Trial · NCT00576680

RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

NCT00576680, Phase 1, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2020-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors. Trials, record NCT00576680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00576680

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
NCT number: NCT00576680
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 43 participants, actual
Lead sponsor: Dana-Farber Cancer Institute
Conditions: Pancreatic Neuroendocrine Tumor
Interventions: RAD001, Temozolomide
First posted: 2007-12-19
Last updated: 2020-07-09
Results first posted: 2020-07-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rate	2 years	To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
Secondary	Progression-free Survival	2 years	To determine progression-free survival when RAD001 is given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Progression-free survival is defined as time from start of therapy until disease progression, as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or death.
Secondary	To Determine the Safety and Tolerability of This Drug Combination.	2 years	To determine the safety and tolerability of RAD001 when given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Response Rate	2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	2 years	months	MEDIAN
SECONDARY	To Determine the Safety and Tolerability of This Drug Combination.	2 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Response Rate	Temozolomide and Everolimus		16		Participants
Progression-free Survival	Temozolomide and Everolimus		15.4	95% Confidence Interval 9.4 to 20.4	months
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 Lymphopenia	19		Participants
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 thrombocytopenia	7		Participants
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 mucositis	1		Participants
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 hyperglycemia	8		Participants
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 AST Increase	4		Participants
To Determine the Safety and Tolerability of This Drug Combination.	Temozolomide and Everolimus	Grade 3 or 4 Leukocyte decrease	7		Participants

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Temozolomide and Everolimus	43
Overall Study	COMPLETED	Temozolomide and Everolimus	43
Overall Study	NOT COMPLETED	Temozolomide and Everolimus	0

Source ClinicalTrials.gov

Adverse events15

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	Temozolomide and Everolimus	33	43
other	Nausea	Gastrointestinal disorders	Temozolomide and Everolimus	33	43
other	Mucositis	Gastrointestinal disorders	Temozolomide and Everolimus	27	43
other	Hyperglycemia	Endocrine disorders	Temozolomide and Everolimus	31	43
other	Hypercholesterolemia	General disorders	Temozolomide and Everolimus	18	43
other	Lymphocytopenia	Blood and lymphatic system disorders	Temozolomide and Everolimus	22	43
serious	thrombocytopenia	Blood and lymphatic system disorders	Temozolomide and Everolimus	2	43	2
serious	neutropenia	Blood and lymphatic system disorders	Temozolomide and Everolimus	2	43	2
serious	hypocalcemia	Investigations	Temozolomide and Everolimus	1	43	1
serious	creatinine	Renal and urinary disorders	Temozolomide and Everolimus	0	43	0

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Temozolomide and Everolimus	2	43
Total, other adverse events	Temozolomide and Everolimus	43	43
Total, serious adverse events	Temozolomide and Everolimus	15	43

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00576680

GET https://conductscience.org/api/trials/v1/NCT00576680/registered

API reference For AI assistants