Trial · NCT01841736

Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

NCT01841736, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2020-06-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors. Trials, record NCT01841736. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01841736

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Trial

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

Title: Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
NCT number: NCT01841736
Status: Active not recruiting
Phases: Phase 2
Enrollment: 171 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Foregut Neuroendocrine Tumor, Hindgut Neuroendocrine Tumor, Metastatic Digestive System Neuroendocrine Tumor G1, Metastatic Neuroendocrine Tumor, Midgut Neuroendocrine Tumor G1, Neuroendocrine Tumor G2, Recurrent Digestive System Neuroendocrine Tumor G1, Regional Digestive System Neuroendocrine Tumor G1
Interventions: Biospecimen Collection, Computed Tomography, Echocardiography Test, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Multigated Acquisition Scan, Pazopanib Hydrochloride, Placebo Administration, Quality-of-Life Assessment, X-Ray Imaging
First posted: 2013-04-26
Last updated: 2026-10-06
Results first posted: 2020-06-01

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS)	From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years	PFS will be measured from date of patient entry until documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Secondary	Best Response	Up to 5 years	The best response per RECIST 1.1 criteria of participants receiving randomized treatment assignment. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites, Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study. Progressive disease (PD): Any new lesion or increase by ≥20% of previously involved sites from nadir. Note that those considered evaluable for best response here were those who had disease measurements while on treatment. Those who discontinued therapy early prior to a disease evaluation were not included.
Secondary	Overall Survival	From randomization until death from any cause, assessed up to 5 years	Overall survival (OS) will be measured from randomization until death from any cause. A patient who is alive at the time of the statistical analysis will be considered censored at the last date of known contact. OS will be estimated by the Kaplan-Meier method within each treatment arm.
Secondary	Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response	From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 years	Duration of response is defined as the time from documented response to time of progression and/or death. This time-to-event outcome will be summarized descriptively using the methods of Kaplan and Meier to characterize the cohort and distribution of this outcome.
Secondary	Time to Treatment Failure	From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years	Time to treatment failure is defined as the time from randomization to the time that treatment is terminated, including the reasons of disease progression, adverse events, withdrawal from study, or death. This time-to-event outcome will be evaluated using the methods of Kaplan and Meier.
Other	Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy	Up to 5 years	Time to second progression will be defined as the progression free survival from crossover re-registration to documented progression of disease as determined by central review or death from any cause. If a patient does not have a documented date of progression or death, then PFS will be censored at the date of last adequate assessment. PFS will be estimated within treatment arm using the Kaplan-Meier method. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.
Other	PFS Within Each Arm	At 6 months	Kaplan-Meier methods will be used including calculations of 95% confidence intervals.
Other	Biochemical Response	Up to 5 years	Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline, and for 5-hydroxyindoleacetic acid \[5-HIAA\], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of serum chromogranin A (CGA) and 5-HIAA.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS)	From date of patient entry until documented progression of disease or death from any cause, assessed up to 5 years		months	MEDIAN
SECONDARY	Best Response	Up to 5 years	Per protocol, patients who crossover from placebo to active therapy at the time of progression will be followed for a second progression unless they withdraw from treatment for other reasons; in that case they will be followed for toxicity and survival only; thus response data are not available for Placebo Crossover group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	From randomization until death from any cause, assessed up to 5 years	This trial only has two arms ((Arm I (pazopanib hydrochloride) and Arm II (placebo)) that were analyzed. Pazopanib hydrochloride and Pazopanib are synonyms and Pazopanib was deleted. Per protocol, OS will be estimated by the Kaplan-Meier method within each treatment arm. OS for placebo patients who crossed over is not a specified outcome measure.	months	MEDIAN
SECONDARY	Duration of Response for the Subset of Patients With a Confirmed Complete Response or Partial Response	From first documented evidence of complete response or partial response until first documented disease progression or death from any cause, assessed up to 5 years	Duration of Response won't be a viable analysis as there aren't enough patients with partial responses	months	MEDIAN
SECONDARY	Time to Treatment Failure	From randomization until termination of protocol therapy for any reason including progression of disease, adverse events, and death, assessed up to 5 years		months	MEDIAN
OTHER_PRE_SPECIFIED	Time to Second Progression for Patients Who Crossover From Placebo to Active Therapy	Up to 5 years		months	MEDIAN
OTHER_PRE_SPECIFIED	PFS Within Each Arm	At 6 months
OTHER_PRE_SPECIFIED	Biochemical Response	Up to 5 years

Source ClinicalTrials.gov

Results by group17

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

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS)	Arm I (Pazopanib Hydrochloride)		11.6	80% Confidence Interval 11.0 to 13.0	months
Progression-free Survival (PFS)	Arm II (Placebo)		8.5	80% Confidence Interval 5.8 to 8.9	months
Best Response	Arm I (Pazopanib Hydrochloride)	Partial Response	2		Participants
Best Response	Arm II (Placebo)	Partial Response	0		Participants
Best Response	Arm I (Pazopanib Hydrochloride)	Stable Disease	70		Participants
Best Response	Arm II (Placebo)	Stable Disease	54		Participants
Best Response	Arm I (Pazopanib Hydrochloride)	Progressive Disease	4		Participants
Best Response	Arm II (Placebo)	Progressive Disease	14		Participants
Best Response	Arm I (Pazopanib Hydrochloride)	Not Evaluable	21		Participants
Best Response	Arm II (Placebo)	Not Evaluable	6		Participants

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Pazopanib Hydrochloride)	97
Overall Study	STARTED	Arm II (Placebo)	74
Overall Study	Crossover	Arm I (Pazopanib Hydrochloride)	0
Overall Study	Crossover	Arm II (Placebo)	49
Overall Study	COMPLETED	Arm I (Pazopanib Hydrochloride)	97
Overall Study	COMPLETED	Arm II (Placebo)	74
Overall Study	NOT COMPLETED	Arm I (Pazopanib Hydrochloride)	0
Overall Study	NOT COMPLETED	Arm II (Placebo)	0

Source ClinicalTrials.gov

Adverse events729

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	Anemia	Blood and lymphatic system disorders	Arm I (Pazopanib Hydrochloride)	17	97	67
other	Anemia	Blood and lymphatic system disorders	Arm II (Placebo)	13	74	90
other	Anemia	Blood and lymphatic system disorders	Placebo Crossover	12	49	28
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm I (Pazopanib Hydrochloride)	1	97	1
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm II (Placebo)	2	74	7
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Placebo Crossover	0	49	0
other	Leukocytosis	Blood and lymphatic system disorders	Arm I (Pazopanib Hydrochloride)	1	97	1
other	Leukocytosis	Blood and lymphatic system disorders	Arm II (Placebo)	1	74	1
other	Leukocytosis	Blood and lymphatic system disorders	Placebo Crossover	0	49	0
other	Atrial fibrillation	Cardiac disorders	Arm I (Pazopanib Hydrochloride)	0	97	0

1 to 10 of 729Source ClinicalTrials.gov

See all 729 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Pazopanib Hydrochloride)	49	97
Total, all-cause mortality	Arm II (Placebo)	40	74
Total, all-cause mortality	Placebo Crossover	29	49
Total, other adverse events	Arm I (Pazopanib Hydrochloride)	90	97
Total, other adverse events	Arm II (Placebo)	71	74
Total, other adverse events	Placebo Crossover	49	49
Total, serious adverse events	Arm I (Pazopanib Hydrochloride)	16	97
Total, serious adverse events	Arm II (Placebo)	3	74
Total, serious adverse events	Placebo Crossover	2	49

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40902132	DERIVED

Source PubMed

Grants3

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA180830	NCI NCTN- Network Lead Academic Participating Site: USC	LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN	UNIVERSITY OF SOUTHERN CALIFORNIA	NATIONAL CANCER INSTITUTE	2014 to 2018	NIH RePORTER
U10CA031946	Cancer and Leukemia Group B	BERTAGNOLLI, MONICA M	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

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/NCT01841736

GET https://conductscience.org/api/trials/v1/NCT01841736/events?page=2

API reference For AI assistants