total, serious adverse events | All Participants | 20 | 26 |
Source ClinicalTrials.gov
Papers5
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/NCT01100944
GET https://conductscience.org/api/trials/v1/NCT01100944/registered?page=2