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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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People are being asked to participate in this study who have metastatic pancreatic cancer (cancer that has spread to other parts of the body).
The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and mFOLFOX-6 (modified 5-Fluorouracil and Oxaliplatin) for patients with metastatic pancreatic cancer.
ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the mFOLFOX-6, and will hopefully increase the killing of cancer cells, thus decreasing the tumors in your body.
This is a single arm, open-label Phase I/II study to evaluate the clinical activity of the novel inhibitor of Poly(ADP-ribose) polymerase (PARP), ABT-888 with modified FOLFOX-6 (5-Fluorouracil plus oxaliplatin) in patients with metastatic pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: ABT-888 40mg (Cohort 1) | Experimental | ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 60 mg (Cohort 2) | Experimental | ABT-888 orally at 60mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 80 mg (Cohort 3) | Experimental | ABT-888 orally at 80mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 100 mg (Cohort 4) | Experimental | ABT-888 orally at 100mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-888 | Drug | ABT-888 in escalating doses twice a day for Days 1-7 of each 14-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Dose Limiting Toxicities | Protocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study. | 28 days |
| Phase II: Objective Response Rate (ORR) | Number of Participants in Phase II with a Complete response and Partial response as determined by RECIST 1.1. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | DCR is defined as the number of patients with a complete response, partial response, or stable disease at 6 months per Recist 1.1. | 6 months |
| Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Histologically proven pancreatic adenocarcinoma with measurable disease
A known BRCA-associate genetic mutation OR family history suggesting of a breast or ovarian cancer syndrome, as defined by one or more of the following:
Personal or known family history of a deleterious (or indeterminate) mutation in the BRCA1, BRCA2, PALBB2, or one of the FANC genes.
Personal history of breast cancer and one or more of the following:
Personal history of epithelial ovarian cancer
Personal history of male breast cancer
Personal history of pancreatic cancer and ≥2 1st, 2nd, or 3rd degree relatives with breast, epitherlial ovarian, pancreatic, or aggressive prostate cancer (Gleason score ≥7) at any age
Age >= 18 years
ECOG performance status 0-2
Subjects with no brain metastases or a history of previously treated brain metastases who have been treated with surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of intercranial disease and have not had treatment with steroids within 1 week of study enrollment.
Subjects may have received any number of prior therapies except prior therapy with a PARP inhibitor
At least 14 days must have passed since all prior anti-cancer therapy
At least 28 days must have passed since any prior antibody-based therapies
At least 28 days must have passed since any prior investigational agent
All patients must have completely recovered from all transient side effects related to prior therapies and any side effects that are expected to be more durable or permanent must have resolved to Grade 1
Adequate hepatic, bone marrow and renal function
Partial thromboplastin time must be </= 2 X upper limit of institution's normal range and INR < 2. Subjects on an anticoagulant must have a PTT </= 5 X upper limit of institution's normal range and INR < 5.
Life expectancy > 12 weeks
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment
Subject must be capable of understanding and complying with parameters as outlined in protocol and able to sign and date the informed consent form
Patients must have fully recovered from all effects of surgery.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Pishvaian, MD PhD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: ABT-888 40mg (Cohort 1) | ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IVon Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hoursDays 1-3 |
| FG001 | Phase 1: ABT-888 60 mg (Cohort 2) | ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle. mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG002 | Phase 1: ABT-888 80 mg (Cohort 3) | ABT-888 orally at 80 mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG003 | Phase 1: ABT-888 100 mg (Cohort 4) | ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG004 | Phase 1: ABT-888 150 mg (Cohort 5) | ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG005 | Phase 1: ABT-888 200 mg (Cohort 6) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG006 | Phase 1: ABT-888 250 mg (Cohort 7) | ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG007 | Phase 1: ABT-888 300 mg (Cohort 8) | ABT-888 orally at 300mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| FG008 | Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: ABT-888 40mg (Cohort 1) | ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase 1: Number of Dose Limiting Toxicities | Protocol defined events that are definitely, possibly or probably related to one or both agents and have occurred in the first cycle of therapy. Applies only to patients in the Phase I portion of the study. | Posted | Number | Dose Limiting Toxicities | 28 days |
|
From the time of study drug administration until 30 days following discontinuation of study drug administration, up to 10 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: ABT-888 40mg (Cohort 1) | ABT-888 orally at 40mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6 with 5-FU bolus mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders - Other, specify | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | complete heart block |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Weinberg, MD | Lombardi Comprehensive Cancer Center | 202-444-2223 | baw12@gunet.georgetown.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2018 | Dec 20, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C521013 | veliparib |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
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| Phase 1: ABT-888 150 mg (Cohort 5) | Experimental | ABT-888 orally at 150mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 200 mg (Cohort 6) | Experimental | ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 250 mg (Cohort 7) | Experimental | ABT-888 orally at 250mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 1: ABT-888 300 mg (Cohort 8) | Experimental | ABT-888 orally at 300mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
| Phase 2: ABT-888 at Recommended phase 2 dose (200mg) | Experimental | ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
|
| mFOLFOX-6 | Drug | Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
|
|
PFS is defined as the number of days from enrollment to progression or death, whichever occurred first.
| up to 114 months |
| Overall Survival | The number of days from enrollment until death or last contact. Patients who were alive at the time of analysis were censored at their last contact. | up to 114 months |
| Adverse Event |
|
| Death |
|
| Withdrawal by Subject |
|
| Shifted |
|
| Phase 1: ABT-888 60 mg (Cohort 2) |
ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG002 | Phase 1: ABT-888 80 mg (Cohort 3) | ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG003 | Phase 1: ABT-888 100 mg (Cohort 4) | ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG004 | Phase 1: ABT-888 150 mg (Cohort 5) | ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG005 | Phase 1: ABT-888 200 mg (Cohort 6) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG006 | Phase 1: ABT-888 250 mg (Cohort 7) | ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG007 | Phase 2: ABT-888 atRecommended Phase 2 Dose (200mg) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| BG008 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Phase 1: ABT-888 80 mg (Cohort 3) | ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| OG003 | Phase 1: ABT-888 100 mg (Cohort 4) | ABT-888 orally at 100mg twice a day for Days 1-7of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 |
| OG004 | Phase 1: ABT-888 150 mg (Cohort 5) | ABT-888 orally at 150mg twice a day for Days 1-7of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| OG005 | Phase 1: ABT-888 200 mg (Cohort 6) | ABT-888 orally at 200mg with mFOLFOX-6 twice a day for Days 1-7of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
| OG006 | Phase 1: ABT-888 250 mg (Cohort 7) | ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusionover 46 hours Days 1-3 |
|
|
| Primary | Phase II: Objective Response Rate (ORR) | Number of Participants in Phase II with a Complete response and Partial response as determined by RECIST 1.1. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR is defined as the number of patients with a complete response, partial response, or stable disease at 6 months per Recist 1.1. | response-evaluable patients | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS is defined as the number of days from enrollment to progression or death, whichever occurred first. | Posted | Median | Full Range | days | up to 114 months |
|
|
|
| Secondary | Overall Survival | The number of days from enrollment until death or last contact. Patients who were alive at the time of analysis were censored at their last contact. | Posted | Median | Full Range | days | up to 114 months |
|
|
|
| 6 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | Phase 1: ABT-888 60 mg (Cohort 2) | ABT-888 orally at 60mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 3 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase 1: ABT-888 80 mg (Cohort 3) | ABT-888 orally at 80mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 3 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Phase 1: ABT-888 100 mg (Cohort 4) | ABT-888 orally at 100mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 3 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Phase 1: ABT-888 150 mg (Cohort 5) | ABT-888 orally at 150mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 3 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase 1: ABT-888 200 mg (Cohort 6) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 7 | 7 | 0 | 7 | 6 | 6 |
| EG006 | Phase 1: ABT-888 250 mg (Cohort 7) | ABT-888 orally at 250mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 6 | 6 | 3 | 6 | 4 | 7 |
| EG007 | Phase 2: ABT-888 at Recommended Phase 2 Dose (200mg) | ABT-888 orally at 200mg twice a day for Days 1-7 of each 14-day cycle with mFOLFOX-6: Oxaliplatin 85 mg/m2 IV on Day 1; Leucovorin 400 mg/m2 IV on Day 1; 5-FU 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3 | 30 | 33 | 12 | 33 | 32 | 33 |
|
| Gastric perforation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Pneumonia |
|
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Gram Negative bacteremia |
|
| Sepsis | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Investigations - Other, specify | Investigations | CTCAE (4.0) | Systematic Assessment | Liver enzymes elevated |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Facial muscle weakness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroparesis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |