Trial · NCT00978250
A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)
NCT00978250, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-12-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU). Trials, record NCT00978250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00978250
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)
- NCT number
- NCT00978250
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 95 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms
- Interventions
- 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
- First posted
- 2009-09-16
- Last updated
- 2019-12-27
- Results first posted
- 2019-12-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | until subject progressed or went off study for other reasons (up to approximately 1 year) | Progression-free survival (PFS) is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions. |
| Primary | Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | until subject progressed or went off study for other reasons (up to approximately 1 year) | Response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 109 months and 16 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
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 | Progression-free Survival (PFS) | until subject progressed or went off study for other reasons (up to approximately 1 year) | All 93 patients eligible for the study were assessed for PFS, including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug. | months | MEDIAN |
| PRIMARY | Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | until subject progressed or went off study for other reasons (up to approximately 1 year) | All 93 patients eligible for the study were assessed for complete response (CR) or partial response (PR), including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approximately 109 months and 16 days. | Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Non-Small Cell Cancer Stratum | 2.3 | 95% Confidence Interval 1.6 to 3.9 | months | |
| Progression-free Survival (PFS) | Breast Cancer Stratum | 3.7 | 95% Confidence Interval 1.8 to 5.3 | months | |
| Progression-free Survival (PFS) | Bladder Cancer Stratum | 3.6 | 95% Confidence Interval 1.7 to 8.0 | months | |
| Progression-free Survival (PFS) | Heand and Neck Cancer Stratum | 1.7 | 95% Confidence Interval 1.7 to 4.5 | months | |
| Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | Non-Small Cell Cancer Stratum | 0.0 | 95% Confidence Interval 0.0 to 13.7 | percentage of participants | |
| Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | Breast Cancer Stratum | 6.9 | 95% Confidence Interval 0.8 to 22.8 | percentage of participants | |
| Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | Bladder Cancer Stratum | 5.6 | 95% Confidence Interval 0.1 to 27.3 | percentage of participants | |
| Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd) | Head and Neck Cancer Stratum | 0.0 | 95% Confidence Interval 0.0 to 16.1 | percentage of participants | |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 91 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Small Cell Lung Cancer Stratum | 25 | |
| Overall Study | STARTED | Breast Cancer Stratum | 30 | |
| Overall Study | STARTED | Bladder Cancer Stratum | 18 | |
| Overall Study | STARTED | Head and Neck Cancer Stratum | 22 | |
| Overall Study | COMPLETED | Non-Small Cell Lung Cancer Stratum | 25 | |
| Overall Study | COMPLETED | Breast Cancer Stratum | 29 | |
| Overall Study | COMPLETED | Bladder Cancer Stratum | 18 | |
| Overall Study | COMPLETED | Head and Neck Cancer Stratum | 21 | |
| Overall Study | NOT COMPLETED | Non-Small Cell Lung Cancer Stratum | 0 | |
| Overall Study | NOT COMPLETED | Breast Cancer Stratum | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events288
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 | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 3 | 93 | 6 |
| other | Abdominal infection | Infections and infestations | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 1 | 93 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 20 | 93 | 34 |
| other | Activated partial thromboplastin time prolonged | Investigations | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 12 | 93 | 13 |
| other | Agitation | Psychiatric disorders | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 1 | 93 | 1 |
| other | Alanine aminotransferase increased | Investigations | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 34 | 93 | 83 |
| other | Alkaline phosphatase increased | Investigations | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 26 | 93 | 49 |
| other | Allergic reaction | Immune system disorders | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 1 | 93 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 2 | 93 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 2 | 93 | 2 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 8 | 93 |
| Total, other adverse events | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 91 | 93 |
| Total, serious adverse events | 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU) | 38 | 93 |
Source ClinicalTrials.gov
Papers3
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/NCT00978250
GET https://conductscience.org/api/trials/v1/NCT00978250/events?page=2