Trial · NCT01228435

IPI-504 in NSCLC Patients With ALK Translocations

NCT01228435, Phase 2, Terminated, Massachusetts General Hospital; results first posted 2013-10-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. IPI-504 in NSCLC Patients With ALK Translocations. Trials, record NCT01228435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01228435

On this page

Trial

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

Title: IPI-504 in NSCLC Patients With ALK Translocations
NCT number: NCT01228435
Status: Terminated
Phases: Phase 2
Enrollment: 3 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Lung Cancer, Stage IIIb Lung Cancer, Stage IV Lung Cancer
Interventions: IPI-504
First posted: 2010-10-26
Last updated: 2017-12-04
Results first posted: 2013-10-23
Limitations and caveats: The study was unable to accrue sufficient participants due to competing studies. Therefore, the study results are not sufficiently powered to draw any conclusions.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Response Rate	2 years	The response rate was defined as the number of patients achieving a RECIST 1.0 defined response divided by the number of patients treated and was to be calculated separately for each arm. A response by RECIST criteria means that the pre-defined target lesions (sum of the longest diameters) had to decrease by 30% or more and this response needed to be confirmed on a second scan at least 4 weeks later.
Secondary	Number of Participants With Treatment-Emergent Adverse Events	2 years	Further document the safety of this regimen. Treatment-emergent adverse events will be summarized by MedDRA coding terms and separate tabulations will be produced for treatment-emergent adverse events, treatment-emergent serious adverse events, discontinuations due to adverse events, and treatment-emergent events of at least Grade 3 severity. A treatment-emergent adverse event is defined as an adverse event that was deemed to be related to the study intervention.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate	2 years		participants	NUMBER
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events	2 years		participants	NUMBER

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Units
Response Rate	ALK-inhibitor Naive		participants
Response Rate	ALK-inhibitor Pre-treated		participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Naive	Treatment-emergent adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Pre-treated	Treatment-emergent adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Naive	Treatment-emergent serious adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Pre-treated	Treatment-emergent serious adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Naive	discontinuations due to adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Pre-treated	discontinuations due to adverse events	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Naive	treatment-emergent events ≥ grade 3	participants
Number of Participants With Treatment-Emergent Adverse Events	ALK-inhibitor Pre-treated	treatment-emergent events ≥ grade 3	participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ALK-inhibitor Naive	1
Overall Study	STARTED	ALK-inhibitor Pre-treated	2
Overall Study	COMPLETED	ALK-inhibitor Naive	1
Overall Study	COMPLETED	ALK-inhibitor Pre-treated	2
Overall Study	NOT COMPLETED	ALK-inhibitor Naive	0
Overall Study	NOT COMPLETED	ALK-inhibitor Pre-treated	0

Source ClinicalTrials.gov

Adverse events8

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	Fatigue	General disorders	ALK-inhibitor Naive	1	1
other	Fatigue	General disorders	ALK-inhibitor Pre-treated	0	2
other	Arthralgias	Musculoskeletal and connective tissue disorders	ALK-inhibitor Naive	0	1
other	Arthralgias	Musculoskeletal and connective tissue disorders	ALK-inhibitor Pre-treated	1	2
other	Elevated AST	Hepatobiliary disorders	ALK-inhibitor Naive	0	1
other	Elevated AST	Hepatobiliary disorders	ALK-inhibitor Pre-treated	1	2
other	Anemia	Blood and lymphatic system disorders	ALK-inhibitor Naive	1	1
other	Anemia	Blood and lymphatic system disorders	ALK-inhibitor Pre-treated	1	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ALK-inhibitor Naive	0	1
Total, all-cause mortality	ALK-inhibitor Pre-treated	0	2
Total, other adverse events	ALK-inhibitor Naive	1	1
Total, other adverse events	ALK-inhibitor Pre-treated	2	2
Total, serious adverse events	ALK-inhibitor Naive	0	1
Total, serious adverse events	ALK-inhibitor Pre-treated	0	2

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 comparisons3

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

Comparison	Source
ALK-inhibitor Naive vs ALK-inhibitor Pre-treated: Response Rate	Trial comparisons
ALK-inhibitor Naive vs ALK-inhibitor Pre-treated: deaths from any cause	Trial comparisons
ALK-inhibitor Naive vs ALK-inhibitor Pre-treated: 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/NCT01228435

GET https://conductscience.org/api/trials/v1/NCT01228435/registered

API reference For AI assistants