A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma - MORAb-004-203 Soft Tissue Sarcoma Study

Morphotek Inc.0 sites200 target enrollmentSeptember 2, 2013

ConditionsMetastatic 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]

DrugsGemcitabine SUN 1000 mg, powder for solution for infusion Docetaxel Actavis 20mg/ml Concentrate for Solution for Infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Soft Tissue Sarcoma
Sponsor: Morphotek Inc.
Enrollment: 200
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 2, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Morphotek Inc.

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 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

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