Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003427-36 | 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
A Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC).
Subjects will be randomized in a 2:1 ratio to one of the two treatment groups. The safety of each treatment group will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, changes in laboratory determinations and vital sign parameters. Progression -Free Survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) will be assessed as well as Overall Survival (OS) and the Objective Response Rate (ORR). Study visits will be conducted according to the protocol schedule. Study visits will include physical examination, laboratory blood sample collection, and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram (ECG) will be performed at protocol specified visits.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| veliparib and carboplatin and paclitaxel | Experimental | Veliparib on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle |
|
| placebo and carboplatin and paclitaxel | Placebo Comparator | Placebo on Days 1-7 and carboplatin and paclitaxel on Day 3 of a 21 day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib | Drug |
|
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Continuously from date of randomization until date of death from any cause or until patient is registered as off study, whichever came first. | Monthly after patient is registered off study up to 36 months or until date of death from any cause, whichever came first. |
| Objective Response Rate (ORR) |
Not provided
Inclusion Criteria: - Life expectancy > 12 weeks (as per Investigator's clinical assessment).
Exclusion Criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vincent Giranda, MD | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27803064 | Derived | Ramalingam SS, Blais N, Mazieres J, Reck M, Jones CM, Juhasz E, Urban L, Orlov S, Barlesi F, Kio E, Keiholz U, Qin Q, Qian J, Nickner C, Dziubinski J, Xiong H, Ansell P, McKee M, Giranda V, Gorbunova V. Randomized, Placebo-Controlled, Phase II Study of Veliparib in Combination with Carboplatin and Paclitaxel for Advanced/Metastatic Non-Small Cell Lung Cancer. Clin Cancer Res. 2017 Apr 15;23(8):1937-1944. doi: 10.1158/1078-0432.CCR-15-3069. Epub 2016 Oct 10. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 29, 2021 | |
| Reset | Aug 20, 2021 |
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| paclitaxel | Drug |
|
| placebo | Drug |
|
| Radiographic evaluation starting from the third day of study treatment and on average every 6 weeks until documented progression or date of death from any cause, whichever came first, until patient is registered as off study. |
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | From date of screening, first day of study treatment and then every cycle (about every 3 weeks) until date of death from any cause or patient is registered as off study, whichever came first. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 29, 2021 | Aug 20, 2021 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C521013 | veliparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| 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