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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.
Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.
Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin, Pemetrexed, Debio 0932 | Experimental | Cisplatin, Pemetrexed, Debio 0932 |
|
| Cisplatin, Gemcitabine, Debio 0932 | Experimental | Cisplatin, Gemcitabine, Debio 0932 |
|
| Docetaxel, Debio 0932 | Experimental | Docetaxel, Debio 0932 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Debio 0932 | Drug | Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Dose Limiting Toxicities | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Day 1 of each treatment cycle until disease progression or study drug toxicity | |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Every treatment cycle until disease progression or study drug toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Isambert, MD | Centre GF Leclerc, Dijon, France | Principal Investigator |
| Jean-Pierre Delord, PR | Institut Claudius Regaud, Toulouse, France | Principal Investigator |
| Jèrôme Fayette, MD | Centre Léon Bérard, Lyon, France | Principal Investigator |
| Jaafar Bennouma, MD | Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, France | Principal Investigator |
| Luis Paz-Ares, PR | Hospital Universitario Virgen del Rocío, Seville, Spain | Principal Investigator |
| Enriqueta Felip, PR | Hospital Universitari Vall d'Hebron, Barcelone, Spain | Principal Investigator |
| Mariano Provencio, PR | Hospital Puerta de Hierro Majadahonda, Madrid, Spain | Principal Investigator |
| Ruth Plummer, PR | Freeman Hospital, Newcastle, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre GF Leclerc | Dijon | France | ||||
| Centre Léon Bérard |
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| Label | URL |
|---|---|
| Site Debiopharm SA | View source |
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| Cisplatin | Drug | Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle. |
|
| Pemetrexed | Drug | Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle. |
|
| Gemcitabine | Drug | Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle. |
|
| Docetaxel | Drug | Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle. |
|
| Incidence of laboratory abnormalities | 2 to 4 times every treatment cycle until disease progression or study drug toxicity |
| Incidence of treatment discontinuations due to AEs and SAEs | Every treatment cycle until diseases progression or study drug toxicity |
| Change in left ventricular ejection fraction (LVEF) | Baseline and after 4 weeks of treatment |
| Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1 | 22 days |
| Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel | 22 days |
| Best overall tumor response | 22 days |
| Pharmacodynamic biomarkers | 22 days |
| Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932 | 7 days |
| Lyon |
| France |
| Institut de Cancérologie de l'Ouest- Institut René Gauduchau | Nantes | France |
| Institut Claudius Regaud | Toulouse | France |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Puerta de Hierro Majadahonda | Madrid | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Freeman Hospital | Newcastle | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C543177 | CUDC 305 |
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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