An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma

Phase 2

Recruiting

Conditions: 10027412
asbestosis
pleural cancer

Registration Number: NL-OMON37190

Lead Sponsor: Morphotek Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

- >= 18 years of age
- Life expectancy of at least 3 months
- Confirmed diagnosis of MPM with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); or epithelial type or biphasic (mixed) type with low sarcomatous content).
- Measurable disease at Screening
- Karnofsky performance status of >= 70% at Screening
- Other significant medical conditions must be well-controlled and stable
- Laboratory results must be within a certain range (see page 26)
- serum creatinine clearance >= 60 mL/min
- Subjects must be sterile or using adequate contraception during the study and for at least 8 weeks after the last dose of MORAb-009
- willing and able to sign informed consent

Exclusion Criteria

- Sarcomatous type of mesothelioma
- Prior systemic therapy or radiotherapy
- central nervous system (CNS) tumor involvement
- other active malignancy requiring treatment
- clinically significant heart disease or arrhythmias
- hepatitis or HIV infection
- active serious systemic disease
- Treatment within 3 months of the start of the trial with other immunomodulatory therapy
- hypersensitivity to one of the medications which will be administered
- breast-feeding, pregnant, or likely to become pregnant
- not willing or unable to sign informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is PFS at 6 months. PFS is defined as time from<br /><br>the date of first dose of MORAb-009 to the date of disease progression or death<br /><br>due to any cause. A response, in terms of PFS, is defined to be at least a 6<br /><br>month stabilization of disease.<br /><br><br /><br>Safety endpoints (protocol 9.6, page 66) include<br /><br>- assessment of incidence and severity of AEs, including clinical laboratory<br /><br>parameters, physical examination, ECG, pulmonary function testing and HACA<br /><br>development.<br /><br>- Tolerability of treatment: The number of subjects discontinuing treatment due<br /><br>to toxicity and the number of subjects who delay treatment or skip all or part<br /><br>of cycles of treatment due to toxicity and the extent of delays.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary efficacy endpoints are (protocol 9.5, page 66):<br /><br>- ORR (defined as the proportion of subjects with a partial response (PR) or<br /><br>complete response (CR))<br /><br>- duration of this response (defined as as the time from first documentation of<br /><br>objective tumor response to the first documentation of objective tumor<br /><br>progression or to death due to any cause)<br /><br>- overall survival (defined as the time from the date of the first dose of<br /><br>MORAb-009 to the date of death)<br /><br>- overall median progression free survival<br /><br>- To determine the safety and tolerability of MORAb-009 when administered with<br /><br>pemetrexed and cisplatin.<br /><br><br /><br>Exploratory endpoints:<br /><br>- Change in CA-125 Levels<br /><br>- Change in Karnofsky Performance Status<br /><br>- Analysis of survival by HLA subtype (if sufficient data on HLA subtype are<br /><br>available)<br /><br>- Molecular marker analysis </p><br>