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A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib Extended Release Formulations in Subjects With Solid Tumors

NCT01853306•AbbVie

View on ClinicalTrials.gov

Summary

This is a 3 part phase 1 study to evaluate the safety, pharmacokinetic and oral bioavailability of veliparib in subjects with solid tumors.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Part 1 and 2: Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator, OR 2) have high grade serous ovarian, fallopian tube, or peritoneal cancer. Subjects with molecular features indicative of DNA repair defects (such as mutation in the Fanconi anemia pathway genes or methylation of the BRCA1 promoter) may be considered eligible for following discussion with the medical monitor. Part 3: Histologically or cytologically confirmed breast, ovarian, fallopian tube or primary peritoneal cancer that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective. Platinum-resistant ovarian cancer is not permitted. Subjects must also 1) have a documented BRCA1 or BRCA2 mutation that is considered to be deleterious by the investigator and 2) have received 3 or fewer regimens of cytotoxic chemotherapy in the metastatic setting and 3) have evaluable disease as defined by RECIST 1.1 or GCIC-CA-125 criteria.
•2. Subject must be at least 18 years of age.
•3. Completion of last anti-cancer therapy must be at least 28 days prior to study drug administration.
•4. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
•5. Subject must have adequate hematologic, renal and hepatic function as follows:
•* Bone Marrow: Absolute neutrophil count ANC ≥ 1,500/mm3 (1.5 × 109/L); Platelets ≥ 100,000/mm3 (100 × 109/L); Hemoglobin ≥ 9.5 g/dL (1.4 mmol/L). Subjects with hemoglobin ≥ 9.5 g/dL (1.4 mmol/L) following transfusion are eligible;
•* Renal function: A calculated creatinine clearance value of ≥ 50 mL/min as determined by the Cockcroft Gault formula or a creatinine clearance value of ≥ 50 mL/min based on a 24-hour urine collection;
•* Hepatic function: AST and ALT ≤ 2.5 × the upper normal limit of institution's normal range. For subjects with liver metastases, AST and ALT ≤ 5 × the upper normal limit of institution's normal range;
•* Bilirubin: → 1.5 × the upper normal limit of institution's normal range.
•6. Women of childbearing potential and men must agree to use adequate contraception prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
+7 more criteria

Exclusion Criteria

•1. The subject must not have received anti-tumor radiotherapy, biologic therapy, chemotherapy, or immunotherapy within 28 days or 5 half lives (whichever is shorter) of the start of Day 1. The subject must not have received hormonal therapy for anti-tumor purposes within 1 week prior to the start of Cycle 1 Day 1.
•2. Subject must not have known untreated brain or meningeal metastases. CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease. Subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, provided that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least one week prior to study drug administration).
•3. Clinically significant and uncontrolled major medical condition(s) including but not limited to:
•* Uncontrolled nausea/vomiting/diarrhea;
•* Active uncontrolled infection;
•* Symptomatic congestive heart failure;
•* Unstable angina pectoris or cardiac arrhythmia;
•* Psychiatric illness/social situation that would limit compliance with study requirements;
•* Focal or generalized seizure within the last 12 months.
•4. Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities;
+11 more criteria

Key Dates

Start Date

March 18, 2013

Primary Completion Date

May 3, 2017

Completion Date

June 29, 2017

Last Updated

November 21, 2017

Enrollment

ACTUAL participants

Conditions

OncologyBRCA MutatedHigh Grade Serous Ovarian CancerBRCA Mutated Breast Cancer

Interventions

Veliparib

DRUG

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RECRUITING

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors

Inclusion Criteria

Exclusion Criteria

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