An open-label phase IIb study to evaluate the safety, tolerability and efficacy of Fotolon® as a nontoxic light-sensitive compound for the local treatment of airway-obstructing non small cell lung cancer by exposing the malign area selectively to light

Phase 1

• Conditions: non small cell lung cancer (NSCLC); MedDRA version: 17.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001876-39-DE
• Lead Sponsor: Apocare Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-28
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Male and female patients aged ? 18 years.
2. Patients with histologic confirmed NSCLC with completely or partially obstructing endobronchial lesions with or without extrabronchial tumor requiring therapy and amenable to bronchoscopic intervention.
3.Patients with tumors, which were already treated with a first line therapy (e.g. chemotherapy), having recurrent, therapy resistant or inoperable tumors.
4.Patients presenting with pulmonary symptoms attributable to the endobronchial lesion (e.g. dyspnea, cough, hemoptysis, retention pneumonia).
5.Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status ?2 at study entry.
6.Patients with an anticipated life expectancy of at least 3 months .
7.Patients with an adequate hematologic capacity, defined by
- WBC ? 3.5 x 109 / l
- Platelets ? 150 x 109 / l
- Hemoglobin ? 10 g / dl.
8.Patients with adequate liver function, defined by
- serum bilirubin ? 2.0 mg / dl
- SGOT, SGPT, GGT ? 3 times ULN.
9.Patients with adequate renal function, defined by
- serum creatinine ? 1.5 mg / dl or
- creatinine clearance ? 60 ml/min.
10.Prothrombin time ? 1.5 x ULN
11.Complete recovery from relevant toxicities of any prior treatment.
12.Effective contraception for women of childbearing potential (< 1% failure rate, combination pill and condom) and for men.
13.Patients must be alert and able to willingly give informed consent.
14.Patients must have given their written informed consent to participate in this study after fully understanding the implications and constraints of the study protocol

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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Women who are pregnant or breast feeding.
2.Women of child-bearing potential not under adequate contraceptive protection (>1% failure rate) and men not executing contraceptive protection.
3.Patients with clinically relevant infection.
4.Past or current history of another malignant disease which has not been curatively treated and has been without evidence of disease for less than 3 years, except non-melanoma skin cancer and in situ carcinoma of the cervix.
5.Porphyria or hypersensitivity against porphyrins or other diseases known to be exacerbated by light.
6.Hypersensitivity to Fotolon® or to any of the excipients of the study medication.
7.Tumors with known or suspected erosion of major blood vessel in or adjacent to the illumination area.
8.Patients with thoracic radiotherapy within the last 4 weeks prior to inclusion in the study.
9.Patients with chemotherapy (including radiochemotherapy) within the last 4 weeks prior to inclusion in the study (Mitomycin C or Nitrosureas: 6 weeks).
10.Patients who have had thoracic surgery within the last 4 weeks.
11.Patients who had other surgery within the last 2 weeks, unless fully recovered.
12.Therapy with another photosensitizing agent in parallel or during the last 4 weeks.
13.Coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days.
14.Patients with known CNS metastases coming along with neurologic signs or symptoms.
15.Patients with psychiatric or other disorders that would interfere with their ability to give written informed consent.
16.Patients who are unable or unwilling to meet the requirements of the protocol.
17.Patients with a known history of drug, medication or alcohol abuse.
18.Patients participating in another study with an investigational medicinal product within less than one month prior to inclusion in the study.
19.Patients with any other condition which is considered by the investigator to bear a high risk of interfering with the drug medication.

Study & Design

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