Trial Outcomes & Findings for Sunitinib in Certain Subtypes of Soft Tissue Sarcomas (NCT NCT00859456)

Results Overview

CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Up to 84 days

Results posted on

2019-11-04

1 subject decided to pursue treatment elsewhere prior to receiving study drug after consent.

Participant milestones
Measure	Sunitinib Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Overall Study STARTED	9
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	8

Reasons for withdrawal
Measure	Sunitinib Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Overall Study Adverse Event	3
Overall Study Progressive disease	2
Overall Study Non-compliance	3

Sunitinib in Certain Subtypes of Soft Tissue Sarcomas

Baseline characteristics by cohort
Measure	Sunitinib n=9 Participants Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

Timeframe: Up to 84 days

CT or MRI to monitor response: CT or MRI to assess tumor measurement based on the RECIST criteria

Outcome measures
Measure	Sunitinib n=9 Participants Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Number of Subjects With Stable Disease at First Assessment of Response	6 participants

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	Sunitinib n=9 participants at risk Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Cardiac disorders Acute Myocardial Infarction	11.1% 1/9

Other adverse events
Measure	Sunitinib n=9 participants at risk Patients with unresectable or metastatic angiosarcoma, epithelioid sarcoma-like hemangioendothelioma and Kaposi's sarcoma, either receiving Sunitinib as first-line therapy or failure after no more than 2 prior chemotherapy regimens. Sunitinib: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice. A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
General disorders Fatigue	11.1% 1/9
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	22.2% 2/9
Gastrointestinal disorders Mucositis	11.1% 1/9
Gastrointestinal disorders Nausea	11.1% 1/9
Gastrointestinal disorders Vomiting	11.1% 1/9
General disorders Night sweats	11.1% 1/9
General disorders Upper Respiratory Infection	11.1% 1/9

Columbia University