Trial · NCT00888134

Selumetinib in Cancers With BRAF Mutations

NCT00888134, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2016-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Selumetinib in Cancers With BRAF Mutations. Trials, record NCT00888134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00888134

On this page

Trial

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

Title: Selumetinib in Cancers With BRAF Mutations
NCT number: NCT00888134
Status: Completed
Phases: Phase 2
Enrollment: 28 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Solid Neoplasm
Interventions: Selumetinib
First posted: 2009-04-27
Last updated: 2016-01-15
Results first posted: 2016-01-15

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate in Patients With Cancers Other Than Melanoma	4 years	Percentage of participants achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans (which are done every 6 weeks).
Secondary	AKT Pathway Activity	Up to 4 years	Correlation between response to AZD6244 and mutational analysis of AKT pathway (an intracellular signaling pathway important in regulating the cell cycle)
Secondary	Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers	Up to 4 years	Percentage of participants with either colon cancer or non-small cell lung cancer achieving either complete response (disappearance of all target lesions) or partial response (at least a 30% decrease in the sum of the longest diameter of target lesions, when compared with baseline) using CT (computed tomography) scans.
Secondary	Progression-free Survival	4 months	Reported as percentage of participants alive and progression free at 4-months. Will be estimated using Kaplan-Meier survival curves. Confidence intervals will be calculated and reported.
Secondary	Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip	Up to 4 years

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	Objective Response Rate in Patients With Cancers Other Than Melanoma	4 years		percentage of participants	NUMBER
SECONDARY	AKT Pathway Activity	Up to 4 years	Samples and data were not collected for this outcome.
SECONDARY	Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers	Up to 4 years		percentage of participants	NUMBER
SECONDARY	Progression-free Survival	4 months		percentage of participants	NUMBER
SECONDARY	Sensitivity and Specificity of Detection of the BRAF V600E Mutation in CTC Using the CTC-chip	Up to 4 years	Samples and data were not collected for this outcome.

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Spread	Units
Objective Response Rate in Patients With Cancers Other Than Melanoma	Treatment (Selumetinib)	0		percentage of participants
Objective Response Rate in Patients With Non-small Cell Lung Cancers and Colon Cancers	Treatment (Selumetinib)	0		percentage of participants
Progression-free Survival	Treatment (Selumetinib)	21.4	95% Confidence Interval 8.7 to 37.8	percentage of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Treatment With Study Drug	STARTED	Treatment (Selumetinib)	28
Treatment With Study Drug	COMPLETED	Treatment (Selumetinib)	27
Treatment With Study Drug	NOT COMPLETED	Treatment (Selumetinib)	1
Follow-up	STARTED	Treatment (Selumetinib)	27
Follow-up	COMPLETED	Treatment (Selumetinib)	26
Follow-up	NOT COMPLETED	Treatment (Selumetinib)	1

Source ClinicalTrials.gov

Adverse events90

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	allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Treatment (Selumetinib)	2	28
other	tinnitus	Ear and labyrinth disorders	Treatment (Selumetinib)	2	28
other	hemoglobin - low	Blood and lymphatic system disorders	Treatment (Selumetinib)	19	28
other	leukocytes	Blood and lymphatic system disorders	Treatment (Selumetinib)	2	28
other	lymphopenia	Blood and lymphatic system disorders	Treatment (Selumetinib)	8	28
other	platelets	Blood and lymphatic system disorders	Treatment (Selumetinib)	6	28
other	hypertension	Cardiac disorders	Treatment (Selumetinib)	3	28
other	INR	Investigations	Treatment (Selumetinib)	3	28
other	PTT	Investigations	Treatment (Selumetinib)	3	28
other	fatigue	General disorders	Treatment (Selumetinib)	19	28

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment (Selumetinib)
Total, other adverse events	Treatment (Selumetinib)	28	28
Total, serious adverse events	Treatment (Selumetinib)	17	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants2

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	Source
P30CA006516	Dana-Farber/Harvard Cancer Center	EBERT, BENJAMIN LEVINE	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2025	NIH RePORTER
U01CA062490	Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis	KUFE, DONALD W.	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1994 to 2013	NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT00888134

GET https://conductscience.org/api/trials/v1/NCT00888134/events?page=2

API reference For AI assistants