Trial · NCT04234568

Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors

NCT04234568, Phase 1, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors. Trials, record NCT04234568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04234568

On this page

Trial

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

Title: Testing the Addition of an Anti-cancer Drug, Triapine, to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Neuroendocrine Tumors
NCT number: NCT04234568
Status: Active not recruiting
Phases: Phase 1
Enrollment: 31 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Neuroendocrine Tumor
Interventions: Biospecimen Collection, Computed Tomography, Lutetium Lu 177 Dotatate, Magnetic Resonance Imaging, Triapine
First posted: 2020-01-21
Last updated: 2026-09-18
Results first posted: 2025-11-03

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) of Triapine and Recommended Phase 2 Dose (RP2D)	8 weeks (56 days)	The MTD and RP2D will be estimated using isotonic regression based on observed dose limiting toxicity from all patients enrolled in the phase 1 portion and expansion cohort. All patients who received study drugs will be included in the safety analysis.
Primary	Dose Limiting Toxicity (DLT)	8 weeks (56 days)	DLTs will be summarized descriptively at each dose level. Will be summarized based on Common Terminology Criteria for Adverse Events version 5.0. The maximum grade of toxicity for each adverse event category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. Will describe all serious (\>= grade 3) toxicity events on a patient-by-patient basis. Frequency and incidence tables of toxicity and adverse events will be generated in the overall patient group and by dose level depending on patient enrollment.
Secondary	Overall Response Rate (ORR)	From the start of the treatment until disease progression/recurrence, assessed up to 24 months	ORR will be estimated along with 95% exact binomial confidence interval.
Secondary	Progression Free Survival (PFS)	Time from registration to time of progressive disease as defined by Response Evaluation Criteria in Solid Tumors 1.1 criteria or death from any cause, whichever occurs first, assessed up to 24 months	Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated.
Secondary	Overall Survival	The time from date of enrollment to the date of death due to any cause, assessed up to 24 months	Will be estimated using the Kaplan-Meier curve and median estimates and confidence intervals will be calculated.
Other	Expression of Somatostatin Receptors	Up to 24 months	Will be summarized using descriptive statistics and changes from baseline versus follow-up time points will be assessed using paired test methodologies.
Other	Whole Exome Sequencing	Up to 24 months	Will be processed using the data processing and data analysis pipelines from the Biostatistics and Bioinformatics shared resource of Markey Cancer Center to identify candidate mutated genes with adjustment for false discovery rate.
Other	Pharmacokinetic (PK) Studies	Up to 24 months	PK parameters will be estimated from patients enrolled in the dose escalation portion of the phase 1 trial. PK parameters will be compared with historical controls, and exploratorily, we may correlate exposure to toxicity, and incorporate data into a population PK model.
Other	Krenning Score From the Gallium 68 Dotatate	Up to 24 months	Will be summarized by calculating the proportion of patients in each Krenning score category and exploratory assessments for association with clinical response (ORR) will be performed using Fisher's exact test. Median, interquartile range will be calculated for quantitative image measurements from gallium 68 dotatate and exploratory comparison of levels with clinical response (ORR) will be performed using two sample t-test or nonparametric analogs. Correlative endpoint analyses will be based on patients who received the recommended phase 2 dose from the dose escalation portion and expansion cohort.
Other	Change in Deoxyribonucleoside Concentrations	Baseline up to 24 months	Will be assessed by paired t-test or other methods. Deoxynucleoside plasma concentration as a predictor of clinical outcomes will explored by linear (progression free survival) and logistic regression (response).

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	Maximum Tolerated Dose (MTD) of Triapine and Recommended Phase 2 Dose (RP2D)	8 weeks (56 days)	One patient in the expansion phase was not evaluable for dose limiting toxicity or for MTD determination	milligrams	NUMBER
PRIMARY	Dose Limiting Toxicity (DLT)	8 weeks (56 days)	One patient from the expansion phase was not evaluable for DLTs.	participants	NUMBER
SECONDARY	Overall Response Rate (ORR)	From the start of the treatment until disease progression/recurrence, assessed up to 24 months	One patient from the escalation phase dose level 3, and two patients from the expansion phase dose level 2 were unevaluable for overall response.	percentage of participants	NUMBER
SECONDARY	Progression Free Survival (PFS)	Time from registration to time of progressive disease as defined by Response Evaluation Criteria in Solid Tumors 1.1 criteria or death from any cause, whichever occurs first, assessed up to 24 months
SECONDARY	Overall Survival	The time from date of enrollment to the date of death due to any cause, assessed up to 24 months
OTHER_PRE_SPECIFIED	Expression of Somatostatin Receptors	Up to 24 months
OTHER_PRE_SPECIFIED	Whole Exome Sequencing	Up to 24 months
OTHER_PRE_SPECIFIED	Pharmacokinetic (PK) Studies	Up to 24 months
OTHER_PRE_SPECIFIED	Krenning Score From the Gallium 68 Dotatate	Up to 24 months
OTHER_PRE_SPECIFIED	Change in Deoxyribonucleoside Concentrations	Baseline up to 24 months

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Units
Maximum Tolerated Dose (MTD) of Triapine and Recommended Phase 2 Dose (RP2D)	Escalation Phase		150	milligrams
Maximum Tolerated Dose (MTD) of Triapine and Recommended Phase 2 Dose (RP2D)	Expansion Phase		150	milligrams
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 1 (100mg Triapine)	Grade 4 Neutropenia	0	participants
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 2 (150mg Triapine)	Grade 4 Neutropenia	2	participants
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 3 (200mg Triapine)	Grade 4 Neutropenia	0	participants
Dose Limiting Toxicity (DLT)	Expansion Phase Dose Level 1 (100mg Triapine)	Grade 4 Neutropenia	0	participants
Dose Limiting Toxicity (DLT)	Expansion Phase Dose Level 2 (150mg Triapine)	Grade 4 Neutropenia	5	participants
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 1 (100mg Triapine)	Grade 5 Cardiac Arrest	0	participants
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 2 (150mg Triapine)	Grade 5 Cardiac Arrest	0	participants
Dose Limiting Toxicity (DLT)	Escalation Phase Dose Level 3 (200mg Triapine)	Grade 5 Cardiac Arrest	1	participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Escalation Phase Dose Level 1 (100mg Triapine)	3
Overall Study	STARTED	Escalation Phase Dose Level 2 (150mg Triapine)	11
Overall Study	STARTED	Escalation Phase Dose Level 3 (200mg Triapine)	1
Overall Study	STARTED	Expansion Phase Dose Level 1 (100mg Triapine)	2
Overall Study	STARTED	Expansion Phase Dose Level 2 (150mg Triapine)	14
Overall Study	COMPLETED	Escalation Phase Dose Level 1 (100mg Triapine)	3
Overall Study	COMPLETED	Escalation Phase Dose Level 2 (150mg Triapine)	11
Overall Study	COMPLETED	Escalation Phase Dose Level 3 (200mg Triapine)	1
Overall Study	COMPLETED	Expansion Phase Dose Level 1 (100mg Triapine)	2
Overall Study	COMPLETED	Expansion Phase Dose Level 2 (150mg Triapine)	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events675

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	Escalation Phase Dose Level 1 (100mg Triapine)	3	3	17
other	Anemia	Blood and lymphatic system disorders	Escalation Phase Dose Level 2 (150mg Triapine)	10	11	51
other	Anemia	Blood and lymphatic system disorders	Escalation Phase Dose Level 3 (200mg Triapine)	0	1	0
other	Anemia	Blood and lymphatic system disorders	Expansion Phase Dose Level 1 (100mg Triapine)	2	2	20
other	Anemia	Blood and lymphatic system disorders	Expansion Phase Dose Level 2 (150mg Triapine)	12	14	47
other	Methemoglobinemia	Blood and lymphatic system disorders	Escalation Phase Dose Level 1 (100mg Triapine)	0	3	0
other	Methemoglobinemia	Blood and lymphatic system disorders	Escalation Phase Dose Level 2 (150mg Triapine)	3	11	16
other	Methemoglobinemia	Blood and lymphatic system disorders	Escalation Phase Dose Level 3 (200mg Triapine)	0	1	0
other	Methemoglobinemia	Blood and lymphatic system disorders	Expansion Phase Dose Level 1 (100mg Triapine)	0	2	0
other	Methemoglobinemia	Blood and lymphatic system disorders	Expansion Phase Dose Level 2 (150mg Triapine)	0	14	0

1 to 10 of 675Source ClinicalTrials.gov

See all 675 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Escalation Phase Dose Level 1 (100mg Triapine)	0	3
Total, all-cause mortality	Escalation Phase Dose Level 2 (150mg Triapine)	2	11
Total, all-cause mortality	Escalation Phase Dose Level 3 (200mg Triapine)	0	1
Total, all-cause mortality	Expansion Phase Dose Level 1 (100mg Triapine)	0	2
Total, all-cause mortality	Expansion Phase Dose Level 2 (150mg Triapine)	2	14
Total, other adverse events	Escalation Phase Dose Level 1 (100mg Triapine)	3	3
Total, other adverse events	Escalation Phase Dose Level 2 (150mg Triapine)	11	11
Total, other adverse events	Escalation Phase Dose Level 3 (200mg Triapine)	1	1
Total, other adverse events	Expansion Phase Dose Level 1 (100mg Triapine)	2	2
Total, other adverse events	Expansion Phase Dose Level 2 (150mg Triapine)	14	14

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42518206	DERIVED

Source PubMed

Grants1

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
UM1CA186712	The Ohio State University as a Lead Academic Organization (LAO) for the Experimental Therapeutics Clinical Trials Network	CARSON, WILLIAM E.; ARNOLD, SUSANNE M; EPPERLA, NARENDRANATH	OHIO STATE UNIVERSITY	NATIONAL CANCER INSTITUTE	2014 to 2025

Source 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.

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