Trial · NCT00075504
Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
NCT00075504, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-09-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer. Trials, record NCT00075504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Triapine and Gemcitabine Hydrochloride in Gallbladder Cancer
- NCT number
- NCT00075504
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Stage II Gallbladder Cancer, Stage IIIA Gallbladder Cancer, Stage IIIB Gallbladder Cancer, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer
- Interventions
- triapine, gemcitabine
- First posted
- 2004-01-12
- Last updated
- 2015-09-28
- Results first posted
- 2015-09-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate According to RECIST Criteria | Up to 2 years | Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR. |
| Secondary | Progression Free Survival | Up to 2 years | PFS will be measured from the time of the patient's initial best response (PR or CR) until documented progression. |
| Secondary | Overall Survival | Up to 2 years |
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 | Response Rate According to RECIST Criteria | Up to 2 years | participants | NUMBER | |
| SECONDARY | Progression Free Survival | Up to 2 years | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 2 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate According to RECIST Criteria | Stratum A Normal Liver Function Triapine, Gemcitabine | 3 | participants | ||
| Response Rate According to RECIST Criteria | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 0 | participants | ||
| Progression Free Survival | Stratum A Normal Liver Function Triapine, Gemcitabine | 3.7 | 95% Confidence Interval 2.7 to 5.8 | months | |
| Progression Free Survival | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 3.6 | 95% Confidence Interval 1.9 to 11.6 | months | |
| Overall Survival | Stratum A Normal Liver Function Triapine, Gemcitabine | 10.3 | 95% Confidence Interval 5.9 to NA | months | |
| Overall Survival | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 3.6 | 95% Confidence Interval 2.1 to 26.2 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum A Normal Liver Function Triapine, Gemcitabine | 23 | |
| Overall Study | STARTED | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 10 | |
| Overall Study | COMPLETED | Stratum A Normal Liver Function Triapine, Gemcitabine | 14 | |
| Overall Study | COMPLETED | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 3 | |
| Overall Study | NOT COMPLETED | Stratum A Normal Liver Function Triapine, Gemcitabine | 9 | |
| Overall Study | NOT COMPLETED | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 7 |
Source ClinicalTrials.gov
Adverse events52
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 | Platelet count decreased | Investigations | Stratum A Normal Liver Function Triapine, Gemcitabine | 11 | 23 | 23 |
| other | Platelet count decreased | Investigations | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 4 | 10 | 10 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Stratum A Normal Liver Function Triapine, Gemcitabine | 2 | 23 | 2 |
| other | Hypocalcemia | Metabolism and nutrition disorders | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 3 | 10 | 3 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Stratum A Normal Liver Function Triapine, Gemcitabine | 5 | 23 | 5 |
| other | Hypoalbuminemia | Metabolism and nutrition disorders | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 4 | 10 | 4 |
| other | Lymphocyte count decreased | Investigations | Stratum A Normal Liver Function Triapine, Gemcitabine | 13 | 23 | 13 |
| other | Lymphocyte count decreased | Investigations | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 4 | 10 | 4 |
| other | Hemoglobin | Blood and lymphatic system disorders | Stratum A Normal Liver Function Triapine, Gemcitabine | 19 | 23 | 19 |
| other | Hemoglobin | Blood and lymphatic system disorders | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 6 | 10 | 6 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum A Normal Liver Function Triapine, Gemcitabine | ||
| Total, all-cause mortality | Stratum B Abnormal Liver Function Triapine, Gemcitabine | ||
| Total, other adverse events | Stratum A Normal Liver Function Triapine, Gemcitabine | 22 | 23 |
| Total, other adverse events | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 10 | 10 |
| Total, serious adverse events | Stratum A Normal Liver Function Triapine, Gemcitabine | 21 | 23 |
| Total, serious adverse events | Stratum B Abnormal Liver Function Triapine, Gemcitabine | 10 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20981545 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01CA062505 | Phase I Molecular and Clincal Pharmacodynamic Trials | NEWMAN, EDWARD M | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1994 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Stratum A Normal Liver Function Triapine, Gemcitabine vs Stratum B Abnormal Liver Function Triapine, Gemcitabine: Response Rate According to RECIST Criteria | Trial comparisons |
| Stratum A Normal Liver Function Triapine, Gemcitabine vs Stratum B Abnormal Liver Function Triapine, Gemcitabine: serious adverse events | 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/NCT00075504
GET https://conductscience.org/api/trials/v1/NCT00075504/events?page=2