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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002028-18 | EudraCT Number |
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This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group A | Experimental | 200 mg Veliparib |
|
| Sequence Group B | Experimental | 400 mg Veliparib |
|
| Sequence Group C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veliparib (ABT-888) | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF) | Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic sampling maximum observed plasma concentration (Cmax) | Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. | |
| Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie Shepherd, PhD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 116015 | Scottsdale | Arizona | 85258 | United States | ||
| Site Reference ID/Investigator# 116016 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27709282 | Result | Munasinghe W, Stodtmann S, Tolcher A, Calvo E, Gordon M, Jalving M, de Vos-Geelen J, Medina D, Bergau D, Nuthalapati S, Hoffman D, Shepherd S, Xiong H. Effect of veliparib (ABT-888) on cardiac repolarization in patients with advanced solid tumors: a randomized, placebo-controlled crossover study. Cancer Chemother Pharmacol. 2016 Nov;78(5):1003-1011. doi: 10.1007/s00280-016-3156-x. Epub 2016 Oct 5. |
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| 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 |
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| ID | Term |
|---|---|
| C521013 | veliparib |
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| Drug |
|
| Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. |
| Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24) | Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. |
| The number of subjects with adverse events | Up to 30 days after last dose of study drug. |
| Vital Signs | Blood pressure, heart rate and temperature. | Up to 30 days after last dose of study drug. |
| Clinical Laboratory Tests | Hematology, chemistry, urinalysis | Up to 30 days after last dose of study drug. |
| Tumor Assessment | A computerized tomography scan will be done at screening to document tumor size. | Screening |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Site Reference ID/Investigator# 117320 | Groningn | 9713 GZ | Netherlands |
| Site Reference ID/Investigator# 117336 | Maastricht | 6229 HX | Netherlands |
| Site Reference ID/Investigator# 117517 | Madrid | 28050 | Spain |
| 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 |