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A Phase 1 Open-Label, Dose-Escalation Study of Veliparib in Combination With Bimonthly FOLFIRI in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Gastric Cancer

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Trial Information

A Phase 1 Open-Label, Dose-Escalation Study of Veliparib in Combination With Bimonthly FOLFIRI in Subjects With Advanced Solid Tumors

Inclusion Criteria:

1. Subject must be at least 18 years of age.

2. Subjects in the dose escalation cohorts must have: * Subjects with histologically
or cytologically confirmed malignancy that is meta static or unresectable and for
which standard curative measures or other therapy that may provide clinical benefit
do not exist or are no longer effective or for whom treatment with FOLFIRI is a
viable option.

3. Subjects in the expanded safety cohort must have: * Histological confirmed advanced
colorectal cancer.

4. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.

5. Subject must have adequate hematologic, renal and hepatic function as follows: *
Bone Marrow: Absolute neutrophil count ANC >= 1,500/mm3; Platelets >= 100,000/mm3;
Hemoglobin >= 9.5 g/dL; * Renal function: Serum creatinine < 1.5 * upper normal
limit of institution's normal range OR creatinine clearance <= 50 mL/min/1.73m2 for
subjects with creatinine levels above institutional normal; * 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. Partial Thromboplastin Time (PTT) must be <= 1.5 * the upper normal limit of
institution's normal range and INR < 1.5. Subjects on anticoagulant (such as
Coumadin) will have PTT and INR as determined by the investigator.

7. Women of childbearing potential must agree to use adequate contraception (one of the
following listed below) prior to study entry, for the duration of study participation
and for 90 days following completion of therapy. Women of childbearing potential
must have a negative serum pregnancy test within 21 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 (minimum one complete menstrual cycle); * Vasectomized partner of
female subjects; * Hormonal contraceptives (oral, parenteral or transdermal) for at
least 3 months prior to study drug administration; * Double-barrier method
(condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or
cream); * IUD (Intra-Uterine Device); * Additionally, 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
completions of therapy.

8. Subject is capable of understanding and complying with parameters as outlined in the
protocol and able to sign and date the informed consent, approved by an Independent
Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of
any screening or study-specific procedures.

9. The subject has received up to 3 prior DNA damaging agents or cytotoxic chemotherapy
treatments (prior therapies with biologic agents including, IL -2, interferon,
vaccines, immunostimulants and signal transduction inhibitors are allowed)
Chemotherapy received as adjuvant therapy before 2 years will not be considered as
prior chemotherapy.

Exclusion Criteria:

1. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy,
radiotherapy, biologic or any investigational therapy within 28 days prior to study
drug administration. Subjects receiving hormone therapy, bisphosphonates or
LHRH-agonists are eligible. Subjects who have not recovered to within one grade
level (not to exceed Grade 2) of their baseline following a significant adverse event
or toxicity attributed to previously anti-cancer treatment are excluded.

2. Subjects in the expanded safety cohorts only, have previously been treated with a
PARP inhibitor.

3. Subjects with a known history of brain metastases and primary CNS tumors

4. Subjects with a known hypersensitivity to CPT11, 5-FU or Folinic Acid.

5. 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. * Gilbert's Syndrome * Any medical condition,
which in the opinion of the study investigator, places the patient at an unacceptably
high risk for toxicities

6. Subjects that are being treated with Ketoconazole, enzyme-inducing anticonvulsants,
and or St. John's Wort.

7. Subject is pregnant or lactating.

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

9. 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.

10. Previous exposure to Irinotecan.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD and establish the recommended phase 2 dose of Veliparib in combination with two different FOLFIRI regimens that include a reduced regimen (150 mg/m2 irinotecan) and the standard regimen (180 mg/m2) in subjects with advanced solid tumors

Outcome Time Frame:

Screening to follow up visit

Safety Issue:


Principal Investigator

Stacie Shepherd, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2010

Completion Date:

October 2014

Related Keywords:

  • Gastric Cancer
  • Gastric Cancer
  • Stomach Neoplasms



Site Reference ID/Investigator# 24987Scottsdale, Arizona  85258
Site Reference ID/Investigator# 24985Los Angeles, California  90033
Site Reference ID/Investigator# 26742Los Angeles, California  90033
Site Reference ID/Investigator# 24986Washington, District of Columbia  20007
Site Reference ID/Investigator# 24922Durham, North Carolina  27710
Site Reference ID/Investigator# 24983Nashville, Tennessee  37232-6307