Trial · NCT00843037
Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
NCT00843037, Phase 2, Completed, University Health Network, Toronto; results first posted 2024-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma. Trials, record NCT00843037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00843037
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Sunitinib In Patients With Recurrent Paraganglioma/Pheochromocytoma
- NCT number
- NCT00843037
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Paraganglioma, Pheochromocytoma
- Interventions
- Sunitinib
- First posted
- 2009-02-13
- Last updated
- 2024-10-17
- Results first posted
- 2024-10-17
- Limitations and caveats
Some patients did not have genetic testing and this trial is not able to define prognostic or predictive biomarkers due to small numbers; genetic panel testing varied between institutions and during study period; plasma metanephrine analysis not performed throughout study; only total and not fractionated urinary metanephrines were available; incomplete biochemical interpretation; some standard practices now were not integrated when study initiated in May 2009
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Benefit Rate (CBR) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | The primary endpoint of this study was disease control rate (DCR) defined as a partial response (PR), complete response (CR), or stable disease maintained for ≥12 weeks from the initiation of treatment. Tumour response to sunitinib was assessed as per RECIST 1.1 using CT-imaging. Clinically apparent lesions needed to be \>10mm by calliper measurement to be included as targets. The primary endpoint was met despite closing to accrual early. |
| Secondary | Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Within 7 days of study registration and every 12 weeks (2 cycles) up to treatment discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Biochemical and symptom changes: timed urinary catecholamine collection over 24 h included measurements of norepinephrine, epinephrine, dopamine and total metanephrines. |
| Secondary | Overall Survival | From time of enrollment until loss to follow-up or death (approximately 125 months for longest patient on treatment). | The median overall survival |
| Secondary | Time to Progression | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Median Progression-Free Survival (PFS) |
| Secondary | Overall Response Rate (PR) + (CR) | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Overall response rate (PR) + (CR) of participants |
Source ClinicalTrials.gov
Outcomes5
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) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Twenty-three patients were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Within 7 days of study registration and every 12 weeks (2 cycles) up to treatment discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Includes patients that had F/U measurements. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From time of enrollment until loss to follow-up or death (approximately 125 months for longest patient on treatment). | months | MEDIAN | |
| SECONDARY | Time to Progression | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | Includes patients that had a PFS event (up to 31 Jan 2018). | months | MEDIAN |
| SECONDARY | Overall Response Rate (PR) + (CR) | Every 12 weeks (2 cycles) up to disease progression or study discontinuation (an average of 13.5 6-week cycles or about 1.5 years). | 23 evaluable for response data | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
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) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. | Single-Arm, Open Label - Sunitinib | CR, PR, SD > 12 weeks | 19 | Participants | |
Clinical Benefit Rate (CBR) Which is Defined as Either a Partial Response (PR) Complete Response (CR) or Stable Disease (SD) for ≥ 12 Weeks Measured Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. | Single-Arm, Open Label - Sunitinib | Not CR, PR, SD > 12 weeks | 4 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | 24-h urinary metanephrines / BCR >20% decline in values > 12 weeks | 7 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | 24-h urinary metanephrines / No BCR >20% decline in values > 12 weeks | 5 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | norepinephrine / BCR >20% decline in values > 12 weeks | 7 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | norepinephrine / No BCR >20% decline in values > 12 weeks | 5 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | Epinephrine / BCR >20% decline in values > 12 weeks | 4 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | Epinephrine / No BCR >20% decline in values > 12 weeks | 1 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | Dopamine / BCR >20% decline in values > 12 weeks | 3 | Participants | |
| Biochemical Response (BCR) of > 20% Drop in 24-hour Urinary Metanephrines, Catecholamines or Serum Chromogranin A, Sustained for > 12-week Period | Single-Arm, Open Label - Sunitinib | Dopamine / No BCR >20% decline in values > 12 weeks | 2 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single-Arm, Open Label - Sunitinib | 25 | |
| Overall Study | COMPLETED | Single-Arm, Open Label - Sunitinib | 24 | |
| Overall Study | NOT COMPLETED | Single-Arm, Open Label - Sunitinib | 1 |
Source ClinicalTrials.gov
Adverse events38
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 | Fatigue | General disorders | Single-Arm, Open Label - Sunitinib | 17 | 25 | 48 |
| other | Nausea/Vomiting | Gastrointestinal disorders | Single-Arm, Open Label - Sunitinib | 16 | 25 | 64 |
| other | palmar-plantar erythrodysesthesia (PPES) | Skin and subcutaneous tissue disorders | Single-Arm, Open Label - Sunitinib | 16 | 25 | 56 |
| other | Diarrhea | Gastrointestinal disorders | Single-Arm, Open Label - Sunitinib | 11 | 25 | 31 |
| other | Hypertension | Vascular disorders | Single-Arm, Open Label - Sunitinib | 11 | 25 | 23 |
| other | Mucositis | Gastrointestinal disorders | Single-Arm, Open Label - Sunitinib | 10 | 25 | 12 |
| other | Dysgeusia | Nervous system disorders | Single-Arm, Open Label - Sunitinib | 7 | 25 | 12 |
| other | Anorexia | Metabolism and nutrition disorders | Single-Arm, Open Label - Sunitinib | 5 | 25 | 11 |
| other | Thrombocytopenia | Investigations | Single-Arm, Open Label - Sunitinib | 6 | 25 | 52 |
| other | AST/ALT increased | Investigations | Single-Arm, Open Label - Sunitinib | 3 | 25 | 11 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single-Arm, Open Label - Sunitinib | 1 | 25 |
| Total, other adverse events | Single-Arm, Open Label - Sunitinib | 25 | 25 |
| Total, serious adverse events | Single-Arm, Open Label - Sunitinib | 10 | 25 |
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/NCT00843037
GET https://conductscience.org/api/trials/v1/NCT00843037/events?page=2