Trial · NCT01709435

Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors

NCT01709435, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2023-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors. Trials, record NCT01709435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01709435

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Trial

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

Title: Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
NCT number: NCT01709435
Status: Completed
Phases: Phase 1
Enrollment: 41 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Primary Central Nervous System Neoplasm, Recurrent Thyroid Gland Carcinoma, Refractory Malignant Solid Neoplasm, Refractory Primary Central Nervous System Neoplasm, Thyroid Gland Medullary Carcinoma
Interventions: Cabozantinib S-malate, Laboratory Biomarker Analysis, Pharmacological Study
First posted: 2012-10-18
Last updated: 2023-12-22
Results first posted: 2023-12-21

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate	Up to 28 days	Maximum dose at which fewer than one-third of toxicity-evaluable patients experience a dose limiting toxicity during cycle 1 of therapy.
Primary	Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Up to 28 days	Number of toxicity-evaluable patients who experience a dose limiting toxicity during cycle 1 of therapy stratified by dose level and study part.
Primary	Clearance of Cabozantinib S-malate	Up to 24 hours	Median (min, max) clearance of cabozantinib stratified by dose level and study part post-dose in cycle 1, day 1.
Secondary	Disease Response of Cabozantinib S-malate	Up to 5 years	Number of response-evaluable patients with response (CR or PR) determined by RECIST guideline (version 1.1) including CR: disappearance of all target and non-target lesions; PR: at least 30% decrease in sum of diameters of target lesions.
Secondary	Overall Survival (OS) of Cabozantinib S-malate	Up to 5 years	Median (95% CI) time to death stratified by dose level and study part.
Secondary	Change From Baseline in VEGF-R2 Concentration	Up to 28 days	Median (Min, Max) of change for VEGF-R2 sample from baseline to the day 21 or 28 stratified by dose level and study part.
Secondary	Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184	Up to 28 days	Number of patients with tumor markers CEA and/or calcitonin 2x ULN at baseline defined as CR (normalization of CEA or calcitonin) or PR (at least 50% decrease in CEA or CTN) at least 4 weeks apart.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate	Up to 28 days	Eligible Patients	mg/m^2	NUMBER
PRIMARY	Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Up to 28 days	toxicity-evaluable patients	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Clearance of Cabozantinib S-malate	Up to 24 hours	Eligible Patients	ml/hr	MEDIAN
SECONDARY	Disease Response of Cabozantinib S-malate	Up to 5 years	response-evaluable patients	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival (OS) of Cabozantinib S-malate	Up to 5 years	Response evaluable Patients	Days	MEDIAN
SECONDARY	Change From Baseline in VEGF-R2 Concentration	Up to 28 days	Toxicity evaluable patients	pg/ml	MEDIAN
SECONDARY	Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184	Up to 28 days	Includes Medullary Thyroid Cancer (MTC) patients. The original protocol eligibility did not exclude Medullary Thyroid Cancer (MTC) patients from enrolling onto Part A . The exclusion was added with amendment 5A.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group33

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

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose of Cabozantinib S-malate	Treatment (Cabozantinib S-malate)	40		mg/m^2
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part A Dose Level 1: 30 mg/m^2	0		Participants
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part A Dose Level 2: 40 mg/m^2	0		Participants
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part A Dose Level 3: 55 mg/m^2	1		Participants
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part B Dose Level 2: 40 mg/m^2	1		Participants
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part PK Dose Level 2: 40 mg/m^2	4		Participants
Number of Evaluable Patients With Dose Limiting Toxicities of Cabozantinib	Part PK Dose Level 3: 55 mg/m^2	2		Participants
Clearance of Cabozantinib S-malate	Part A Dose Level 1: 30 mg/m^2	1641.7	Full Range 1020.4 to 2222.2	ml/hr
Clearance of Cabozantinib S-malate	Part A Dose Level 2: 40 mg/m^2	1724.1	Full Range 1120.4 to 4477.6	ml/hr
Clearance of Cabozantinib S-malate	Part A Dose Level 3: 55 mg/m^2	3013.8	Full Range 1556.4 to 4366.8	ml/hr

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Part A Dose Level 1: 30 mg/m^2	6
Overall Study	STARTED	Part A Dose Level 2: 40 mg/m^2	9
Overall Study	STARTED	Part A Dose Level 3: 55 mg/m^2	6
Overall Study	STARTED	Part B Dose Level 2: 40 mg/m^2	4
Overall Study	STARTED	Part PK Dose Level 2: 40 mg/m^2	10
Overall Study	STARTED	Part PK Dose Level 3: 55 mg/m^2	6
Overall Study	COMPLETED	Part A Dose Level 1: 30 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 2: 40 mg/m^2	0
Overall Study	COMPLETED	Part A Dose Level 3: 55 mg/m^2	0
Overall Study	COMPLETED	Part B Dose Level 2: 40 mg/m^2	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,698

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 distension	Gastrointestinal disorders	Part A Dose Level 1: 30 mg/m^2	0	6
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 2: 40 mg/m^2	2	9
other	Abdominal distension	Gastrointestinal disorders	Part A Dose Level 3: 55 mg/m^2	1	6
other	Abdominal distension	Gastrointestinal disorders	Part B Dose Level 2: 40 mg/m^2	1	4
other	Abdominal distension	Gastrointestinal disorders	Part PK Dose Level 2: 40 mg/m^2	2	10
other	Abdominal distension	Gastrointestinal disorders	Part PK Dose Level 3: 55 mg/m^2	0	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 1: 30 mg/m^2	2	6
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 2: 40 mg/m^2	5	9
other	Abdominal pain	Gastrointestinal disorders	Part A Dose Level 3: 55 mg/m^2	1	6
other	Abdominal pain	Gastrointestinal disorders	Part B Dose Level 2: 40 mg/m^2	2	4

1 to 10 of 1,698Source ClinicalTrials.gov

See all 1,698 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part A Dose Level 1: 30 mg/m^2	3	6
Total, all-cause mortality	Part A Dose Level 2: 40 mg/m^2	1	9
Total, all-cause mortality	Part A Dose Level 3: 55 mg/m^2	3	6
Total, all-cause mortality	Part B Dose Level 2: 40 mg/m^2	2	4
Total, all-cause mortality	Part PK Dose Level 2: 40 mg/m^2	7	10
Total, all-cause mortality	Part PK Dose Level 3: 55 mg/m^2	3	6
Total, other adverse events	Part A Dose Level 1: 30 mg/m^2	6	6
Total, other adverse events	Part A Dose Level 2: 40 mg/m^2	9	9
Total, other adverse events	Part A Dose Level 3: 55 mg/m^2	6	6
Total, other adverse events	Part B Dose Level 2: 40 mg/m^2	4	4

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
UM1CA097452	Pediatric Phase 1/Pilot Consortium	WEIGEL, BRENDA J.	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL CANCER INSTITUTE	2009 to 2018

Source NIH RePORTER

Trial comparisons1

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

Comparison
Part A Dose Level 1: 30 mg/m^2 vs Part B Dose Level 2: 40 mg/m^2: Biomarker Response (CEA and Calcitonin) in Patients With Medullary Thyroid Cancer Treated With XL184

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/NCT01709435

GET https://conductscience.org/api/trials/v1/NCT01709435/results?page=2

API reference For AI assistants