Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Affiliated Hospital of the Chinese Academy of Military Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib + Apatinib + Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Fluzoparib either at 20,30,40mg twice daily,capsule oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis. | DLT and safety defined by CTC version 4.0 | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best of ORR | through study completion, an average of 6 months | |
| Overall Response Rate (ORR) | through study completion, an average of 6 months | |
| Disease Control Rate (DOR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianming Xu, MD | Contact | jmxu2003@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Military Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100039 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| C553458 | apatinib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Apatinib | Drug | Oral |
|
| Paclitaxel | Drug | Intravenous injection |
|
| through study completion, an average of 6 months |
| Time to Progression (TTP) | From date of enrollment until the date of first objective progression, assessed up to 9 months |
| Progression Free Survival (PFS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months |
| Maximum plasma concentration (Cmax) | Up to 33 days |
| Terminal half life (t1/2) | Up to 33 days |
| Area under the plasma concentration-time curve (AUC) | Up to 33 days |
| Volume of distribution (V/F) | Up to 33 days |
| Plasma Clearance (CL/F) | Up to 33 days |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |