Trial · NCT01533181

Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer

NCT01533181, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer. Trials, record NCT01533181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01533181

On this page

Trial

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

Title: Linsitinib or Topotecan Hydrochloride in Treating Patients With Relapsed Small Cell Lung Cancer
NCT number: NCT01533181
Status: Completed
Phases: Phase 2
Enrollment: 44 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Small Cell Lung Carcinoma
Interventions: Laboratory Biomarker Analysis, Linsitinib, Pharmacological Study, Topotecan Hydrochloride
First posted: 2012-02-15
Last updated: 2016-01-14
Results first posted: 2016-01-14

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Median Progression Free Survival (PFS)	Up to 6 months	PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.
Secondary	Disease Control Rate (DCR)	Up to 2 years	DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.
Secondary	Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs	1 year, 6 months	Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Secondary	Overall Survival (OS)	Up to 2 years	OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.
Other	Changes in Biomarker Expression	Baseline to up to day 1 of course 3	To be assessed by the Wilcoxon rank sum test.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Median Progression Free Survival (PFS)	Up to 6 months	All participants who received treatment	months	MEDIAN
SECONDARY	Disease Control Rate (DCR)	Up to 2 years	All evaluable participants at time of analysis	participants	NUMBER
SECONDARY	Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs	1 year, 6 months	All participants who received treatment	participants	NUMBER
SECONDARY	Overall Survival (OS)	Up to 2 years	All participants who received treatment	months	MEDIAN
OTHER_PRE_SPECIFIED	Changes in Biomarker Expression	Baseline to up to day 1 of course 3

Source ClinicalTrials.gov

Results by group56

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

Outcome	Group	Category	Value	Spread	Units
Median Progression Free Survival (PFS)	Arm A: Topotecan		3	95% Confidence Interval 1.5 to 3.6	months
Median Progression Free Survival (PFS)	Arm B: OS-906		1.2	95% Confidence Interval 1.1 to 1.4	months
Disease Control Rate (DCR)	Arm A: Topotecan	Complete Response	0		participants
Disease Control Rate (DCR)	Arm B: OS-906	Complete Response	0		participants
Disease Control Rate (DCR)	Arm A: Topotecan	Partial Response	2		participants
Disease Control Rate (DCR)	Arm B: OS-906	Partial Response	0		participants
Disease Control Rate (DCR)	Arm A: Topotecan	Stable Disease	4		participants
Disease Control Rate (DCR)	Arm B: OS-906	Stable Disease	1		participants
Disease Control Rate (DCR)	Arm A: Topotecan	Progressive Disease	6		participants
Disease Control Rate (DCR)	Arm B: OS-906	Progressive Disease	24		participants

1 to 10 of 56Source ClinicalTrials.gov

See all 56 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm A: Topotecan	15
Overall Study	STARTED	Arm B: OS-906	29
Overall Study	COMPLETED	Arm A: Topotecan	14
Overall Study	COMPLETED	Arm B: OS-906	28
Overall Study	NOT COMPLETED	Arm A: Topotecan	1
Overall Study	NOT COMPLETED	Arm B: OS-906	1

Source ClinicalTrials.gov

Adverse events356

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	Arm A: Topotocan	8	14	11
other	Fatigue	General disorders	Arm B: OS-906	16	28	18
other	Pain	General disorders	Arm A: Topotocan	3	14	3
other	Pain	General disorders	Arm B: OS-906	6	28	8
other	Chills	General disorders	Arm A: Topotocan	1	14	1
other	Chills	General disorders	Arm B: OS-906	2	28	2
other	Fever	General disorders	Arm A: Topotocan	2	14	2
other	Fever	General disorders	Arm B: OS-906	0	28	0
other	General Disorders - Other	General disorders	Arm A: Topotocan	1	14	1
other	General Disorders - Other	General disorders	Arm B: OS-906	2	28	2

1 to 10 of 356Source ClinicalTrials.gov

See all 356 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Topotocan
Total, all-cause mortality	Arm B: OS-906
Total, other adverse events	Arm A: Topotocan	12	14
Total, other adverse events	Arm B: OS-906	28	28
Total, serious adverse events	Arm A: Topotocan	7	14
Total, serious adverse events	Arm B: OS-906	18	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27694157	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
P30CA076292	Moffitt Cancer Center Support Grant	CLEVELAND, JOHN L.	H. LEE MOFFITT CANCER CTR & RES INST	NATIONAL CANCER INSTITUTE	1998 to 2025

Source NIH RePORTER

Trial comparisons1

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

Comparison
Arm A: Topotocan vs Arm B: OS-906: serious adverse events

Source 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/NCT01533181

GET https://conductscience.org/api/trials/v1/NCT01533181/results?page=2

API reference For AI assistants