Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma Biliary carcinoma

Phase 1

• Conditions: Treatment of Therapy refractory none small cell lung Cancer (NSCLC), small cell lung Cancer (SCLC) and Biliary carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002378-30-DE
• Lead Sponsor: CellAct Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-29
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Age = 18 years
?ECOG Performance Status of 0-2
?Life expectancy of at least 8 weeks
?Adequate bone marrow and organ function including:
?Hemoglobin = 9.0 g/dL
?Absolute neutrophil count (ANC) = 1,500/mm3
?Platelet count = 100,000/mm3
?Total bilirubin = 1.5 times the upper limit of normal (ULN)
?ALT and AST = 2.5 x ULN (= 5 x ULN for patients with liver involvement)
?PT-INR and PTT < 1.5 x ULN
?Creatinine clearance (CrCl) >50 mL/min (according to modified Cockcroft-Gault criteria: CrCl = Wt (kg) × (140-age)/72 × Creatinine level, male x 1, female × 0.85)
?Must have recovered from the acute reversible effects of previous anti-cancer chemotherapy, usually 3-4 weeks after myelosuppressive chemotherapy.
?Patients with a history of brain metastasis are eligible provided they have been adequately treated with surgery, radiotherapy and steroids, and are presently stable without evidence of disease. These patients may be receiving low dose glucocorticoids provided the dose has been stable for at least two weeks prior to starting study medication
?Medically controlled, negative pregnancy test in all women except those who were surgically sterile or at least one year postmenopausal
Female patients of child-bearing potential are eligible, if they agree to use a highly effective method of birth control throughout the study and for at least 4 weeks after stopping treatment
Male patients with partners of child-bearing potential are eligible, if they agree to use barrier contraception during the trial and for 6 months after stopping study drug, unless surgically sterile.
?Written informed consent according to ICH-GCP, and national/local regulations
?High probability of a good compliance and orderly completion of the study

Additional inclusion criteria specific for NSCLC
?Histologically- or cytologically-confirmed diagnosis of NSCLC with Stage IIIB or IV after failure of at least two lines of therapy
?At least one measurable lesion according to RECIST criteria version 1.1.
?Documented disease progression (RECIST) after last therapy
?Prior therapy with two lines of chemotherapy for advanced disease one of which should have consisted of a platin based combination regimen
?Patients with tumors known to have mutated EGFR must have received one line of EGFR inhibitor therapy in addition to one only line of chemotherapy for advanced disease
?Patients whose tumors are known to have an ALK translocation or ROS1 activation must have received one line of therapy with an ALK inhibitor in addition to one only line of chemotherapy for advanced disease
?Patients may have received an additional regimen as neo/adjuvant chemotherapy as part of treatment for early disease
?Patients may have received prior maintenance therapy
?Prior Radiotherapy is acceptable provided it involved <25% of red bone marrow. At least one week should have elapsed from completion of prior radiotherapy and the patient must have recovered from acute toxic effects. If the measurable lesions(s) are in the field of radiotherapy at least 6 weeks should have elapsed from completion or radiotherapy, and progression must be confirmed radiologically
?Radiotherapy for isolated (bone) lesions is permitted during the study
Additional inclusion criteria specific for SCLC
?Histologically- or cytologically-confirmed, limited and extensive SCLC disease, with documented progression.
?At least one measurable lesion according to RECIST criteri

Exclusion Criteria

NSCLC, SCLC and Biliary Carcinomas
?Serious concurrent medical condition, which could affect compliance with the protocol or interpretation of results.
?Patients with uncontrolled infection and patients known to be infected with the human immunodeficiency virus (HIV) or with chronic hepatitis B or hepatitis C virus infection are not eligible for the study
?Other psychological or social conditions which in the investigator’s opinion would not make the patient a good candidate for the clinical trial
?Pregnancy or breast-feeding
?Participation in another clinical trial within 30 days prior to the screening visit
?Patients who are committed to an institution according to an order of court or an official directive
?Receiving other anti-cancer therapies
?Patients who are committed to an institution according to an order of court or an official directive.
Additional exclusion criteria for NSCLC and SCLC
?Uncontrolled pleural effusion
?Receiving other anti-cancer therapies except Bisphosphonates (or denosumab).
Additional exclusion criteria specific for NSCLC only
?Patients eligible for EGFR therapy or ALK inhibitor therapy
?History of another malignancy which could affect compliance with the protocol or interpretation of results. Patients who have been treated with curative intent and remained disease-free for at least 3 years are generally eligible, as are patients with in situ disease treated with curative intent.
Additional exclusion criteria specific for SCLC only
?History of another malignancy which could affect compliance with the protocol or interpretation of results. Patients who have been treated with curative intent and remained disease-free for at least 5 years are generally eligible, as are patients with in situ disease treated with curative intent.

Study & Design

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