NCT04996004TerminatedPhase 2
A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma
A Phase I/II Study of TTI-621 in Combination With Doxorubicin in Patients With Unresectable or Metastatic High-Grade Leiomyosarcoma
Source: ClinicalTrials.gov · Last updated 11 Dec 2024
Reason given: Pfizer decided to terminate the study for administrative reasons. The termination was neither due to safety concerns nor a request from the regulatory authorities.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 2 Aug 2021
- Start date
- 22 Jun 2021
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- Pfizer
- Diseases
- Sarcoma
- NCT number
- NCT04996004
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic steroid therapy.
- History or autoimmune disease that has required systemic treatment with disease-modifying agents, corticosteroids, or immunosuppressive drugs.
- Prior organ transplantation including allogenic or autologous stem cell transplantation
- Prior treatment with anti-CD47 (Cluster of Differentiation 47) or anti-signal regulatory protein alpha (SIRPα) therapy.
Other illness
- History of acute coronary syndromes.
- History of or current Class II, III, or IV heart failure.
- Significant bleeding disorders, vasculitis or a significant bleeding episode from the GI (gastrointestinal) tract.
- History of severe hypersensitivity reactions to antibodies.
Other
- History or evidence of known CNS (central nervous system) metastases or carcinomatous meningitis.
Who the study is looking for
- Eastern Co-operative Oncology Group Performance Status Performance Status (ECOG-PS) 0 or 1.
- Histologically-confirmed high-grade soft tissue sarcoma that is metastatic or locally advanced and not amenable to curative treatment with surgery or radiation.
- In the Dose Escalation phase, indications will be limited to high-grade leiomyosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, angiosarcoma and epithelioid sarcoma
- In the Dose Expansion phase, indications will be limited to high-grade leiomyosarcoma.
- Objective evidence of disease progression unless disease is newly-diagnosed.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (expansion cohorts).
- Adequate organ and hematologic function.
- No more than 1 prior treatment regimen for advanced disease, which is limited to gemcitabine with docetaxel.
- Anthracycline-naïve.
- Patients who were treated with a prior chemotherapy regimen must have completed treatment at least three weeks before initiation of study treatment.
- All adverse events from prior treatment must be NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5 Grade ≤ 1, except alopecia and stable neuropathy, which must have resolved to Grade ≤ 2 or baseline.
- Radiotherapy, including palliative radiotherapy, completed at least two weeks prior to treatment; palliative radiation to non-target lesions while on study is allowed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan | Ann Arbor | United States | Unknown status |
| MSK Basking Ridge. | Basking Ridge | United States | Unknown status |
| University Hospitals Cleveland Medical Center* | Cleveland | United States | Unknown status |
| MSK Commack. | Commack | United States | Unknown status |
| Virginia Cancer Specialists | Fairfax | United States | Unknown status |
| Hackensack University Medical Center | Hackensack | United States | Unknown status |
| MSK Westchester. | Harrison | United States | Unknown status |
| University of Iowa Hospital and Clinics | Iowa City | United States | Unknown status |
| Mayo Clinic Florida | Jacksonville | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | United States | Unknown status |
| University of Wisconsin Clinical Science Center | Madison | United States | Unknown status |
| MSK Monmouth. | Middletown | United States | Unknown status |
| MSK Bergen. | Montvale | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center 53rd street. | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center - Main Campus | New York | United States | Unknown status |
| UPMC Hillman Cancer Center | Pittsburgh | United States | Unknown status |
| Oregon Health & Science University (OHSU) | Portland | United States | Unknown status |
| Oregon Health and Science University - Center for Health and Healing 2(CHH2) | Portland | United States | Unknown status |
| Oregon Health and Science University - Center for Health and Healing 1 (CHH1) | Portland | United States | Unknown status |
| Sarcoma Oncology Research Center | Santa Monica | United States | Unknown status |
| Moffitt Cancer Center | Tampa | United States | Unknown status |
| MSK Nassau. | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.