Trial · NCT01100931

A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)

NCT01100931, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-04-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II). Trials, record NCT01100931. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01100931

On this page

Trial

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

Title: A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)
NCT number: NCT01100931
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 42 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: NSCLC, Solid Tumors
Interventions: YM155, Carboplatin, Paclitaxel
First posted: 2010-04-09
Last updated: 2015-10-19
Results first posted: 2013-04-04

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Phase 1 Safe and Tolerable Phase 2 Dose.	1 year	Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1.
Primary	Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).	up to 18 weeks	Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Primary	Number of Participants With Adverse Events	31.5 months	Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1 Safe and Tolerable Phase 2 Dose.	1 year	Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m\^2.	mg/m^2	NUMBER
PRIMARY	Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).	up to 18 weeks	Phase I is not included here because this outcome measure is for phase II only.	Participants	NUMBER
PRIMARY	Number of Participants With Adverse Events	31.5 months		Participants	NUMBER

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Units
Phase 1 Safe and Tolerable Phase 2 Dose.	Phase I		10	mg/m^2
Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).	Phase II	Complete Response	0	Participants
Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).	Phase II	Partial Response	2	Participants
Number of Participants With Adverse Events	Phase I		22	Participants
Number of Participants With Adverse Events	Phase II		19	Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Phase I	STARTED	Phase I	22
Phase I	STARTED	Phase II	0
Phase I	COMPLETED	Phase I	22
Phase I	COMPLETED	Phase II	0
Phase I	NOT COMPLETED	Phase I	0
Phase I	NOT COMPLETED	Phase II	0
Phase II	STARTED	Phase I	0
Phase II	STARTED	Phase II	19
Phase II	COMPLETED	Phase I	0
Phase II	COMPLETED	Phase II	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events328

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	Abdominal pain	Gastrointestinal disorders	Phase I	4	22	5
other	Abdominal pain	Gastrointestinal disorders	Phase II	0	19	0
other	Activated partial thromboplastin time prolonged	Investigations	Phase I	7	22	11
other	Activated partial thromboplastin time prolonged	Investigations	Phase II	0	19	0
other	Acute kidney injury	Renal and urinary disorders	Phase I	1	22	1
other	Acute kidney injury	Renal and urinary disorders	Phase II	0	19	0
other	Agitation	Psychiatric disorders	Phase I	0	22	0
other	Agitation	Psychiatric disorders	Phase II	1	19	1
other	Alanine aminotransferase increased	Investigations	Phase I	6	22	20
other	Alanine aminotransferase increased	Investigations	Phase II	0	19	0

1 to 10 of 328Source ClinicalTrials.gov

See all 328 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I
Total, all-cause mortality	Phase II
Total, other adverse events	Phase I	22	22
Total, other adverse events	Phase II	19	19
Total, serious adverse events	Phase I	10	22
Total, serious adverse events	Phase II	1	19

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11784875	BACKGROUND	PubMed
14691125	BACKGROUND	PubMed
17237035	BACKGROUND	PubMed
23857959	DERIVED	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
Phase I vs Phase II: Number of Participants With Adverse Events	Trial comparisons
Phase I vs Phase II: 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/NCT01100931

GET https://conductscience.org/api/trials/v1/NCT01100931/events?page=2

API reference For AI assistants