Trial · NCT01586624
A Phase I Trial of Vandetanib (AZD6474) and Selumetinib (AZD6244) for Solid Tumours Including Non Small Cell Lung Cancer (VanSel-1)
NCT01586624, Phase 1, Completed, Cancer Research UK; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Phase I Trial of Vandetanib (AZD6474) and Selumetinib (AZD6244) for Solid Tumours Including Non Small Cell Lung Cancer (VanSel-1). Trials, record NCT01586624. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01586624
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Trial of Vandetanib (AZD6474) and Selumetinib (AZD6244) for Solid Tumours Including Non Small Cell Lung Cancer (VanSel-1)
- NCT number
- NCT01586624
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 61 participants, actual
- Lead sponsor
- Cancer Research UK
- Conditions
- Cancer, Non Small Cell Lung Cancer
- Interventions
- Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib, Vandetanib, Selumetinib
- First posted
- 2012-04-27
- Last updated
- 2021-10-07
- Other registries' IDs
- eudract:2011-000627-33
- Results first posted
- 2021-10-07
- Limitations and caveats
61 patients were enrolled. 3 withdrew before having vandetanib (Van) or selumetinib (Sel). 1 patient in Cohort 5b received Van but withdrew before having Sel and was excluded from the safety analysis. The remaining 57 patients had at least 1 dose of the combination and were included in the safety analysis population (46 in dose escalation, 11 in expansion). PFS was planned to be assessed at 12 weeks but was instead assessed at 10 and 18 weeks as disease assessments were performed every 2 cycles
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). | Number of serious adverse events, non-serious adverse events and treatment emergent adverse events. |
| Primary | Number of Dose Limiting Toxicities (DLTs) Within Each Cohort. | DLTs occurring in the first Cycle (up to Day 42). | Number of DLTs within each cohort. |
| Secondary | Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Vandetanib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | Maximum observed plasma concentration of vandetanib post treatment with vandetanib alone and following the combination of vandetanib and selumetinib. |
| Secondary | Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | Maximum observed plasma concentration of selumetinib post treatment with the combination of vandetanib and selumetinib. |
| Secondary | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-24 Hours) of Vandetanib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | Area under the plasma concentration time curve (0-24 hours) of vandetanib post treatment with vandetanib alone and following the combination of vandetanib and selumetinib. |
| Secondary | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29. | Area under the plasma concentration time curve (0-12 hours) of selumetinib post treatment with the combination of vandetanib and selumetinib. This was extrapolated from the sampling data up to 10 hours to allow comparison with literature data. |
| Secondary | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of N-desmethyl Metabolite of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29. | Area under the plasma concentration time curve (0-12 hours) of N-desmethyl metabolite of selumetinib following the combination of vandetanib and selumetinib. This was extrapolated from the sampling data up to 10 hours to allow comparison with literature data. |
| Secondary | Expansion Cohort Only: Progression Free Survival (PFS) of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib. | 10 and 18 weeks from date of first dose of vandetanib. | PFS by Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0). Per RECIST for target lesions and assessed by computerised tomography (CT), progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum while on trial, or the appearance of one or more new lesions. |
| Secondary | Expansion Cohort Only: One Year Survival of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib. | 1 year from date of first dose of vandetanib. | Number of patients alive at one year. |
| Secondary | Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria. | Baseline, Day 12, Day 42. | Tumour metabolism using 18F-fluorodeoxyglucose positron emission tomography (\[18F\]FDG-PET) computerised tomography (CT) imaging pre and post treatment with vandetanib alone and following the combination of vandetanib and selumetinib. These were assessed and reported according to PERCIST criteria. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Safety data was collected from the date of written informed consent and continued until 28 days after the final administration of vandetanib and selumetinib, an average (mean) of 164 days (approximately 5.4 months). | All patients who met the eligibility criteria and received at least one dose of the combination treatment (vandetanib and selumetinib) were evaluable for safety assessment (N=57). | Adverse events | NUMBER |
| PRIMARY | Number of Dose Limiting Toxicities (DLTs) Within Each Cohort. | DLTs occurring in the first Cycle (up to Day 42). | All patients who met the eligibility criteria and received at least one dose of the combination treatment (vandetanib and selumetinib) were evaluable for safety assessment (N=57). | DLTs | NUMBER |
| SECONDARY | Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Vandetanib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data). | ng/mL | MEDIAN |
| SECONDARY | Dose Escalation Cohorts Only: PK Parameter Maximum Observed Plasma Concentration of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data). | ng/mL | MEDIAN |
| SECONDARY | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-24 Hours) of Vandetanib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 24 hours post dose on Day 4. 0 hours (pre dose) and at 0.5, 2, 4, 6, 10 and 24 hours post dose on Days 15 and 29. | All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data). | h*ng/mL | MEDIAN |
| SECONDARY | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29. | All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data). | h*ng/mL | MEDIAN |
| SECONDARY | Dose Escalation Cohorts Only: PK Parameter Area Under the Plasma Concentration Time Curve (0-12 Hours) of N-desmethyl Metabolite of Selumetinib. | 0 hours (pre dose) and at 0.5, 2, 4, 6 and 10 hours post dose on Days 15 and 29. | All patients in the dose escalation cohorts (Cohorts 1 to 6) who received at least one dose of IMP (N=47 with available PK data). | h*ng/mL | MEDIAN |
| SECONDARY | Expansion Cohort Only: Progression Free Survival (PFS) of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib. | 10 and 18 weeks from date of first dose of vandetanib. | All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9).~\*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1. | participants | NUMBER |
| SECONDARY | Expansion Cohort Only: One Year Survival of Patients With NSCLC After Treatment With the Combination of Vandetanib and Selumetinib. | 1 year from date of first dose of vandetanib. | All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9).~\*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1. | participants | NUMBER |
| SECONDARY | Expansion Cohort Only: Tumour Metabolism in Patients With NSCLC Using Positron Emission Tomography Response Criteria in Solid Tumours (PERCIST) Criteria. | Baseline, Day 12, Day 42. | All patients in the expansion cohort receiving at least one cycle\* of the vandetanib and selumetinib combination with a baseline assessment of disease (N=9).~\*To be evaluable for response, a patient must have received a minimum of 21 of the 28 daily doses of the combination treatment in Cycle 1. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group128
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | Total SAEs | 10 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | Total SAEs | 11 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib) | Total SAEs | 13 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib) | Total SAEs | 5 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib) | Total SAEs | 28 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | Total SAEs | 10 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib) | Total SAEs | 14 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | Total SAEs | 14 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | Total NSAEs | 99 | Adverse events | |
| Number of Serious Adverse Events, Non-serious Adverse Events and Treatment Emergent Adverse Events. | Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | Total NSAEs | 90 | Adverse events |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 6 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 6 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib) | 6 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib) | 7 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib) | 9 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 8 | |
| Overall Study | STARTED | Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib) | 8 | |
| Overall Study | STARTED | Dose Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 11 | |
| Overall Study | COMPLETED | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 2 | |
| Overall Study | COMPLETED | Dose Escalation Phase Cohort 2 (Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 2 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,560
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 | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib) | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib) | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib) | 1 | 6 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 0 | 11 | |
| other | Chest pain - cardiac | Cardiac disorders | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 1 | 6 | 1 |
| other | Chest pain - cardiac | Cardiac disorders | Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 0 | 6 |
1 to 10 of 1,560Source ClinicalTrials.gov
See all 1,560 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 0 | 6 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 1 | 6 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 3 (Steady State Dose of 100 mg OD Vandetanib + 75 mg BD Selumetinib) | 2 | 6 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 4 (Steady State Dose of 100 mg OD Vandetanib + 100 mg OD Selumetinib) | 0 | 7 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 5a (Steady State Dose of 100 mg OD Vandetanib + 125 mg OD Selumetinib) | 1 | 8 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 5b (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 0 | 7 |
| Total, all-cause mortality | Dose Escalation Phase Cohort 6 (Steady State Dose of 300 mg OD Vandetanib + 50 mg BD Selumetinib) | 1 | 6 |
| Total, all-cause mortality | Expansion Phase (Steady State Dose of 200 mg OD Vandetanib + 50 mg BD Selumetinib) | 7 | 11 |
| Total, other adverse events | Dose Escalation Phase Cohort 1 (Steady State Dose of 100 mg OD Vandetanib + 25 mg BD Selumetinib) | 6 | 6 |
| Total, other adverse events | Dose Escalation Phase Cohort 2 ( Steady State Dose of 100 mg OD Vandetanib + 50 mg BD Selumetinib) | 6 | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
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/NCT01586624
GET https://conductscience.org/api/trials/v1/NCT01586624/results?page=2