Trial · NCT01830621

BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma

NCT01830621, Phase 3, Completed, NCIC Clinical Trials Group; results first posted 2019-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma. Trials, record NCT01830621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01830621

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Trial

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

Title: BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma
NCT number: NCT01830621
Status: Completed
Phases: Phase 3
Enrollment: 282 participants, actual
Lead sponsor: NCIC Clinical Trials Group
Conditions: Colorectal Carcinoma
Interventions: BBI608, Placebo, Best Supportive Care
First posted: 2013-04-12
Last updated: 2023-08-28
Results first posted: 2019-03-11

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Survival	36 month	Time from the day of randomization to death. For alive patients, overall survival was censored at the last day the patient was known alive (LKA).
Secondary	Progression Free Survival	36 months	Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Secondary	Disease Control Rate	36 months	Proportion of all randomized patients with a documented complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as \>=30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) defined as \<30% decrease but also \<20% increase in the sum of the longest diameter of target lesions without new lesions per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 for target lesion.
Secondary	Number of Patients With Adverse Events	36 months	Number of patients with at least one adverse event as assessed by NCI CTCAE Version 3.0 criteria.
Secondary	Change of Global Quality of Life at 8 Weeks From Baseline	8 weeks	Change scores from baseline at time 2 (8 weeks) from baseline for the global health status/quality of life scale scores (between 0 and 100 with higher value indicating better quality of life) as derived from responses of patients to the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire (QLQ-C30).

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	Overall Survival	36 month	All patients who were randomized to this study.	Months	MEDIAN
SECONDARY	Progression Free Survival	36 months	All patients randomized to this study	Months	MEDIAN
SECONDARY	Disease Control Rate	36 months	All patients randomized to this study	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Adverse Events	36 months	All patients who have received at least one dose of BBI608/Placebo.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change of Global Quality of Life at 8 Weeks From Baseline	8 weeks	Patients who were assessed Quality of Life at baseline and week 8 from randomization.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Overall Survival	BBI608	4.44	95% Confidence Interval 3.68 to 4.90	Months
Overall Survival	Placebo	4.76	95% Confidence Interval 4.01 to 5.32	Months
Progression Free Survival	BBI608	1.82	95% Confidence Interval 1.74 to 1.87	Months
Progression Free Survival	Placebo	1.82	95% Confidence Interval 1.74 to 1.84	Months
Disease Control Rate	BBI608	17		Participants
Disease Control Rate	Placebo	18		Participants
Number of Patients With Adverse Events	BBI608	135		Participants
Number of Patients With Adverse Events	Placebo	139		Participants
Change of Global Quality of Life at 8 Weeks From Baseline	BBI608	-10.61	Standard Deviation 23.1	units on a scale
Change of Global Quality of Life at 8 Weeks From Baseline	Placebo	-10.66	Standard Deviation 17.07	units on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	BBI608	138
Overall Study	STARTED	Placebo	144
Overall Study	COMPLETED	BBI608	138
Overall Study	COMPLETED	Placebo	144
Overall Study	NOT COMPLETED	BBI608	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events192

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	Abdominal pain	Gastrointestinal disorders	BBI608	64	136
other	Abdominal pain	Gastrointestinal disorders	Placebo	56	144
other	Bloating	Gastrointestinal disorders	BBI608	8	136
other	Bloating	Gastrointestinal disorders	Placebo	9	144
other	Constipation	Gastrointestinal disorders	BBI608	48	136
other	Constipation	Gastrointestinal disorders	Placebo	60	144
other	Diarrhea	Gastrointestinal disorders	BBI608	117	136
other	Diarrhea	Gastrointestinal disorders	Placebo	46	144
other	Dry mouth	Gastrointestinal disorders	BBI608	11	136
other	Dry mouth	Gastrointestinal disorders	Placebo	7	144

1 to 10 of 192Source ClinicalTrials.gov

See all 192 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BBI608	127	136
Total, all-cause mortality	Placebo	130	144
Total, other adverse events	BBI608	134	136
Total, other adverse events	Placebo	137	144
Total, serious adverse events	BBI608	40	136
Total, serious adverse events	Placebo	29	144

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29397354	RESULT

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 comparisons4

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

Comparison	Source
BBI608 vs Placebo: Number of Patients With Adverse Events	Trial comparisons
BBI608 vs Placebo: Disease Control Rate	Trial comparisons
BBI608 vs Placebo: deaths from any cause	Trial comparisons
BBI608 vs Placebo: 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/NCT01830621

GET https://conductscience.org/api/trials/v1/NCT01830621/events?page=2

API reference For AI assistants