A clinical trial that is evaluating how safe and effective an experimental treatment called MORAb-004 is when used in combination with Gemcitabine and Docetaxel in patients diagnosed with Metastatic Soft Tissue Sarcoma.

Phase 1

• Conditions: Metastatic Soft Tissue Sarcoma; MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001399-12-BE
• Lead Sponsor: Morphotek Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Be at least 18 years of age
2.Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
3.Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgroups
4.Have received 0 to 2 prior regimens of systemic treatment for mSTS. Systemic treatment regimens given in the neoadjuvant or adjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for purposes of this protocol. Prior treatment with an anthracycline-based regimen is allowable but not required. (Subjects with extraskeletal small round blue cell sarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy. Subjects with rhabdomyosarcomas must have exhausted or be intolerant of standard first line therapy; anthracycline therapy for rhabdomyosarcoma is allowable but not required.) [French subjects only: Subjects will only be enrolled in the first line setting if (1) there is a contraindication to anthracycline treatment or (2) they have received anthracycline as adjuvant or neoadjuvant treatment.]
5.Have measurable disease, (per RECIST v.1.1) assessed within 30 days prior to the first dose of study drug. Subjects who are receiving second- or third-line therapy must have radiologically documented disease progression (per RECIST v1.1) present within 6 months prior to randomization. For subjects who are receiving first line therapy, no documentation of progression is required.
6.Have an interval between prior cancer treatment and first infusion of test article (MORAb-004 or placebo) of at least 2 weeks (If the immediately prior regimen of cancer treatment included an antibody, a therapeutic protein, or an investigational agent, the minimum interval between prior treatment and first infusion of study drug is 4 weeks.)
7.Have all toxicity (except alopecia) of most recent treatments controlled to a severity of less than or equal to a Grade 1 (mild) prior to administration of test article
8.Have laboratory test results within the 2 weeks prior to Study Day 1 as indicated below
–Absolute neutrophil count at least 1.5 × 109/L
–Platelet count at least 100 × 109/L
–Hemoglobin at least 8 g/dL
–Creatinine no greater than 1.5 × upper limit of normal (ULN) (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Grade 1)
–Bilirubin less than ULN, with the exception of subjects with Gilbert's disease. This inclusion criterion will be waived for subjects with Gilberts disease.
–Aspartate aminotransferase (AST) and alanine aminotransferase (ALT), less than 2.5 × ULN (NCI CTCAE Grade 1) (Additionally, if ALT and/or AST >1.5 × ULN, alkaline phosphatase must be <2.5 × ULN. No adjustments to these criteria are made for subjects with hepatic metastases.)
–Activated partial thromboplastin time (aPTT) and prothrombin time (PT) less than 1.5 × ULN (NCI CTCAE Grade 1) (For subjects who are receiving anticoagulation, the aPTT and INR must be stable and considered baseline for the subject.)
9.Have a life expectancy of at least 3 months, as estimated by the investigator
10.Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
11.Have tumor tissue available for biomarker studies (Tumor tissue from the original diagnostic biopsy is required. Tumor tissue from an optional biopsy of an accessible lesion at Screening may be submitted for bi

Exclusion Criteria

1.Have received more than 2 prior systemic treatment regimens for mSTS
2.Have received either gemcitabine or docetaxel in previous treatment for STS, regardless of the line of treatment
3.Have a diagnosis of primary bone sarcoma of any histologic type
4.Have evidence of active malignancy other than mSTS that required systemic or local treatment within the past 2 years (except basal cell or squamous cell skin cancer)
5.Have any other serious systemic disease (including active bacterial or fungal infection), any medical condition requiring current cytotoxic therapy, or current use of daily chronic (more than 4 consecutive weeks) systemic corticosteroid treatment
6.Have a history of clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4, angina not well-controlled by medication, or myocardial infarction within 6 months), a history of abnormal ejection fraction within the past 6 months (using institutional limits of normal), or a clinically significant arrhythmia on electrocardiograph (ECG) within the past 6 months
7.Have a medical condition with a high risk of bleeding, (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
8.Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
9.Have active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is not exclusionary.)
10.Have a current serious nonhealing wound, an ulcer (including gastrointestinal), or a bone fracture
11.Have a history of allergic reaction to prior monoclonal antibody or biologic agent
12.Have received previous treatment with MORAb-004 (anti-TEM-1)
13.Be currently breastfeeding, pregnant, or likely to become pregnant during the study
14.Have known central nervous system tumor involvement or metastases

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified