Phase 2 N=20 Treatment

Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide

Soft-tissue Sarcomas

Bottom Line

View on ClinicalTrials.gov: NCT02805725 ↗

Enrolled (actual)

Serious AEs

56.5%

Results posted

Mar 2023

Primary outcome: Primary: Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP. — 0.50 mg/m^2

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Phase 1: Trabectedin (Drug); Phase 2: Trabectedin (Drug); Phase 1: Cyclophosphamide (Drug); Phase 2: Cyclophosphamide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Institut Bergonié
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase I: Maximum Tolerated Dose (MTD) of Trabectedin When Administered in Association With CP.	0.50	—
PRIMARY Phase I: Number of Patients Who Experienced Dose-Limiting Toxicities (DLTs)	0; 0; 0; 2	—
PRIMARY Phase II: Percentage of Patients in Non-progression at 6 Months (RECIST V1.1)	23.1; 12.5	—
SECONDARY Phase I: Percentage of Patients With Objective Response (RECIST V1.1)	0; 0; 0; 0	—
SECONDARY Phase II: Median Overall Survival	12.0	—
SECONDARY Phase II: Median Profression-free Survival	1.9	—

Summary

Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).

Eligibility Criteria

Inclusion Criteria

Patients with soft-tissue sarcoma histologically confirmed by central review
Metastatic or unresectable locally advanced disease,
Age ≥ 18 years,
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2,
Life expectancy > 3 months,
Measurable disease according to RECIST v1.1 outside any previously irradiated field,
For patients included in phase II study, progressive disease according to RECIST v1.1 criteria diagnosed on the basis of two CT scan or MRI obtained at an interval less than 6 months in the period of 12 months prior to inclusion and confirmed by central review,
Previous use of Anthracyclines,
Have provided tissue from an archival tissue sample,
At least three weeks since last chemotherapy, immunotherapy or any other pharmacological treatment and/or radiotherapy,
Adequate hematological, renal, metabolic and hepatic function:
Hemoglobin ≥ 9 g/dl (patients may have received prior red blood cell [RBC] transfusion, if clinically indicated); absolute neutrophil count (ANC) ≥ 1.5 x 10^9/l, and platelet count ≥ 100 x 10^9/l
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) grade 2 CTC [CTCAE] HIV1, HIV2, hepatitis B or hepatitis C infections,
History of chronic alcohol use and/or cirrhosis,
The following unstable cardiac conditions are not allowed:
Congestive heart failure
Angina pectoris
Myocardial infarction within 1 year before registration
Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mmHg despite optimal medical therapy
Arrhythmias clinically significant
Patients unable to receive corticotherapy,
Known central nervous system malignancy (CNS),
Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
Participation to a study involving a medical or therapeutic intervention in the last 30 days,
Previous enrolment in the present study,
Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
Known hypersensitivity to any involved study drug or any of its formulation components.
Recent vaccination (in the last 2 weeks before inclusion) for yellow fever.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02805725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.