Trial Outcomes & Findings for Sitravatinib in Advanced Liposarcoma and Other Soft Tissue Sarcomas (NCT NCT02978859)

NCT ID: NCT02978859

Last Updated: 2024-07-18

Results Overview

The number of patients alive and without evidence of disease progression per RECIST criteria v1.1 at the 12-week scan after starting treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-07-18

Participant Flow

Participant milestones

Measure	MGCD516 Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sitravatinib in Advanced Liposarcoma and Other Soft Tissue Sarcomas

Baseline characteristics by cohort

Measure	MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants
DDLPS	27 Participants n=5 Participants
WDLPS	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

The number of patients alive and without evidence of disease progression per RECIST criteria v1.1 at the 12-week scan after starting treatment.

Outcome measures

Measure

MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.

Number of Participants Who Were Progression Free

12 Participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure

MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.

Number of Participants Who Experienced a Treatment-related Adverse Event

25 Participants

SECONDARY outcome

Timeframe: Up to 33 months

The ORR was defined as the number of patients having a best objective tumor status of complete or partial response per RECIST v1.1 criteria lasting at least 4 weeks divided by the number of evaluable patients.

Outcome measures

Measure

MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.

Overall Response Rate (ORR) of MGCD516

0 participants

SECONDARY outcome

Timeframe: Up to 33 months

PFS was defined from the date of enrollment to the date of progression or death, the last progression-free scan for patients who withdrew consent or had unexpected adverse events, or the last follow-up for patients who withdrew consent prior to the first scan, whichever occurred first.

PFS and OS were estimated using the Kaplan-Meier method.

Outcome measures

Measure

MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.

Progression Free Survival (PFS)

11.7 weeks Interval 5.9 to 35.9

SECONDARY outcome

Timeframe: Up to 33 months

OS was defined from the date of enrollment to the date of death or last follow-up, whichever occurred first.

PFS and OS were estimated using the Kaplan-Meier method.

Outcome measures

Measure

MGCD516 n=29 Participants Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.

Overall Survival (OS)

31.7 weeks Interval 18.1 to 90.1

Adverse Events

MGCD516

Serious events: 12 serious events

Other events: 17 other events

Deaths: 21 deaths

Serious adverse events

Measure	MGCD516 n=29 participants at risk Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
General disorders Hypertension (Grade 3 and 4)	24.1% 7/29 • Up to 33 months
General disorders Fatigue (Grade 3)	6.9% 2/29 • Up to 33 months
General disorders Oral mucositis (Grade 3)	3.4% 1/29 • Up to 33 months
Vascular disorders Anemia (Grade 3)	3.4% 1/29 • Up to 33 months
General disorders Weight loss (Grade 3)	3.4% 1/29 • Up to 33 months

Other adverse events

Measure	MGCD516 n=29 participants at risk Patients with locally advanced and unresectable or metastatic sarcoma will receive MGCD516 at the discretion of the principal investigator until disease progression, unacceptable toxicity or adverse event(s) or withdrawal of consent. MGCD516: Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
Gastrointestinal disorders Diarrhea	58.6% 17/29 • Up to 33 months
General disorders Hypertension (Grades 1 and 2)	27.6% 8/29 • Up to 33 months
General disorders Fatigue	37.9% 11/29 • Up to 33 months
General disorders Hoarseness	41.4% 12/29 • Up to 33 months
General disorders Oral mucositis (Grades 1 and 2)	27.6% 8/29 • Up to 33 months
General disorders Nausea	31.0% 9/29 • Up to 33 months
General disorders Anorexia	24.1% 7/29 • Up to 33 months
Gastrointestinal disorders Constipation	24.1% 7/29 • Up to 33 months
Gastrointestinal disorders Vomiting	24.1% 7/29 • Up to 33 months
General disorders Anemia (Grade 1 and 2)	13.8% 4/29 • Up to 33 months
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	17.2% 5/29 • Up to 33 months
General disorders Headache	13.8% 4/29 • Up to 33 months
General disorders Weight loss (Grade 1 and 2)	13.8% 4/29 • Up to 33 months

Additional Information

Benjamin Izar

Columbia University

Phone: 212 304 5871

Email: bi2175@cumc.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place