Trial · NCT01208051

Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer

NCT01208051, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-07-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer. Trials, record NCT01208051. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208051

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Trial

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

Title: Cediranib Maleate With or Without Lenalidomide for the Treatment of Thyroid Cancer
NCT number: NCT01208051
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 127 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Refractory Differentiated Thyroid Gland Carcinoma, Refractory Thyroid Gland Follicular Carcinoma, Refractory Thyroid Gland Hurthle Cell Carcinoma, Refractory Thyroid Gland Papillary Carcinoma, Unresectable Thyroid Gland Carcinoma
Interventions: Cediranib, Cediranib Maleate, Laboratory Biomarker Analysis, Lenalidomide
First posted: 2010-09-23
Last updated: 2021-07-15
Results first posted: 2021-07-15

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Dose Limiting Toxicity	28 days	Dose limiting toxicity was defined as any of the following occurring during the first cycle (28 days) of therapy: Hematological toxicities: * Any grade 4 neutropenia (ANC \< 500) lasting more than 5 days * Any grade 4 neutropenia with concomitant fever (temperature \> 38.5) * Any grade 4 neutropenia and sepsis or other severe infection * Any grade 4 thrombocytopenia Any other grade 3-4 non-hematological adverse drug reactions, except untreated nausea/vomiting, or hypersensitivity reactions. Grade 4 hypertension Grade 4 proteinuria Delay in the administration of a subsequent dose of cediranib and lenalidomide exceeding 2 weeks, due to an adverse drug reaction
Primary	Progression-free Survival (Phase II Futility Analysis)	Assessed up to 3 years	Time from enrollment on study to disease progression or death from any cause. Surviving patients without progression are censored as of the date of the last negative examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This analysis corresponds to the planned futility analysis after 40 events.
Primary	Progression-free Survival (Final Results After Crossover)	Assessed up to 3 years	Time from study enrollment until disease progression or death from any cause. Surviving patients without progression are censored as of the date of the last negative examination. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Secondary	Objective Response Rate	Assessed up to 3 years	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Overall Survival (Final Results After Crossover)	24 months	Time from randomization to death from any cause. Patients who have not died are censored as of the date last known alive.
Secondary	Percent Change in Tumor Size (Phase II)	From baseline to 2 months	The percent change in tumor size from baseline to the end of cycle 2 (two months). The post-treatment total sum of lengths for a patient with a new lesion at cycle 2 will be scored as 1.2\*max(pre-sum, post-sum) to ensure that the appearance of new lesions corresponds to a disease progression per Response Evaluation Criteria in Solid Tumors criteria. In the event of any early deaths prior to cycle 2, a nonparametric rank sum test will be used with deaths ranked at the extreme end of the distribution.
Secondary	Serial Measurements of Thyroid Stimulating Hormone and Thyroglobulin	Up to 3 years	Thyroid stimulating hormone and thyroglobulin levels
Secondary	Presence or Absence of B-RAF and RAS Mutations and Outcomes	Up to 3 years	Presence or absence of B-RAF and RAS mutations at baseline--to be correlated with response rates, progression-free survival, and overall survival.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Dose Limiting Toxicity	28 days	Dose limiting toxicity was no an endpoint for the phase II study.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Progression-free Survival (Phase II Futility Analysis)	Assessed up to 3 years	Phase I study did not have a futility analysis. For phase II, one patient in Arm B was enrolled while the futility analysis was ongoing.	months	MEDIAN
PRIMARY	Progression-free Survival (Final Results After Crossover)	Assessed up to 3 years		months	MEDIAN
SECONDARY	Objective Response Rate	Assessed up to 3 years		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival (Final Results After Crossover)	24 months		percentage of participants	NUMBER
SECONDARY	Percent Change in Tumor Size (Phase II)	From baseline to 2 months	Percent change in tumor size was not an endpoint for the phase I study.	percent change	MEDIAN
SECONDARY	Serial Measurements of Thyroid Stimulating Hormone and Thyroglobulin	Up to 3 years	These outcomes were not assessed in the Phase I study. These data were not collected and analyzed for the phase II study because combination treatment was stopped due to reaching futility criteria at interim analysis.
SECONDARY	Presence or Absence of B-RAF and RAS Mutations and Outcomes	Up to 3 years	Mutations were not endpoints for the phase I study. These data were not collected and analyzed in the phase II study because combination treatment was stopped due to reaching futility criteria at interim analysis.

Source ClinicalTrials.gov

Results by group22

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

Outcome	Group	Value	Spread	Units
Dose Limiting Toxicity	Phase I Dose Level 0	0		Participants
Dose Limiting Toxicity	Phase I Dose Level +1	1		Participants
Dose Limiting Toxicity	Phase I Dose Level +2	2		Participants
Progression-free Survival (Phase II Futility Analysis)	Phase II Arm A (Cediranib Maleate)	20.9	95% Confidence Interval 10.9 to NA	months
Progression-free Survival (Phase II Futility Analysis)	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	10.6	95% Confidence Interval 7.3 to 14.6	months
Progression-free Survival (Final Results After Crossover)	Dose Level 0	NA	95% Confidence Interval NA to NA	months
Progression-free Survival (Final Results After Crossover)	Dose Level +1	14.8	95% Confidence Interval 3.5 to 30.9	months
Progression-free Survival (Final Results After Crossover)	Dose Level +2	23.6	95% Confidence Interval 2.5 to 49.5	months
Progression-free Survival (Final Results After Crossover)	Phase II Arm A (Cediranib Maleate)	14.8	95% Confidence Interval 8.5 to 23.8	months
Progression-free Survival (Final Results After Crossover)	Phase II Arm B (Cediranib Maleate Plus Lenalidomide)	11.3	95% Confidence Interval 8.7 to 18.9	months

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow45

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

Period	Milestone	Group	Participants
Total Enrollment	STARTED	Phase I Dose Level 0	4
Total Enrollment	STARTED	Phase I Dose Level +1	7
Total Enrollment	STARTED	Phase I Dose Level +2	6
Total Enrollment	STARTED	Phase II Arm A (Cediranib Maleate)	39
Total Enrollment	STARTED	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	71
Total Enrollment	COMPLETED	Phase I Dose Level 0	4
Total Enrollment	COMPLETED	Phase I Dose Level +1	6
Total Enrollment	COMPLETED	Phase I Dose Level +2	5
Total Enrollment	COMPLETED	Phase II Arm A (Cediranib Maleate)	39
Total Enrollment	COMPLETED	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	69

1 to 10 of 45Source ClinicalTrials.gov

See all 45 participant flow

Adverse events915

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	Phase I Dose Level 0	1	4
other	Abdominal pain	Gastrointestinal disorders	Phase I Dose Level +1	1	6
other	Abdominal pain	Gastrointestinal disorders	Phase I Dose Level +2	0	5
other	Abdominal pain	Gastrointestinal disorders	Phase II Arm A (Cediranib Maleate)	6	39
other	Abdominal pain	Gastrointestinal disorders	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	10	69
other	Alanine aminotransferase increased	Investigations	Phase I Dose Level 0	2	4
other	Alanine aminotransferase increased	Investigations	Phase I Dose Level +1	5	6
other	Alanine aminotransferase increased	Investigations	Phase I Dose Level +2	3	5
other	Alanine aminotransferase increased	Investigations	Phase II Arm A (Cediranib Maleate)	12	39
other	Alanine aminotransferase increased	Investigations	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	31	69

1 to 10 of 915Source ClinicalTrials.gov

See all 915 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I Dose Level 0	0	4
Total, all-cause mortality	Phase I Dose Level +1	0	6
Total, all-cause mortality	Phase I Dose Level +2	0	5
Total, all-cause mortality	Phase II Arm A (Cediranib Maleate)	8	39
Total, all-cause mortality	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	13	69
Total, other adverse events	Phase I Dose Level 0	4	4
Total, other adverse events	Phase I Dose Level +1	6	6
Total, other adverse events	Phase I Dose Level +2	5	5
Total, other adverse events	Phase II Arm A (Cediranib Maleate)	38	39
Total, other adverse events	Phase II Arm B (Cediranib Maleate Plus Lenalidomide Thru April 10, 2015)	66	69

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

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
U10CA180821	Alliance for Clinical Trials in Oncology Operations Center	Galanis, Evanthia; Hahn, Olwen; Kozono, David	ALLIANCE NCTN FOUNDATION	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
P30CA014599	Cancer Center Support Grant	ODUNSI, KUNLE	UNIVERSITY OF CHICAGO	NATIONAL CANCER INSTITUTE	1985 to 2025	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/NCT01208051

GET https://conductscience.org/api/trials/v1/NCT01208051/results?page=2

API reference For AI assistants