Study of ENMD-2076 in Patients With Advanced/Metastatic Soft Tissue Sarcoma

NCT01719744 | Completed Phase 2 Results DMC

• 1 other identifier: 2076-STS-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.

Conditions

Advanced; Metastatic; Soft Tissue Sarcoma

Keywords

ENMD-2076; advanced; metastatic; soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• 6-month Progression-free Survival Rate (PFS)

  Number of patients with no progression of disease at 6 months

  From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.

Secondary Outcomes (2)

• Number of and Severity of Adverse Events Per Participant

  2 years

• Objective Response Rate

  From start of study treatment until disease progression or death, whichever occurs first.

Study Arms (1)

ENMD-2076

EXPERIMENTAL

ENMD-2076 capsules, 275 mg once daily, by mouth.

Drug: ENMD-2076

Interventions

ENMD-2076 DRUG

ENMD-2076

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have documented histological diagnosis of soft tissue sarcoma (e.g. leiomyosarcoma, synovial sarcoma, angiosarcoma and liposarcoma etc), with the exception of gastrointestinal stromal tumor (GIST).
• Meet revised RECIST criteria (version 1.1) within 4 weeks of entry by having measurable disease defined as one or more lesions that can be accurately measured in one or more dimensions. Areas of previous radiation may not serve as measurable disease unless there has been objective interval tumor growth documented radiologically.
• Must have had no more than 1 line of treatment in the advanced/metastatic setting. The use of prior anti-angiogenic therapy is allowed. Previous neo-adjuvant or adjuvant therapies are allowed.
• Are at least 3 weeks from major surgery or radiation therapy and recovered; 3 weeks from any other previous anticancer therapy and recovered including biologics.
• Are ≥ 18 years of age
• The patient has a multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal within one month prior to start of study.
• Have clinically acceptable laboratory screening results within certain limits specified below:
• AST and ALT ≤ 2.5 times upper limit of normal (ULN) or less than or equal to 5 times ULN if liver metastases are present
• Total bilirubin ≤ 1.5 x ULN
• Creatinine ≤ 1.5 x ULN or \> 50 ml/min calculated by the Cockcroft and Gault formula (formula defined in appendix E).
• Absolute neutrophil count ≥ 1500 cells/mm3
• Platelets ≥ 100,000/mm3
• Hemoglobin ≥ 9.0 g/dL
• INR ≤ 1.5
• Have an ECOG performance status of 0 or 1.

You may not qualify if:

• Women who are pregnant or nursing
• Have active, acute, or chronic clinically significant infections or bleeding.
• Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); or history of congestive heart failure (equal to or greater than Grade 2 classification by New York Heath Association).
• Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).
• Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 480 msec.
• Have additional uncontrolled serious medical or psychiatric illness.
• Require therapeutic doses of anti-coagulation either by virtue of low-molecular weight heparin or coumadin (prophylactic anti-coagulation allowed). Patients with previous history of deep venous thrombosis or pulmonary embolism are also excluded.
• Known CNS metastases
• Have any medical condition that would impair the administration of oral agents including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled nausea, vomiting or diarrhea
• Have 2+ protein by urinalysis. Patients with an ongoing or previous history of nephrotic syndrome will be excluded
• Have an additional malignancy diagnosed within 5 years of study enrollment with the exception of basal or squamous cell skin cancer or cervical cancer in situ
• Require treatment with drugs known to be potent inducers or inhibitors of CYP3A4 that cannot be substituted
• Patients who cannot or refuse to stop herbal medications of illicit drug use will be excluded from the study. Use of medical marijuana is not permissible in this study.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma

Interventions

ENMD 2076

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. ALBIRUNI RAZAK
• Organization: Princess Margaret Cancer Centre

Albiruni.Razak@uhn.ca

416-586-4800

Study Officials

• Albiruni Razak, MBBS

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 1, 2023
• Results First Posted: November 7, 2017

Record last verified: 2023-07

Locations

CA (1)