Trial · NCT01831726
Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
NCT01831726, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2017-03-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib. Trials, record NCT01831726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01831726
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
- NCT number
- NCT01831726
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Tumor Pathway Activations Inhibited by Dovitinib
- Interventions
- Dovitinib (TKI258)
- First posted
- 2013-04-15
- Last updated
- 2017-03-20
- Results first posted
- 2017-03-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) | Week 16 | CBR determined by investigator assessment for each tumor assessment \& defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,\& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1 |
| Secondary | Overall Response (OR) of Partial Response (PR) or Greater | Week 16 | Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR |
| Secondary | Progression-Free Survival (PFS) | 36 months | Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause. |
| Secondary | Overall Survival (OS) | 36 months | Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Benefit Rate (CBR) | Week 16 | Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints. | number of participants | NUMBER |
| SECONDARY | Overall Response (OR) of Partial Response (PR) or Greater | Week 16 | Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints. | number of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | 36 months | Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 36 months | Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints. | months | MEDIAN |
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 |
|---|---|---|---|---|---|
| Clinical Benefit Rate (CBR) | TKI258 | Complete response (CR) | 0 | number of participants | |
| Clinical Benefit Rate (CBR) | TKI258 | Partial response (PR) | 1 | number of participants | |
| Clinical Benefit Rate (CBR) | TKI258 | Stable disease (SD) | 10 | number of participants | |
| Clinical Benefit Rate (CBR) | TKI258 | Clinical benefit rate (CBR) | 11 | number of participants | |
| Overall Response (OR) of Partial Response (PR) or Greater | TKI258 | Complete response (CR) | 0 | number of participants | |
| Overall Response (OR) of Partial Response (PR) or Greater | TKI258 | Partial response (PR) | 1 | number of participants | |
| Overall Response (OR) of Partial Response (PR) or Greater | TKI258 | Overall response rate (ORR) | 1 | number of participants | |
| Progression-Free Survival (PFS) | TKI258 | 2.4 | 95% Confidence Interval 1.8 to 3.7 | months | |
| Overall Survival (OS) | TKI258 | 13.5 | 95% Confidence Interval 5.9 to 14.7 | months |
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 | TKI258 | 80 | |
| Overall Study | COMPLETED | TKI258 | 0 | |
| Overall Study | NOT COMPLETED | TKI258 | 80 |
Source ClinicalTrials.gov
Adverse events117
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 | Anaemia | Blood and lymphatic system disorders | TKI258 | 8 | 80 | |
| other | Lymphopenia | Blood and lymphatic system disorders | TKI258 | 4 | 80 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TKI258 | 8 | 80 | |
| other | Sinus tachycardia | Cardiac disorders | TKI258 | 4 | 80 | |
| other | Lacrimation increased | Eye disorders | TKI258 | 5 | 80 | |
| other | Abdominal pain | Gastrointestinal disorders | TKI258 | 12 | 80 | |
| other | Abdominal pain upper | Gastrointestinal disorders | TKI258 | 4 | 80 | |
| other | Constipation | Gastrointestinal disorders | TKI258 | 26 | 80 | |
| other | Diarrhoea | Gastrointestinal disorders | TKI258 | 51 | 80 | |
| other | Dry mouth | Gastrointestinal disorders | TKI258 | 6 | 80 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TKI258 | ||
| Total, other adverse events | TKI258 | 78 | 80 |
| Total, serious adverse events | TKI258 | 32 | 80 |
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/NCT01831726
GET https://conductscience.org/api/trials/v1/NCT01831726/events?page=2