Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003137-16 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - Veliparib Monotherapy | Experimental | Subjects in this arm will be dosed with Veliparib continuous dosing. |
|
| Arm B - Veliparib in Combination with Carboplatin & Paclitaxel | Experimental | Subjects enrolled will receive Veliparib in combination with Carboplatin and Paclitaxel and have an option to move to Veliparib monotherapy. |
|
| Arm C Veliparib in Combination with Modified FOLFIRI | Experimental | Subjects will be given Veliparib in combination with modified FOLFIRI. The subject will have the opportunity to receive Veliparib as monotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Measured up to 30 days after the last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months. | |
| Overall Survival (OS) | Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stacie Shepherd, PhD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 117416 | Scottsdale | Arizona | 85258 | United States | ||
| Site Reference ID/Investigator# 117415 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin | Drug |
|
| Paclitaxel | Drug |
|
|
| FOLFIRI | Drug | combination of Fluorouracil, leucovorin and irinotecan |
|
| Time to Disease Progression (TTP) | Assessed at each visit up to 18 months after the last subject has enrolled in the study. |
| Progression Free Survival (PFS) | Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study. |
| Clinical Laboratory Tests | Hematology, Chemistry, Urinalysis | Up to 18 months. |
| Electrocardiogram | Up to 18 months. |
| Tumor Assessment | A computerized tomography scan to document the size of the tumor. | Up to 18 months. |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Site Reference ID/Investigator# 117337 | Groningen | 9713 GZ | Netherlands |
| Site Reference ID/Investigator# 117338 | Maastricht | 6229 HX | Netherlands |
| Site Reference ID/Investigator# 117451 | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D003110 | Colonic Neoplasms |
| D008175 | Lung Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C521013 | veliparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| C480833 | IFL protocol |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided