Trial · NCT01465659
Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery
NCT01465659, Phase 1, Phase 2, Completed, Northwestern University; results first posted 2020-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery. Trials, record NCT01465659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01465659
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Temozolomide and Pazopanib Hydrochloride in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors That Cannot Be Removed By Surgery
- NCT number
- NCT01465659
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Pancreatic Alpha Cell Carcinoma, Pancreatic Beta Islet Cell Carcinoma, Pancreatic Delta Cell Carcinoma, Pancreatic G-cell Carcinoma, Recurrent Islet Cell Carcinoma
- Interventions
- temozolomide, pazopanib hydrochloride
- First posted
- 2011-11-07
- Last updated
- 2021-08-05
- Results first posted
- 2020-06-17
- Limitations and caveats
On review of the phase II data it was determined that the study did not meet continuation criteria according to Simon II stage design and would not meet criteria even with the remaining slot filled. The study was closed to further accrual.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Maximum Tolerated Dose (MTD) of Temozolomide in Combination With 400 mg Pazopanib in Patients With Advanced Pancreatic Neuroendocrine Tumor (PNET) in Phase I | After 28 days (1 cycle of treatment) | MTD and recommended phase II dose (RP2D) determination for the combination of temozolomide in combination with 400mg pazopanib in patients with advanced PNET will be achieved using a standard "3+3" dose escalation/de-escalation design. After each 3 patients are enrolled into the study, further enrollment will be temporarily suspended until safety has been reviewed for the first 28 days of treatment to determine if dose limiting toxicities have been experienced by patients and if a further 3 patients should be enrolled at the current dose or dose escalation/de-escalation for the next 3 patients should occur. |
| Primary | Overall Response Rate (ORR) in Patients With Advanced Neuroendocrine Tumors (PNET) Treated With Temozolomide and Pazopanib Combination Treatment at the RP2D in Phase II | After two cycles of treatment (8 weeks) | Overall response rate will be determined by the number of patients who's best response as assessed by RECIST 1.1 is complete response (CR) and partial response (PR) in patients with PNET that are enrolled at the recommended phase II dose (RP2D) (PK cohort included). CR= Disappearance of all target lesions PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | During treatment and up to one month post last dose of study drug. Range of cycles completed by patients was 1-41 where one cycle =28 days. | Safety and toxicity will be reported in the number of patients who experience adverse events during treatment, graded using CTCAE 4.03. In general the severity of an AE is graded as follows: Mild (grade 1): the event causes discomfort without disruption of normal daily activities. Moderate (grade 2): the event causes discomfort that affects normal daily activities. Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Life-threatening (grade 4): the patient was at risk of death at the time of the event. Fatal (grade 5): the event caused death. |
| Secondary | Plasma Temozolomide Concentration in the Blood at Various Timepoints After Administration | Multiple timepoints during Days 1-3 of cycle 1 and cycle 2 (1 cycle =28 days) | For the Six Patients in Phase I portion who are enrolled in the PK cohort: Blood will be drawn on Day 1 before beginning treatment and again at 10 minutes, 30 minutes, 1, 2, 3, 4, 6 and 8 hours after beginning treatment. On Day 2- 24 hours after the first dose from Day 1, and again 10 minutes, 30 minutes, 1, 2, 3, 4, 6 and 8 hours after taking the second dose. Day 3 - 24 hours after the second dose from Day 2. Cycle 1 Day 1 only temozolomide will be taken by the patient and on Cycle 2 Day 2, temozolomide and pazopanib will be taken by the patient. Data that was collected but not analyzed. The data that was collected is reported below in raw form. |
| Secondary | Progression Free Survival (PFS) | Baseline and after every 2 cycles of treatment (8 weeks) for up to 40 months | PFS will be defined as will be defined as the time from the first study treatment to the first occurrence of progression or death. Progressive disease will be assessed using RECIST v1.1 criteria where in general the following definition is true: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study AND an absolute increase in the sum of at least 5 mm OR the appearance of one or more new lesions |
| Secondary | Overall Survival (OS) | Baseline and after every 2 cycles of treatment (8 weeks) and up to 60 months | OS is defined as the time from first study treatment until death from any cause. |
| Secondary | Number of Patients Experiencing Response to Treatment or Stable Disease (Disease Control Rate) | After every 2 courses of treatment (8 weeks) for up to 41 cycles where 1 cycle =28 days. | Disease Control Rate (DCR) is defined as the number of patients demonstrating the complete response, partial response or stable disease. In general the following is true: Complete Response (CR) Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study |
| Secondary | Number of Months That Patients Maintain a Response to Treatment Until Disease Progression or Death (Duration of Response) | After every 2 courses of treatment (8 weeks) | Duration of response (DOR) is defined at the time from documented overall response (compete response, partial response, stable disease) until disease progression where the following are true: Complete Response (CR) Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study |
| Other | Determine the Relationship Between Tumor Blood Flow and Overall Response Rate | At Baseline and after two corurses of treatment (8 weeks) | For Patients in Phase II Portion: Patients will have a perfusion functional computed tomography (fCT) scan at baseline and after two courses of treatment. |
| Other | Amount of a Particular Tumor Biomarker in Blood as Correlated With Progression Free Survival | Baseline and at Response assessment after two courses of treatment (8 weeks) | For Patients in Phase II Portion: The level of expression of tissue methyl-guanine methytransferase (MGMT)will be measured in tissue from the diagnostic biopsy and these results will be correlated with response rate. |
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 | Determine the Maximum Tolerated Dose (MTD) of Temozolomide in Combination With 400 mg Pazopanib in Patients With Advanced Pancreatic Neuroendocrine Tumor (PNET) in Phase I | After 28 days (1 cycle of treatment) | 1 patient in Cohort -1 was not evaluable for this endpoint due to inability to absorb oral medications secondary to bowel edema | mg/m2 | NUMBER |
| PRIMARY | Overall Response Rate (ORR) in Patients With Advanced Neuroendocrine Tumors (PNET) Treated With Temozolomide and Pazopanib Combination Treatment at the RP2D in Phase II | After two cycles of treatment (8 weeks) | 1 patient was determined not to be evaluable for response in phase II | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | During treatment and up to one month post last dose of study drug. Range of cycles completed by patients was 1-41 where one cycle =28 days. | patients | NUMBER | |
| SECONDARY | Plasma Temozolomide Concentration in the Blood at Various Timepoints After Administration | Multiple timepoints during Days 1-3 of cycle 1 and cycle 2 (1 cycle =28 days) | Data that was collected but not analyzed. The data that was collected is reported below for each patient at each timepoint. | ng/mL | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline and after every 2 cycles of treatment (8 weeks) for up to 40 months | The study did not reach its anticipated sample size and anticipated endpoints for phase II. Due to this and relatively small number of patients it was determined by the PI to have no merit or statistical significance to calculate PFS per dose cohort and dose cohorts were combined to summarize PFS. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline and after every 2 cycles of treatment (8 weeks) and up to 60 months | The study did not reach its anticipated sample size and anticipated endpoints for phase II. Due to this and relatively small number of patients it was determined by the PI to have no merit or statistical significance to calculate OS per dose cohort and dose cohorts were combined to summarize OS. | months | MEDIAN |
| SECONDARY | Number of Patients Experiencing Response to Treatment or Stable Disease (Disease Control Rate) | After every 2 courses of treatment (8 weeks) for up to 41 cycles where 1 cycle =28 days. | The study did not reach its anticipated sample size and anticipated endpoints for phase II. Due to this and relatively small number of patients it was determined by the PI to have no merit or statistical significance to calculate DCR per dose cohort and dose cohorts were combined to summarize DCR. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Months That Patients Maintain a Response to Treatment Until Disease Progression or Death (Duration of Response) | After every 2 courses of treatment (8 weeks) | Data not collected or analyzed for this outcome measure | ||
| OTHER_PRE_SPECIFIED | Determine the Relationship Between Tumor Blood Flow and Overall Response Rate | At Baseline and after two corurses of treatment (8 weeks) | |||
| OTHER_PRE_SPECIFIED | Amount of a Particular Tumor Biomarker in Blood as Correlated With Progression Free Survival | Baseline and at Response assessment after two courses of treatment (8 weeks) |
Source ClinicalTrials.gov
Results by group149
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Maximum Tolerated Dose (MTD) of Temozolomide in Combination With 400 mg Pazopanib in Patients With Advanced Pancreatic Neuroendocrine Tumor (PNET) in Phase I | Cohort 1/Cohort -1/Cohort -2 - Temozolomide and Pazopanib | 75 | mg/m2 | ||
| Overall Response Rate (ORR) in Patients With Advanced Neuroendocrine Tumors (PNET) Treated With Temozolomide and Pazopanib Combination Treatment at the RP2D in Phase II | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 0 | Participants | ||
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | Any AE | 7 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | Any AE | 5 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | Any AE | 6 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | Any AE | 11 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | AE related to treatment | 7 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | AE related to treatment | 5 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | AE related to treatment | 6 | patients | |
| Number of Patients Who Experience Toxicity Events Undergoing This Treatment. | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | AE related to treatment | 11 | patients |
1 to 10 of 149Source ClinicalTrials.gov
See all 149 results by groupParticipant flow64
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed 1 Cycle of Treatment | STARTED | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 7 | |
| Completed 1 Cycle of Treatment | STARTED | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 5 | |
| Completed 1 Cycle of Treatment | STARTED | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 6 | |
| Completed 1 Cycle of Treatment | STARTED | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 11 | |
| Completed 1 Cycle of Treatment | Completed 1 Cycle of Treatment | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 7 | |
| Completed 1 Cycle of Treatment | Completed 1 Cycle of Treatment | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 4 | |
| Completed 1 Cycle of Treatment | Completed 1 Cycle of Treatment | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 6 | |
| Completed 1 Cycle of Treatment | Completed 1 Cycle of Treatment | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 11 | |
| Completed 1 Cycle of Treatment | COMPLETED | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 7 | |
| Completed 1 Cycle of Treatment | COMPLETED | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 4 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 participant flowAdverse events672
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 | Hearing impaired | Ear and labyrinth disorders | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 1 | 7 | |
| other | Hearing impaired | Ear and labyrinth disorders | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 0 | 5 | |
| other | Hearing impaired | Ear and labyrinth disorders | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 0 | 6 | |
| other | Hearing impaired | Ear and labyrinth disorders | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 1 | 17 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 6 | 7 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 4 | 5 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 3 | 6 | |
| other | Hemoglobin (anemia) | Blood and lymphatic system disorders | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 6 | 17 | |
| other | Petechiae | Blood and lymphatic system disorders | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 1 | 7 | |
| other | Petechiae | Blood and lymphatic system disorders | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 0 | 5 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 6 | 7 |
| Total, all-cause mortality | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 4 | 5 |
| Total, all-cause mortality | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 2 | 6 |
| Total, all-cause mortality | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 4 | 11 |
| Total, other adverse events | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 7 | 7 |
| Total, other adverse events | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 5 | 5 |
| Total, other adverse events | Cohort -2 - Temozolomide 75 mg/m2 and Pazopanib 400 mg | 6 | 6 |
| Total, other adverse events | Phase II -Temozolomide 75 mg/m2 and Pazopanib 400 mg | 17 | 17 |
| Total, serious adverse events | Cohort 1 - Temozolomide 150 mg/m2 and Pazopanib 400 mg | 3 | 7 |
| Total, serious adverse events | Cohort -1 -Temozolomide 100 mg/m2 and Pazopanib 400 mg | 3 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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