Stopped: Pfizer decided to terminate the study for administrative reasons. The termination was neither due to safety concerns nor a request from the regulatory authorities.
The purpose of this study is to learn about the safety and effects of the study medicine (called Ontorpacept or TTI-621) when given alone and when given in combination with doxorubicin for people with leiomyosarcoma. Leiomyosarcoma is a tumor of the smooth muscles. This study is seeking participants who have: * leiomyosarcoma that is advanced or has spread to other parts of the body (metastatic) * not received prior treatment with anthracyclines (a drug commonly used in patients with some kinds of cancer, including leiomyosarcoma) * not received more than one prior treatment for their leiomyosarcoma During the first 18 weeks of this study, participants will receive doxorubicin by IV infusion (given directly into a vein) at the study clinic every 3 weeks for a total of 6 doses. Participants will also receive Ontorpacept (TTI-621) by IV infusion at the study clinic on the same day as doxorubicin and again one week later for the first 18 weeks. After the first 18 weeks, participants will stop receiving doxorubicin but will continue receiving Ontorpacept (TTI-621) as IV infusion every 14 days at the study clinic. They will keep receiving Ontorpacept (TTI-621) until their cancer is no longer responding to treatment. We will examine the experiences of participants receiving Ontorpacept (TTI-621) in combination with doxorubicin in the first 18 weeks and then Ontorpacept (TTI-621) by itself after the doxorubicin is stopped. This will help us determine if the study medicine Ontorpacept (TTI-621) given with doxorubicin and then by itself is safe and effective. Participants will be involved in the study for approximately one year, depending on how their cancer responds to the study treatment. They will have study visits about 12 times in the first 18 weeks (when the study medicine Ontorpacept is given with doxorubicin) and then every two weeks after the doxorubicin is stopped and the study medicine Ontorpacept (TTI-621) is given by itself.
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs: Phase I
Timeframe: From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 1 (C1D1): Phase I
Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 1
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D1: Phase I
Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 1
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 1 Day 8 (C1D8): Phase I
Timeframe: Baseline, 30 minutes post dose on Day 8 of Cycle 1
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C1D8: Phase I
Timeframe: Baseline, 60 minutes post dose on Day 8 of Cycle 1
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 2 Day 1 (C2D1): Phase I
Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 2
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C2D1: Phase I
Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 2
Mean Change From Baseline in Blood Pressure at 30 Minutes Post Dose on Cycle 3 Day 1 (C3D1): Phase I
Timeframe: Baseline, 30 minutes post dose on Day 1 of Cycle 3
Mean Change From Baseline in Blood Pressure at 60 Minutes Post Dose on C3D1: Phase I
Timeframe: Baseline, 60 minutes post dose on Day 1 of Cycle 3
Mean Change From Baseline in Blood Pressure at Safety Follow up: Phase I
Timeframe: Baseline, Safety follow up (up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Mean Change From Baseline in Body Weight at C3D1: Phase I
Timeframe: Baseline, Day 1 of Cycle 3
Mean Change From Baseline in Body Weight at Cycle 5 Day 1 (C5D1): Phase I
Timeframe: Baseline, Day 1 of Cycle 5
Mean Change From Baseline in Body Weight at Cycle 7 Day 1 (C7D1): Phase I
Timeframe: Baseline, Day 1 of Cycle 7
Mean Change From Baseline in Body Weight at Safety Follow up: Phase I
Timeframe: Baseline, Safety follow up (up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Number of Participants With Overall Electrocardiogram (ECG) Abnormalities: Phase I
Timeframe: From first dose of study treatment (Day 1) up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Number of Participants With Shift in National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v)5.0 Grade <=2 at Baseline to >=3 Post-baseline in Hematology Parameters: Phase I
Timeframe: Baseline up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Number of Participants With Shift in NCI-CTCAE v5.0 Grade <=2 at Baseline to >=3 Post-baseline in Chemistry Parameters: Phase I
Timeframe: Baseline up to 30 Days post last dose of study treatment or start of new anti-cancer therapy whichever occurred soonest (maximum treatment exposure for Phase I was 74.1 weeks; maximum follow up to approx. 78.1 weeks)
Number of Participants With Dose Modifications: Phase I
Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 74.1 weeks for ontorpacept and 20.1 weeks for doxorubicin)
Number of Participants With Treatment Discontinuations: Phase I
Timeframe: During study treatment (from first dose of study treatment [Day 1] to maximum treatment exposure of 74.1 weeks for ontorpacept and 20.1 weeks for doxorubicin)
Objective Response Rate (ORR): Phase I and Phase II
Timeframe: From the start of study treatment until disease progression (maximum exposure up to 74.1 weeks for Phase I and 88 weeks for Phase II)