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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Oncology, BRCA Mutated, High Grade Serous Ovarian Cancer, BRCA Mutated Breast Cancer

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Trial Information

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


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. Part 3: Histologically or cytologically confirmed
breast or ovarian 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.

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.

- total abstinence from sexual intercourse as the preferred life style of the
subject; periodic abstinence is not acceptable;

- vasectomized partner(s);

- hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months
prior to study drug administration;

- intrauterine device (IUD);

- Male subjects (including those who are vasectomized) whose partners are pregnant
or might be pregnant must agree to use condoms for the duration of the study and
for 90 days following completion if therapy.

7. Subject must be capable of understanding and complying with parameters as outlined in
the protocol and able to sign informed consent, approved by an Institutional Review
Board (IRB) prior to the initiation of any screening or study specific procedures.

8. Must voluntarily sign and date each informed consent, approved by an Independent
Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of
any screening or study-specific procedures.

Exclusion Criteria:

1. The subject must not have received anti-tumor radiotherapy, biologic therapy,
chemotherapy, or immunotherapy within 28 days 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;

5. Subject is pregnant or lactating.

6. Subjects that have previously been treated with a veliparib.

7. For Part 3, subject has ovarian cancer that was previously treated with platinum
based chemotherapy resulting in progression free survival for < 6 months from the
completion of treatment.

8. For Part 3, subject has received 4 or more prior lines of cytotoxic chemotherapy for
systemic disease.

9. Subject who requires parenteral nutrition, tube feeding or has evidence of partial
bowel obstruction or perforation within 28 days prior to study drug administration.

10. The subject has had another active malignancy within the past 3 years except for any
cancer in situ that the Principal Investigator considers to be cured. Questions
regarding the inclusion of individual subject should be directed to the Medical
Monitor.

11. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that
might interfere with gastrointestinal motility, pH or absorption.

12. Receipt of any investigational product within 6 weeks prior to study drug
administration or 5 half-lives, whichever is longer.

13. Current enrollment in another clinical study.

14. Consideration by the investigator, for any reason, that the subject is an unsuitable
candidate to receive veliparib.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 2 - Dose Escalation Cohort: Pharmacokinetic testing

Outcome Description:

Cmax, Tmax ,and AUC, and safety parameters

Outcome Time Frame:

Up to 36 months

Safety Issue:

Yes

Principal Investigator

Mark McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M13-695

NCT ID:

NCT01853306

Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Oncology
  • BRCA Mutated
  • High Grade Serous Ovarian Cancer
  • BRCA Mutated Breast Cancer
  • Oncology
  • High grade serous ovarian cancer
  • BRCA mutated breast cancer
  • BRCA mutated
  • Breast Neoplasms
  • Ovarian Neoplasms

Name

Location

Site Reference ID/Investigator# 89594Scottsdale, Arizona  85258
Site Reference ID/Investigator# 89593Detroit, Michigan  48201
Site Reference ID/Investigator# 89834Hackensack, New Jersey  07601
Site Reference ID/Investigator# 89595New Brunswick, New Jersey  08901
Site Reference ID/Investigator# 89596Salt Lake City, Utah  84112