Evaluating the Safety and Tolerability of the Poly-ADP Ribose (PARP) Inhibitor With FOLFIRI in Subjects With Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Assess whether the combination of ABT-888 with FOLFIRI has activity in subjects with gastric cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

NCT00313872

Gastric Cancer Metastases

COMPLETED PHASE3

A Study of Fluzoparib Given in Combination With Apatinib and Paclitaxel in Gastric Cancer Patients

NCT03026881

Recurrent and Metastatic Gastric Cancer

UNKNOWN PHASE1

Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines

NCT04535401

Advanced Colorectal Carcinoma Advanced Digestive System Carcinoma Advanced Gastric Carcinoma +11 more

ACTIVE_NOT_RECRUITING PHASE1

Phase I/II Clinical Study to Evaluate VB15010 Tablets in Patients With Advanced Solid Tumors

NCT06819215

Cancer Neoplasms Neoplasms, Breast +8 more

RECRUITING PHASE1/PHASE2

Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

NCT01063517

Gastric Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Veliparib and FOLFIRI

Veliparib in combination with FOLFIRI regimen.

Group Type EXPERIMENTAL

Veliparib

Intervention Type DRUG

Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Veliparib

Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-888, Veliparib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No