Trial · NCT00873119
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary
NCT00873119, Phase 2, Completed, Valerio Therapeutics; results first posted 2014-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary. Trials, record NCT00873119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00873119
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary
- NCT number
- NCT00873119
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Valerio Therapeutics
- Conditions
- Carcinoma of Unknown Primary
- Interventions
- belinostat, carboplatin, paclitaxel, carboplatin, paclitaxel
- First posted
- 2009-04-01
- Last updated
- 2015-07-28
- Results first posted
- 2014-12-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors). |
| Secondary | Best Overall Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR) |
| Secondary | Overall Survival (OS) | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Time from the date of randomization to the date of death |
| Secondary | Time to Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met |
| Secondary | Duration of Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD (\[Progressive Disease\]) or death was documented |
| Secondary | Time to Progression (TTP) | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Time from the date of randomization to the time of disease progression |
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 | Progression Free Survival | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy | months | MEDIAN |
| SECONDARY | Best Overall Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored. | months | MEDIAN |
| SECONDARY | Time to Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Patients with overall best response being either complete response or partial response. | months | MEDIAN |
| SECONDARY | Duration of Response | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Tumor assessment every 6 weeks for the treatment period. Subsequent assessments every 6 weeks for the initial 6 months, then every 9 weeks for 6 months, then every 12 weeks for 12 months and then every 6 months until 5 years from the start of study | Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Arm A - BelCaP | 5.4 | 95% Confidence Interval 3.0 to 6.0 | months | |
| Progression Free Survival | Arm B - CaP | 5.3 | 95% Confidence Interval 2.8 to 6.7 | months | |
| Best Overall Response | Arm A - BelCaP | 43.2 | percentage of participants | ||
| Best Overall Response | Arm B - CaP | 22.2 | percentage of participants | ||
| Overall Survival (OS) | Arm A - BelCaP | 11.5 | 95% Confidence Interval 6.9 to 18 | months | |
| Overall Survival (OS) | Arm B - CaP | 9.1 | 95% Confidence Interval 6.6 to 11 | months | |
| Time to Response | Arm A - BelCaP | 3.2 | Full Range 0 to 19.1 | months | |
| Time to Response | Arm B - CaP | NA | Full Range 0 to NA | months | |
| Duration of Response | Arm A - BelCaP | 4.6 | 95% Confidence Interval 3.3 to 8.3 | months | |
| Duration of Response | Arm B - CaP | 6.5 | 95% Confidence Interval 2.9 to 24.2 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A - BelCaP | 44 | |
| Overall Study | STARTED | Arm B - CaP | 45 | |
| Overall Study | COMPLETED | Arm A - BelCaP | 0 | |
| Overall Study | COMPLETED | Arm B - CaP | 19 | |
| Overall Study | NOT COMPLETED | Arm A - BelCaP | 44 | |
| Overall Study | NOT COMPLETED | Arm B - CaP | 26 |
Source ClinicalTrials.gov
Adverse events212
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 | Nausea | Gastrointestinal disorders | Arm A - BelCaP | 36 | 42 | |
| other | Nausea | Gastrointestinal disorders | Arm B - CaP | 26 | 44 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm A - BelCaP | 24 | 42 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm B - CaP | 17 | 44 | |
| other | Vomiting | Gastrointestinal disorders | Arm A - BelCaP | 26 | 42 | |
| other | Vomiting | Gastrointestinal disorders | Arm B - CaP | 13 | 44 | |
| other | Constipation | Gastrointestinal disorders | Arm A - BelCaP | 19 | 42 | |
| other | Constipation | Gastrointestinal disorders | Arm B - CaP | 18 | 44 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm A - BelCaP | 8 | 42 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm B - CaP | 11 | 44 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A - BelCaP | ||
| Total, all-cause mortality | Arm B - CaP | ||
| Total, other adverse events | Arm A - BelCaP | 42 | 42 |
| Total, other adverse events | Arm B - CaP | 43 | 44 |
| Total, serious adverse events | Arm A - BelCaP | 22 | 42 |
| Total, serious adverse events | Arm B - CaP | 10 | 44 |
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 |
|---|
| Arm A - BelCaP vs Arm B - CaP: 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/NCT00873119
GET https://conductscience.org/api/trials/v1/NCT00873119/events?page=2