Trial · NCT01171924

A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors

NCT01171924, Phase 1, Completed, Curis, Inc.; results first posted 2015-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors. Trials, record NCT01171924. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01171924

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Trial

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

Title: A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
NCT number: NCT01171924
Status: Completed
Phases: Phase 1
Enrollment: 47 participants, actual
Lead sponsor: Curis, Inc.
Conditions: Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer, Non-Small Cell Lung Cancer
Interventions: CUDC-101, CUDC-101
First posted: 2010-07-29
Last updated: 2016-03-01
Results first posted: 2015-10-16

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	12-15 months	Safety and tolerability will be assessed in the two treatment arms and the incidence of adverse events will be compared.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	12-15 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events	Arm A: 5 Days/Week Schedule		23		participants
Number of Participants With Adverse Events	Arm B: 3 Days/Week Schedule		23		participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: 5 Days/Week Schedule	23
Overall Study	STARTED	Arm B: 3 Days/Week Schedule	23
Overall Study	COMPLETED	Arm A: 5 Days/Week Schedule	0
Overall Study	COMPLETED	Arm B: 3 Days/Week Schedule	0
Overall Study	NOT COMPLETED	Arm A: 5 Days/Week Schedule	23
Overall Study	NOT COMPLETED	Arm B: 3 Days/Week Schedule	23

Source ClinicalTrials.gov

Adverse events78

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
other	Nausea	General disorders	Arm A: 5 Days/Week	3	23
other	Nausea	General disorders	Arm B: 3 Days/Week	9	23
other	Fatigue	General disorders	Arm A: 5 Days/Week	2	23
other	Fatigue	General disorders	Arm B: 3 Days/Week	7	23
other	Vomiting	Gastrointestinal disorders	Arm A: 5 Days/Week	2	23
other	Vomiting	Gastrointestinal disorders	Arm B: 3 Days/Week	6	23
other	Blood Creatinine Increased	Blood and lymphatic system disorders	Arm A: 5 Days/Week	5	23
other	Blood Creatinine Increased	Blood and lymphatic system disorders	Arm B: 3 Days/Week	2	23
other	Anaemia	Blood and lymphatic system disorders	Arm A: 5 Days/Week	4	23
other	Anaemia	Blood and lymphatic system disorders	Arm B: 3 Days/Week	2	23

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: 5 Days/Week
Total, all-cause mortality	Arm B: 3 Days/Week
Total, other adverse events	Arm A: 5 Days/Week	23	23
Total, other adverse events	Arm B: 3 Days/Week	23	23
Total, serious adverse events	Arm A: 5 Days/Week	12	23
Total, serious adverse events	Arm B: 3 Days/Week	9	23

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20388807	BACKGROUND

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: 5 Days/Week Schedule vs Arm B: 3 Days/Week Schedule: Number of Participants With Adverse Events	Trial comparisons
Arm A: 5 Days/Week vs Arm B: 3 Days/Week: serious adverse events	Trial comparisons

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/NCT01171924

GET https://conductscience.org/api/trials/v1/NCT01171924/events?page=2

API reference For AI assistants