E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with gastrointestinal (colon or gastric) cancer or NSCLC undergoing chemotherapy (treatment of cancer-related cachexia) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective is to explore the efficacy of BST204 in cancer-related cachexia
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to assess safety and tolerability of BST204 in patients with cancer-related cachexia
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Signed informed consent •Ability to understand and follow the requirements of the trial •Diagnosis of advanced GI or NSCLC receiving palliative chemotherapy with a 5-FU or platinum-based regimen, respectively. Or diagnosis of NSCLC receiving intravenous immunotherapy as first-line therapy. •Life expectancy of >6 months at time of screening •Involuntary weight loss of ≥5% body weight within 6 months prior to screening, or of ≥2% with BMI <20 kg/m2 •Eastern Cooperative Oncology Group (ECOG) performance status ≤2 •Age between 18 and 80 years (inclusive) |
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E.4 | Principal exclusion criteria |
The following exclusion criteria will be applied for patients with advanced GI cancer or NSCLC: •Contraindications to ginseng: allergy or hypersensitivity to Panax sp. or their constituents •Ginseng, megestrol, thalidomide, androgenic • steroids (e.g., testosterone, oxandrolone), dronabinol (tetrahydrocannabinoid) or any prescription drug intended to increase appetite or treat weight loss taken within the previous 10 days (or 3 month if extended release) before the first treatment with BST204 (corticosteroids at the time of chemotherapy are allowed) • Tube feeding, parenteral nutrition • Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study • Uncontrolled diabetes mellitus • Ascites or edema, BMI> 30 kg/m2 • Diagnosis of symptomatic tachycardia, arrhythmia, severe angina pectoris, uncontrolled hypertension or heart failure •Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) •Heart rate below 45 or above 100 bpm • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) >5 × upper limit of normal (ULN) • Total bilirubin >2x ULN • Calculated creatinine clearance <30 mL • Uncontrolled pain, hypothyroidism • Major surgery within 4 weeks before randomization visit or planned surgery during the study period • Pregnant or nursing women • Women of childbearing potential not using adequate contraception. Adequate contraception is defined as methods that can achieve a failure rate of less than 1% when used consistently and correctly, such as — combined (estrogen and progesterone-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) — progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) — intrauterine device, intrauterine hormone-releasing system — bilateral tubal occlusion — vasectomized partner (vasectomy at least 3 months prior to screening) — sexual abstinence • Pacemaker |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Physical function: stair climb power changes to baseline after 12 weeks of treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 12 weeks of treatment |
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E.5.2 | Secondary end point(s) |
•Physical function: stair climb power changes to baseline after 4 and 8 weeks of treatment •Lean Body Mass (LBM; bioelectrical impedance analysis [BIA], Dual-energy X-ray absorptiometry [DXA] Note: DXA only after authorization by German national authority): BIA: changes to baseline after 4, 8, and 12 weeks of treatment DXA: changes to baseline after 12 weeks of treatment •Physical function: 6-minute walking test, grip strength after 4, 8, and 12 weeks of treatment •Quality of Life (QoL): changes to baseline in appetite after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Anorexia/Cachexia [FAACT] questionnaire) •Fatigue: changes to baseline after 4, 8, and 12 weeks of treatment in questionnaire scores (Functional Assessment of Chronic Illness Therapy [FACIT] questionnaire) •Adverse events (AEs)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 4, 8, and 12 weeks of treatment |
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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 | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Multicenter, randomized, double-blind, placebo-controlled, four-arm design with two stages |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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The end of the trial will be the date when the clean database is available. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |