Study Summary
This trial is testing a new drug, TTI-621, for patients with leiomyosarcoma that cannot be removed by surgery or has spread to other parts of the body.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
20 Primary · 23 Secondary · Reporting Duration: Through completion of Phase II, months 6 to 32
Day 30
Number of participants by causality of adverse events (AEs) by dose level
Number of participants by frequency of adverse events (AEs) by dose level
Number of participants by severity of adverse events (AEs) by dose level
Number of participants by timing of adverse events (AEs) by dose level
Number of participants by type of adverse events (AEs) by dose level
Phase II: Number of participants by causality of adverse events (AEs) by dose level
Phase II: Number of participants by frequency of adverse events (AEs) by dose level
Phase II: Number of participants by severity of adverse events (AEs) by dose level
Phase II: Number of participants by timing of adverse events (AEs) by dose level
Phase II: Number of participants by type of adverse events (AEs) by dose level
Day 30
Number of participants with abnormal ECGs (electrocardiograms)
Number of participants with abnormal laboratory results
Number of participants with abnormal vital signs
Number of participants with treatment delays or discontinuations
Phase II: Number of participants with abnormal ECGs (electrocardiograms)
Phase II: Number of participants with abnormal laboratory results
Phase II: Number of participants with abnormal vital signs
Phase II: Number of participants with treatment delays or discontinuations
Month 32
Percentage of patients with objective response
Phase II: Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Phase II: Change in ECOG (Eastern Cooperative Oncology Group) Performance status
Phase II: Disease control rate (DCR)
Phase II: Duration of disease control
Phase II: Duration of response
Phase II: Progression-free survival (PFS)
Phase II: Time to development of new metastases
Phase II: Time to disease progression
From initiation of treatment until death
Phase II: Overall survival
Month 6
Phase I: Characterize the safety of escalating dose levels of TTI-621 in combination with doxorubicin: causal relationship of adverse events
Phase I: Characterize the safety of escalating dose levels of TTI-621 in combination with doxorubicin: frequency of adverse events
Phase I: Characterize the safety of escalating dose levels of TTI-621 in combination with doxorubicin: severity of adverse events
Phase I: Characterize the safety of escalating dose levels of TTI-621 in combination with doxorubicin: timing of adverse events
Phase I: Characterize the safety of escalating dose levels of TTI-621 in combination with doxorubicin: type of adverse events
Month 6
Phase II: Characterize antitumor activity of TTI-621: disease control rate
Phase II: Characterize antitumor activity of TTI-621: duration of response
Phase II: Characterize antitumor activity of TTI-621: overall survival
Phase II: Characterize antitumor activity of TTI-621: progression-free survival
Phase II: Characterize antitumor activity of TTI-621: time to progression
Phase II: Characterize the safety of selected dose levels of TTI-621 in combination with doxorubicin: causal relationship of adverse events
Doxorubicin
Phase II: Characterize the safety of selected dose levels of TTI-621 in combination with doxorubicin: severity of adverse events
Doxorubicin
Phase II: Percentage of Patients with Objective Response
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Saline
47%Anemia
41%Nausea
31%Lymphocyte count decreased
28%Fatigue
28%Neutrophil count decreased
28%White blood cell decreased
13%Constipation
13%Headache
13%Hypoatremia
13%Platelet count decreased
13%Paresthesia
9%Cough
9%Hypocalcemia
9%Alanine aminotransferase increased
9%Myalgia
9%Hypokalemia
9%Vomiting
9%Hypoalbuminemia
6%Chills
6%Dyspnea
6%Edema Limbs
6%Flank Pain
6%Febrile neutropenia
6%Mucositis oral
6%Hypernatremia
6%Insomnia
6%Pain
3%Vaginal Infection
3%Palpitations
3%Wheezing
3%Blurred Vision
3%MRSA positive infection in toe
3%Alkaline phosphatase increased
3%Blood bilirubin increased
3%Allergic rhinitis
3%Anorexia
3%Lung Infection
3%Depression
3%Arthralgia
3%Dermatitis
3%Creatinine increased
3%Diarrhea
3%Gastritis
3%Esophageal Spasms
3%Hemorrhoids
3%Hypomagnesemia
3%Fibrinogen decreased
3%Hyperglycemia
3%Non-cardiac chest pain
3%Lip Infection
3%Hypotension
3%Muscle weakness upper limb
3%Pruritus
3%Sore Throat
3%Rash maculo-papular
3%Pain in extremity
3%Urinary Frequency
Trial Design
6 Treatment Groups
Dose Expansion Dose Level A (Cohort A)
1 of 6
Dose Escalation (TTI-621+doxorubicin)
1 of 6
Dose Expansion Dose Level B (Cohort B)
1 of 6
Dose Escalation
1 of 6
Dose Expansion High Dose (Cohort B)
1 of 6
Dose Expansion Low Dose (Cohort A)
1 of 6
Experimental Treatment
80 Total Participants · 6 Treatment Groups
Primary Treatment: TTI-621 · No Placebo Group · Phase 2
Dose Expansion Dose Level A (Cohort A)Experimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Dose Escalation (TTI-621+doxorubicin)Experimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Dose Expansion Dose Level B (Cohort B)Experimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Dose EscalationExperimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Dose Expansion High Dose (Cohort B)Experimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Dose Expansion Low Dose (Cohort A)Experimental Group · 2 Interventions: TTI-621, Doxorubicin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of phase ii, months 6 to 32
Who is running the clinical trial?
PfizerLead Sponsor
4,304 Previous Clinical Trials
7,094,699 Total Patients Enrolled
1 Trials studying Leiomyosarcoma
48 Patients Enrolled for Leiomyosarcoma
Trillium Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
892 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,804,590 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The Dose Expansion phase will only include patients with high-grade leiomyosarcoma.
Patients who have completed a prior chemotherapy regimen must wait at least three weeks before beginning treatment on the study.
The study evaluated the efficacy and safety of osimertinib in patients with measurable disease per RECIST v1.1 who had not received previous treatment with an EGFR inhibitor.
The patient has adequate organ function and blood cell count.
This means that the person can only receive one other treatment other than the gemcitabine and docetaxel combination.
The Eastern Cooperative Oncology Group (ECOG) defines a performance status of 0 or 1 as "fully active, able to carry out all usual activities.
A soft tissue sarcoma that is metastatic or locally advanced and not able to be cured with surgery or radiation.
The patient's disease progression will be monitored, unless the disease is newly-diagnosed.
Who else is applying?
What state do they live in?
| Florida | 50.0% |
| California | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Cancer Center of Southern California | 50.0% |
| Moffitt Cancer Center | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
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Conditions
Cancer Related
Treatments