E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent extensive small cell lung cancer after first-line platinum-based therapy. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041067 |
E.1.2 | Term | Small cell lung cancer |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the objective overall response rate (complete plus partial responses). |
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E.2.2 | Secondary objectives of the trial |
• To determine the rates of stable disease (SD) and progressive disease (PD). • To determine time to progression (TTP). • To determine progression-free survival (PFS). • To determine overall survival (OS). • To evaluate the treatment-related toxicities in this patient population. • To determine the pharmacokinetic (PK) profile of INNO-206 in a minimum of 12 patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must meet all of the following criteria for admission into the study:
(1) Informed consent must be obtained in writing for all patients prior to enrollment into the study.
(2) Be greater than or equal to 18 years old. In Germany, patients must be less than or equal to 70 years old when consent is obtained.
(3) Have a histologically or cytologically confirmed diagnosis of recurrent extensive small cell lung cancer (SCLC) at time of enrollment into the study.
(4) Have responded to first-line platinum-based chemotherapy, but progressed or relapsed greater than or equal to 60 days after completion of first-line therapy.
(5) Have measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
(6) Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2.
(7) Have an estimated life expectancy of greater than or equal to 4 weeks.
(8) Be male or non-pregnant, non-lactating female patients. For US patients who are fertile, they must agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study medication. For all non-US patients, who are fertile, they must agree to use two forms of barrier method contraception (e.g., latex condom AND a diaphragm or cervical cap) while on therapy and for 90 days following the discontinuation of the study medication. A non-fertile female is defined as: -- Postmenopausal (amenorrheic for greater than or equal to 12 months) -- Undergone a complete oopherectomy and hysterectomy
(9) Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study medication (if patient is a female of childbearing potential).
(10) Have adequate organ function as indicated by the laboratory values specified in the protocol obtained within 14 days prior to the first dose of study drug.
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E.4 | Principal exclusion criteria |
Patients who meet any of the following criteria will be excluded from study admission:
(1) Are pregnant, lactating, or had childbirth within 6 months prior to study entry.
(2) Have received prior anthracycline therapy.
(3) Have participated in any investigational drug study within 30 days prior to study entry.
(4) Have received radiotherapy within 2 weeks (14 days) of treatment in this study.
(5) Have not recovered from acute toxicity of all previous therapy prior to enrollment.
(6) Have a history of a malignancy other than SCLC; exceptions to this include: -- Curatively treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix; or prior low-grade, localized prostate cancer (Gleason score less than or equal to 6). -- History of another malignancy that was curatively treated and no evidence of recurrence for a minimum of 5 years.
(7) Have symptomatic central nervous system (CNS) metastases.
(8) Have any concurrent severe or uncontrolled medical disease (such as active systemic infection, hypertension, congestive heart failure ≥NYHA Grade II, myocardial infarction within 6 months before study start, severe rhythm disturbances including arrhythmias with negative hemodynamic effects, acute inflammatory heart disease) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
(9) Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
(10) Have received radiotherapy with >25% involvement of the bone marrow within 6 weeks prior to study start.
(11) Have a known hypersensitivity to doxorubicin, other anthracyclines, 5% D-(+)-sucrose, 10 mM sodium phosphate, and/or 0.3% N acetyltryptophane.
(12) In Germany, the following exclusion criteria also apply: a. Have hemorrhagic diathesim, b. Have active stomatides, c. Have active generalized infection, d. Have distinct myelosuppression (for example after previous radiotherapy or chemotherapy), or e. Have severe liver dysfunction.
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete and partial disease responses will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |