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This is a multi-cohort, randomized, open, multicenter Phase II study to evaluate the efficacy and safety of AL2846 capsules in patients with advanced lung cancer and ovarian cancer. Objective response rate (ORR) and progression-free survival (PFS) are the primary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL2846 capsule | Experimental | orally administer AL2846 capsules monotherapy, 28 days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL2846 capsule | Drug | AL2846 is a multi-target tyrosine kinase inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective remission rate (ORR) | ORR is defined as the percentage of subjects in complete remission (CR), partial remission (PR), and disease stability (SD). | From baseline up to 12 months. |
| Progression free survival (PFS) | PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause. | From baseline up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | From baseline up to 12 months. |
| Duration of remission (DOR) | The time from the first evaluation as CR or PR to the first evaluation as PD or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
Combined with the following diseases or medical history:
Tumor related symptoms and treatment:
Patients who have participated in and used other antitumor investigational drugs within 4 weeks before the first dose;
Central squamous cell carcinoma (lung cancer subjects) with great risk of hemoptysis;
Patients with concomitant diseases that, in the opinion of the investigators, seriously endanger the safety of the patients or affect the completion of the study, or who are not suitable for inclusion for other reasons.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Changsha | Hunan | 410000 | China | ||
| The Third Xiangya Hospital of Central South University |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| From baseline up to 12 months. |
| Overall survival (OS) | Time from the first administration to death from any cause. | From baseline to the death events, assessed up to 3 years. |
| Adverse events (AEs) rate | Occurrence of all adverse events, regardless of whether there was a causal relation with the studied drug. | From baseline to 28 days after the last dose or initiation of a new antineoplastic therapy (whichever comes first). |
| Peak concentration (Cmax) | Maximum plasma drug concentration | Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days. |
| Time to peak concentration (Tmax) | Time to reach peak plasma drug concentration after dose. | Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days. |
| Clearance half life (t1/2) | The time it takes for the drug concentration in the body to drop by half | Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days. |
| Area under blood concentration-time curve (AUC) | After administration, the area under the curve is obtained using the blood drug concentration as the ordinate and time as the abscissa. | Pre-dose, 30 minutes, 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 12 hours and 24 hours after dose on Day 1 and Day 28 of Cycle 1. Pre-dose on Day 7, Day 14 and 21 of cycle 1. Each cycle is 28 days. |
| Changsha |
| Hunan |
| 410000 |
| China |
| Northern Jiangsu People's Hospital | Yangzhou | Jiangsu | 225009 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |