NL-OMON39691
Completed
Phase 2
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma - MORAb-004 in Metastatic Soft Tissue Sarcoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- soft tissue cancer
- Sponsor
- Morphotek, Inc
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 been treated in the metastatic setting with 0 to 2 prior systemic regimens 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.
- •5\. Have measurable disease, as defined by 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 of immediately prior treatments, except alopecia, controlled to a severity of less than or equal to Grade 1 (mild)
- •8\. Have laboratory test results within the 2 weeks prior to Study Day 1 as indicated below
- •\* Absolute neutrophil count at least 1\.0 × 109/L
Exclusion Criteria
- •1\. Have received more than 2 prior systemic treatment regimens for mSTS
- •2\. Have received either gemcitabine or docetaxel in any 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, or any medical condition requiring current cytotoxic therapy or current 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 the past 6 months), a history of abnormal ejection fraction within the past 6 months, using institutional limits of normal), or clinically significant arrhythmia on electrocardiograph (ECG) within the past 6 months
- •7\. Have a medical condition with a high risk of bleeding 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 dsurgical procedures anticipated during the study.
- •9\. Have active viral hepatitis or symptomatic HIV infection (Asymptomatic positive serology is acceptable)
- •10\. Have a current serious non\-healing would, and ulcer or bone fracture.
Outcomes
Primary Outcomes
Not specified
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