An early study to test IMGN901 with carboplatin and etoposide for treating adult patients with certain types of cancer including small cell lung cancer
- Conditions
- Phase 2: small cell lung cancer (extensive-stage disease)MedDRA version: 14.1 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 100000004864MedDRA version: 14.1 Level: LLT Classification code 10041058 Term: Small cell carcinoma of the lung System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022950-17-GB
- Lead Sponsor
- ImmunoGen, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 181
1. Male or female patients =18 years old at the time of signing Informed Consent
2. Diagnosis
• Patients with histologically or cytologically confirmed SCLC and extensive disease as defined by the Veterans Administration Lung Cancer Group
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
4. Prior therapy
• No prior systemic chemotherapy for the treatment of SCLC
• Previous radiotherapy, including cranial irradiation, is allowed if < 30% of marrow-bearing bones were irradiated and if radiotherapy was completed at least 7 days prior to enrollment and the patient has recovered or stabilized from all adverse effects of prior radiotherapy
5. Major surgery (this does not include placement of vascular access device or tumor biopsies) must be completed 4 weeks prior to Day 1
6. Patients must have at least one measurable lesion per RECIST 1.1 guidelines for solid tumors.
7. Patients must have the following laboratory values:
• Absolute Neutrophil Count (ANC) = 1.5 x 109/L (1500/mm3)
• Platelets =100.0 x 109/L (100,000/mm3)
• Hemoglobin (Hgb) =9 g/dL
• Serum total bilirubin =1.5 x ULN (upper limit of normal)
• AST (SGOT) and ALT (SGPT) =2.5 x ULN, except for patients with tumor involvement of the liver who must have AST and ALT =5 x ULN
• Serum creatinine =1.5 x ULN or 24-hour creatinine clearance =60 mL/min
• Amylase and lipase must be =1.5 x ULN
8. Patients must be willing and able to adhere to the study visit schedule and other protocol requirements
9. Patients or a legally authorized representative must understand and voluntarily sign an Informed Consent
10. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use 2 contraceptive methods (e.g., oral, parenteral, or implantable hormonal contraceptive; tubal ligation; intra-uterine device;
barrier contraceptive with spermicide; partner's latex condom or vasectomy). WCBP must agree to follow these requirements for at least 4 weeks after the last dose of study drug
11. WCBP must have a negative pregnancy test prior to the first dose of study treatment
12. Male patients must agree to use a latex condom even if he has had a successful vasectomy and continue to follow these requirements for at least 4 weeks following the last dose of study drug
13. Predicted survival of 3 months or more
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 88
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72
1. Concurrently receiving other anti-neoplastic treatment (e.g. chemotherapy, investigational therapy or immunotherapy including steroid therapy)
2. Grade =2 neurotoxicity
3. Any serious medical condition including laboratory abnormalities, or psychiatric disorder that in the opinion of the Investigator places a patient at unacceptable risk if he/she were to participate in the study
4. Clinically relevant active infection including known active hepatitis B or C, Human Immunodeficiency Virus (HIV) infection, varicella-zoster virus (shingles) or cytomegalovirus infection or any other known concurrent infectious disease which, in the judgment of the Investigator, would make a patient inappropriate for enrollment into this study
5. Significant cardiac disease such as recent myocardial infarction (=6 months prior to Day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension (recurrent or persistent increases in systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg ), uncontrolled cardiac arrhythmias, severe aortic stenosis, or = grade 3 cardiac toxicity following prior chemotherapy
6. History of neurologic disease such as multiple sclerosis or other demyelinating disease; paraneoplastic neurologic syndrome such as Eaton-Lambert syndrome, encephalomyelitis or sensory neuropathy;
central nervous system (CNS) injury with residual neurological deficit; or has a history of hemorrhagic or ischemic stroke within the last 6 months
7. Patients with CNS metastases excluded unless previously treated with surgery or radiation and on stable, decreasing or no steroids. Patients with asymptomatic CNS metastases are eligible unless requiring steroids, anticonvulsants or other treatments to manage their CNS disease.
8. Patients with uncontrolled carcinoid syndrome (flushing, uncontrolled diarrhea, labile blood pressure)
9. Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids
10. Patients with previous history of hypersensitivity or anaphylactic reaction to IMGN901 or any of its excipients
11. Patients with previous history of hypersensitivity to etoposide or any component of its formulation
12. Patients with previous history of allergic reaction to platinum-containing compounds
13. Prior active malignancy within the last 3 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer
14. Patients with a history of chronic pancreatitis or metastatic disease involving the pancreas that has been associated with an increased amylase and/or lipase
15. WCBP who are pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The primary objective is to determine the efficacy of IMGN901 in combination with carboplatin/etoposide chemotherapy followed by<br> IMGN901 alone as first-line treatment for patients with extensive stage small cell lung cancer (SCLC-ED).<br> ;<br> Secondary Objective: The secondary objectives are to determine the safety and tolerability of IMGN901 in combination with carboplatin/etoposide<br> chemotherapy followed by IMGN901 alone versus carboplatin/etoposide chemotherapy and to assess the immunogenicity of IMGN901 in combination with carboplatin.<br> ;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: Phase 2: 2 years after enrollment of last patient
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. Overall survival<br> 2. PFS<br> 3. TTP<br> 4. ORR<br> 5. Toxicity and tolerability<br> 6. OS<br> 7. PK parameters (for patients enrolled prior to Amendment 4)<br> 8. Presence of HAHA and HADA in arm 1<br> 9. Measurement of cytokines<br> ;<br> Timepoint(s) of evaluation of this end point: 1. 2 years after enrollment of last patient<br> 2. 6 months<br> 3. At scheduled visits<br> 4. At scheduled visits<br> 5. At scheduled visits<br> 6. 12 months<br> 7. Days 1, 2, 3, 8, 9 cycle 1, Days 1, 2, 3 cycle 4<br> 8. Day 1 cycles 1, 4, 10, 15<br> 9. Pre-dose day 1 & 8 of cycle 1 of Phase 2<br>