Trial · NCT02495103
Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
NCT02495103, Phase 1, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2021-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma. Trials, record NCT02495103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02495103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
- NCT number
- NCT02495103
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Renal Cell Carcinoma, Hereditary Leiomyomatosis, Renal Cell Cancer
- Interventions
- Vandetanib, Metformin, Vandetanib/Metformin
- First posted
- 2015-07-13
- Last updated
- 2021-01-26
- Results first posted
- 2021-01-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1 Component - Maximum Tolerated Dose (MTD) of Vandetanib and Metformin When Used in Combination in Patients With Metastatic Renal Cell Carcinoma (RCC) | 42 days after the last patient starts therapy. | MTD is the dose level at which no more than 1 of up to 6 patients experience dose limiting toxicity (DLT) during 1 cycle of treatment (42 days from the time the intended dose of metformin is reached for a given dose level), and the dose below that at which at least 2 (of ≤6) patients have DLT as a result of the experimental regimen. A DLT is defined as grade III or greater diarrhea leading to hospitalization or lasting \> 48 hours despite optimal anti-diarrheal medication; grade IV diarrhea despite optimal anti-diarrheal prophylaxis; grade III or greater nausea or vomiting despite optimal antiemetics; grade III hypertension that is not controlled (to 140/90 mmHg or below) despite optimal antihypertensive therapy; grade III elevated serum creatinine that cannot be corrected to grade 1 or better with hydration within 48 hours; and electrolyte abnormalities that cannot be corrected with medical management within 72 hours. |
| Primary | Phase 2 Component - Percentage of Participants With an Overall Response Rate Following Treatment With the Combination of Vandetanib and Metformin | Approximately 8 weeks after initiation of therapy, every 8 weeks thereafter for the first 32 weeks, and then every 12 weeks while on treatment | Percentage of participants with an overall response rate following treatment with the combination of vandetanib and metformin in patients with 1) advanced Renal Cell Carcinoma (RCC) associated with Hereditary leiomyomatosis and renal cell cancer (HLRCC) or Succinate Dehydrogenase (SDH), and 2) advanced sporadic/non-HLRCC Papillary Renal Cell Carcinoma assessed by the Response Evaluation Criteria in SOlid Tumors (RECIST) v1.1. |
| Secondary | Phase 2 Component - Progression Free Survival (PFS) | Time from start of treatment to time of progression or death, whichever occurs first | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was assessed by the and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. |
| Secondary | Phase 2 Component - Time to Progression (TTP) | Approximately 8 weeks after initiation of therapy, every 8 weeks thereafter for the first 32 weeks, and then every 12 weeks while on treatment | Time to progression is the time between the first day of treatment to the day of disease progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions. |
| Other | Phase 1 Component - Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Approximately 24 months | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for 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. |
| Other | Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT) | Cycle 1 or 42 days from the time the intended dose of metformin is reached for a given dose level | A DLT is defined as grade III or greater diarrhea leading to hospitalization or lasting \> 48 hours despite optimal anti-diarrheal medication; grade IV diarrhea despite optimal anti-diarrheal prophylaxis; grade III or greater nausea or vomiting despite optimal antiemetics; grade III hypertension that is not controlled (to 140/90 mmHg or below) despite optimal antihypertensive therapy; grade III elevated serum creatinine that cannot be corrected to grade 1 or better with hydration within 48 hours; and electrolyte abnormalities that cannot be corrected with medical management within 72 hours. |
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 | Phase 1 Component - Maximum Tolerated Dose (MTD) of Vandetanib and Metformin When Used in Combination in Patients With Metastatic Renal Cell Carcinoma (RCC) | 42 days after the last patient starts therapy. | mg | NUMBER | |
| PRIMARY | Phase 2 Component - Percentage of Participants With an Overall Response Rate Following Treatment With the Combination of Vandetanib and Metformin | Approximately 8 weeks after initiation of therapy, every 8 weeks thereafter for the first 32 weeks, and then every 12 weeks while on treatment | This outcome measure was not done because we did not enter the phase II portion of the study, thus this endpoint was not evaluated. Vandetanib is no longer available as Sanofi has decided not to provide additional drug. | ||
| SECONDARY | Phase 2 Component - Progression Free Survival (PFS) | Time from start of treatment to time of progression or death, whichever occurs first | This outcome measure was not done because we did not enter the phase II portion of the study, thus this endpoint was not evaluated. Vandetanib is no longer available as Sanofi has decided not to provide additional drug. | ||
| SECONDARY | Phase 2 Component - Time to Progression (TTP) | Approximately 8 weeks after initiation of therapy, every 8 weeks thereafter for the first 32 weeks, and then every 12 weeks while on treatment | This outcome measure was not done because we did not enter the phase II portion of the study, thus this endpoint was not evaluated. Vandetanib is no longer available as Sanofi has decided not to provide additional drug. | ||
| OTHER_PRE_SPECIFIED | Phase 1 Component - Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Approximately 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT) | Cycle 1 or 42 days from the time the intended dose of metformin is reached for a given dose level | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1 Component - Maximum Tolerated Dose (MTD) of Vandetanib and Metformin When Used in Combination in Patients With Metastatic Renal Cell Carcinoma (RCC) | All Participants | NA | mg | ||
| Phase 1 Component - Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 3 | Participants | ||
| Phase 1 Component - Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 4 | Participants | ||
| Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT) | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | Participants | ||
| Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT) | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 0 | Participants |
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 | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 3 | |
| Overall Study | STARTED | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 4 | |
| Overall Study | COMPLETED | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 3 | |
| Overall Study | COMPLETED | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 4 | |
| Overall Study | NOT COMPLETED | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | |
| Overall Study | NOT COMPLETED | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 0 |
Source ClinicalTrials.gov
Adverse events136
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 pain | Gastrointestinal disorders | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 1 | 4 | 4 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | 3 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 1 | 4 | 1 |
| other | Alkaline phosphatase increased | Investigations | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 1 | 3 | 1 |
| other | Alkaline phosphatase increased | Investigations | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 2 | 4 | 4 |
| other | Alanine aminotransferase increased | Investigations | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Investigations | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 1 | 4 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 1 | 4 | 1 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 0 | 3 |
| Total, all-cause mortality | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 0 | 4 |
| Total, other adverse events | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 3 | 3 |
| Total, other adverse events | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 4 | 4 |
| Total, serious adverse events | Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily | 1 | 3 |
| Total, serious adverse events | Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily | 2 | 4 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: Phase 1 Component - Number of Participants With a Dose Limiting Toxicity (DLT) | Trial comparisons |
Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: Phase 1 Component - Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Trial comparisons |
| Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: deaths from any cause | Trial comparisons |
| Phase I, Dose Level 1 - Metformin 250mg Daily/Vandetanib 300mg Daily vs Phase I, Dose Level 2 - Metformin 250mg Twice Daily/Vandetanib 300mg Daily: 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/NCT02495103
GET https://conductscience.org/api/trials/v1/NCT02495103/events?page=2