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This study is designed to compare the treatment effect of PEGPH20 combined with nab-paclitaxel (NAB) and gemcitabine (GEM) [PAG] to NAB and GEM [AG] in participants with Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).
The study will have 2 run-in phases, one for each formulation of PEGPH20 (original and new formulations), and a Phase 2 portion. The 2 run-in phases will evaluate the safety and tolerability of the PAG treatment using the original and new succinic acid PEGPH20 formulation, respectively, compared with AG treatment. Phase 2 will have 2 stages due to a partial clinical hold that occurred from April through July 2014. The participants will be randomized in 3:1 for the run-in phases. The first stage will randomize participants in a 1:1 ratio. The second stage will randomize participants in a 2:1 ratio (PAG:AG).
This is an open-label study. To minimize bias to the progression-free survival endpoint, disease progression will be based on the assessment of the Central Imaging Reader (CIR). Determination of clinical progression by the Investigator without corresponding CIR confirmation will be documented with the relevant signs and symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Experimental | Participants will receive 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m^2) NAB and 1000 mg/m^2 GEM as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 will be administered alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15 and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1 8 and 15. NAB+GEM will be given 2 to 4 hours after PEGPH20 dose. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior and 8 to 12 hours after completion of each PEGPH20 infusion. |
|
| Run-in Phase - AG: Nab-paclitaxel + Gemcitabine | Active Comparator | Participants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM, as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
| Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Experimental | Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and Day 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGPH20 | Drug | PEGPH20 will be administered as per the dose and schedule specified in the respective arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method. | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
| Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study | TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'. | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS in Relation to Tumor Hyaluronan (HA) Levels | PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VP, Clinical Development | Halozyme Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 35213 | United States | ||
| University of South Alabama Mitchell Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29232172 | Result | Hingorani SR, Zheng L, Bullock AJ, Seery TE, Harris WP, Sigal DS, Braiteh F, Ritch PS, Zalupski MM, Bahary N, Oberstein PE, Wang-Gillam A, Wu W, Chondros D, Jiang P, Khelifa S, Pu J, Aldrich C, Hendifar AE. HALO 202: Randomized Phase II Study of PEGPH20 Plus Nab-Paclitaxel/Gemcitabine Versus Nab-Paclitaxel/Gemcitabine in Patients With Untreated, Metastatic Pancreatic Ductal Adenocarcinoma. J Clin Oncol. 2018 Feb 1;36(4):359-366. doi: 10.1200/JCO.2017.74.9564. Epub 2017 Dec 12. | |
| 33478521 |
| Label | URL |
|---|---|
| Reflects interim analysis conducted on mature data when 95% of participants had discontinued from the study. | View source |
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Study was on partial clinical hold from April to July 2014 due to higher incidence of thromboembolic events (TE) in PAG arm participants. Study enrollment (Stage 2) was reopened in June 2014 after excluding participants with high-risk of TE and adding enoxanparin prophylasis. Participants of PAG and AG arm both received AG during clinical hold.
Study had 2 run-in phases (for evaluating safety and tolerability of PAG [PEGPH20 + Nab-paclitaxel {NAB} + Gemcitabine {GEM}] treatment), one for each formulation of PEGPH20 (original and new formulations [injectable solution containing 3.5 milligrams/milliliter {mg/mL} and 0.3 mg/mL PEGPH20, respectively]), and a Phase 2 (Stage 1 and 2) portion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Run-in Phase - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Participants received 3.0 micrograms/kilogram (mcg/kg) PEGPH20 with 125 milligrams/square meter (mg/m^2) nab-paclitaxel (NAB) and 1000 mg/m^2 gemcitabine (GEM) as intravenous (IV) infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Phase (Maximum Exposure:295 Days) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2018 | Jun 11, 2020 |
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|
| Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine | Active Comparator | Participants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
| Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Experimental | Participants will receive 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 will be given alone on Days 1 and 4 and NAB+GEM will be given on Day 2 at approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 will be given twice/week on Days 8, 11, 15, and 18 and NAB+GEM will be given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM will be given once/week on Days 1, 8, and 15. NAB+GEM will be given 2 to 4 hours after dose of PEGPH20. Each cycle will be of 4-weeks with Week 4 of every cycle as a rest week (no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given subcutaneously (SC). |
|
| Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine | Active Comparator | Participants will receive 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle will be of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment will be given). Treatment will continue until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg will be given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day will be given SC. |
|
| Nab-paclitaxel | Drug | Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms. |
|
|
| Gemcitabine | Drug | Gemcitabine will be administered as per the dose and schedule specified in the respective arms. |
|
|
| Dexamethasone | Drug | Dexamethasone will be administered as per the dose and schedule specified in the respective arms. |
|
| Enoxaparin | Drug | Enoxaparin will be administered as per the dose and schedule specified in the respective arms. |
|
| From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
| Objective Response Rate (ORR): Percentage of Participants With Objective Response | ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
| Overall Survival | Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date. | From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
| Percentage of Participants With AEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG) |
| Maximum Observed Plasma Concentration (Cmax) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
| Time to Reach Cmax (Tmax) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
| Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States |
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | United States |
| Arizona Oncology Associates, PC | Tucson | Arizona | 85704 | United States |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | United States |
| Providence St Joseph Medical Center | Burbank | California | 91505 | United States |
| Scripps Cancer Center | La Jolla | California | 92037 | United States |
| UCSD - Moore's Cancer Center | La Jolla | California | 92093 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California Medical Center | Orange | California | 92868 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| Saint Helena Hospital | St. Helena | California | 94574 | United States |
| The Oncology Institute of Hope and Innovation | Whittier | California | 90603 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami, Sylvester comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| H. Lee Moffit Cancer Center | Tampa | Florida | 33612 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30318 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Norton Cancer Institute - Norton HealthCare Pavilion | Louisville | Kentucky | 40202 | United States |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21231 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| University of Mass Medical School | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Virginia Piper Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| Unniversity of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| St. Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| North Shore Long Island Jewish Health System | Lake Success | New York | 11042 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Texas Oncology - Baylor | Dallas | Texas | 75246 | United States |
| Cancer Care Centers of South Texas | New Braunfels | Texas | 78130 | United States |
| Texas Oncology | Tyler | Texas | 75702 | United States |
| Columbia Basin Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| NorthWest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| University of Wisconsin Hospitals and Clinics | Madison | Wisconsin | 53792 | United States |
| Froedtert Hospital, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Derived |
| Wang S, Bager CL, Karsdal MA, Chondros D, Taverna D, Willumsen N. Blood-based extracellular matrix biomarkers as predictors of survival in patients with metastatic pancreatic ductal adenocarcinoma receiving pegvorhyaluronidase alfa. J Transl Med. 2021 Jan 21;19(1):39. doi: 10.1186/s12967-021-02701-z. |
| FG001 | Run-in Phase - AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
| FG002 | Phase 2: Stage 1 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were administered once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion. |
| FG003 | Phase 2: Stage 1 - AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
| FG004 | Phase 2: Stage 2 - PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after dose of PEGPH20. Each cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to beginning and 8 to 12 hours after completion of each PEGPH20 infusion. Enoxaparin 40 mg/day or 1 mg/kg/day was given subcutaneously (SC). |
| FG005 | Phase 2: Stage 2 - AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. Enoxaparin 40 mg/day or 1 mg/kg/day was given SC. |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 (Maximum Exposure:935 Days) |
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|
Intent-to-treat (ITT) population included all participants who were randomized, including the run-in phases.
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| ID | Title | Description |
|---|---|---|
| BG000 | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion. |
| BG001 | AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) | PFS: time from randomization until first occurrence of disease progression, either by central radiologic determination (Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Radiological disease progression was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 millimeters (mm); Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using Kaplan-Meier (KM) method. | Efficacy evaluable (EE) population: all randomized participants who received at least 1 dose of any study drug, who had measurable disease at baseline, and had a post-baseline response assessment, or had clinical disease progression without a post-baseline computed tomography (CT) scan, or had died on or prior to 14 days after the last dose date. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
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| Primary | Percentage of Participants in the PAG Arm Who Experienced Any Thromboembolic (TE) Event in Stage 2 of the Study | TE events were identified by applying the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Queries (SMQ) search strategy for 3 SMQs: TE arterial, TE venous, and TE vessel type unspecified and mixed arterial and venous. TE events were considered by the Sponsor to be adverse events (AEs) of special interest. All TE events, regardless of type of event, severity, or seriousness were reported. Participants with multiple events were counted only once. A summary of serious and all other non-serious adverse events regardless of causality is located in the 'Reported AE section'. | Safety population of Stage 2 included all participants enrolled in Stage 2 of Phase 2 of study after the clinical hold, and who received at least 1 dose of study drug. This outcome was planned to be reported only for PAG arm as pre-specified in protocol. | Posted | Number | percentage of participants | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG) |
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| Secondary | PFS in Relation to Tumor Hyaluronan (HA) Levels | PFS was defined as time from randomization until first occurrence of disease progression, either by central radiologic determination (RECIST version 1.1) or by clinical progression determined by Investigator, or death during treatment period from any cause. Disease progression was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study thus far, nadir (this included baseline sum if that was the smallest on study); Sum must also demonstrate an absolute increase of at least 5 mm; Appearance of one or more new lesions; Unequivocal progression of existing non-target lesions. Surviving participants without disease progression were censored for PFS analysis at the date of last evaluable post-baseline tumor assessment. Surviving participants without any post-baseline disease assessment were censored on Day 1. PFS was estimated using KM method. PFS was measured in HA-high and HA-low participants. | Intent-to -treat (ITT) population included all participants who were randomized, including the run-in phases. 'Number analyzed'=participants with HA-high or HA-low levels. | Posted | Median | 95% Confidence Interval | months | From the date of randomization until disease progression or death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
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| Secondary | Objective Response Rate (ORR): Percentage of Participants With Objective Response | ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR) regardless of confirmation, as assessed by RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | ITT population included all participants who were randomized, including the run-in phases. | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization until last date on study treatment (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
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| Secondary | Overall Survival | Overall survival was defined as the time from randomization until death from any cause. Participants who died or were lost to follow-up by the date of analysis data cutoff were censored at their last contact date. | ITT population included all participants who were randomized, including the run-in phases. | Posted | Median | 95% Confidence Interval | months | From randomization until death from any cause (maximum exposure: 30.72 months for PAG, and 20.27 months for AG) |
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| Secondary | Percentage of Participants With AEs | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. | Safety population included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG) |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 pharmacokinetic (PK) were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
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| Secondary | Time to Reach Cmax (Tmax) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | Posted | Median | Full Range | hours | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of PEGPH20 | Samples were analyzed for PEGPH20 concentration using a validated electrochemiluminescence immunoassay. Plasma samples to assess the potential effects of NAB+GEM on PEGH20 PK were collected in the PAG treatment group in the run-in phases (Run-in Phase 1: Original PEGPH20 formulation [3.5 mg/mL], and Run-in Phase 2: New PEGPH20 formulation [0.3 mg/mL]). | PK analysis population included all participants who received any part of a dose of PEGPH20 and had measurable PEGPH20 concentrations in at least 1 sample collected for PK analysis. 'Number analyzed'=participants evaluable for this outcome at specified timepoints. | Posted | Mean | Standard Deviation | hours*ng/mL | Pre-PEGPH20 dosing and 15 minutes, 1 hour, 2 hours, and 4 hours post-PEGPH20 dosing on Days 1 and 15 of Cycle 1 |
|
From first exposure to any study drug (PEGPH20, NAB, GEM) through 30 days after end of treatment visit (maximum exposure: 30.72 months for PAG and 20.27 months for AG)
AEs were analyzed on safety population, which included all participants who received at least 1 dose of study drug. AE data was collected and reported combined for both phases per treatment arm (PAG and AG).
All-cause mortality was reported for all randomized participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PAG: PEGPH20 + Nab-paclitaxel + Gemcitabine | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion. In Cycle 1 Week 1, PEGPH20 was given alone on Days 1 and 4 and NAB+GEM was given on Day 2 at approximately 24 hours after the first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, and 18 and NAB+GEM were given once/week at 2 to 4 hours after PEGPH20 administration on Days 8 and 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, and 15. NAB+GEM were given 2 to 4 hours after the dose of PEGPH20. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning and 8 to 12 hours after the completion of each PEGPH20 infusion. | 131 | 166 | 101 | 160 | 157 | 160 |
| EG001 | AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. | 87 | 113 | 58 | 100 | 98 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Incarcerated hernia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Splenic haematoma | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vitamin K deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 20.1 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Retinal vascular disorder | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Transfusion-associated dyspnoea | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Biliary dilatation | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Development | Halozyme Therapeutics | 858-794-8889 | medinfo@halozyme.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2016 | Jun 11, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632509 | PEGPH20 |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| D003907 | Dexamethasone |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Death |
|
| Lost to Follow-up |
|
| Study Terminated by Sponsor |
|
| Other than specified |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| OG001 | AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
|
|
| OG001 | AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
|
|
Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
|
|
| OG001 | AG: Nab-paclitaxel + Gemcitabine | Participants received 125 mg/m^2 NAB and 1000 mg/m^2 GEM as an IV infusion once weekly on Days 1, 8, and 15 of each cycle. Each cycle was of 4-weeks (28 days) with Week 4 of every cycle as a rest week (that is; no treatment was given). Treatment was continued until documented disease progression or unacceptable toxicity. Dexamethasone 8 mg was given in each cycle within 2 hours prior to the beginning of each NAB infusion and 8 to 12 hours after the completion of GEM infusion. |
|
|
| OG001 | Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB, and 1000 mg/m^2 GEM, as IV infusion. In Cycle 1 Week 1, PEGPH20 was administered alone on Day 1, 4, and NAB+GEM were administered on Day 2, approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18, and NAB+GEM were given once/week, 2 to 4 hours after PEGPH20 administration on Days 8, 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each treatment cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment). Treatment was continued until disease progression or unacceptable toxicity. Dexamethasone 8 mg was administered in each treatment cycle within 2 hours prior to beginning of each PEGPH20 infusion and 8 to 12 hours after completion of each PEGPH20 infusion. |
|
|
| OG001 | Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB, and 1000 mg/m^2 GEM, as IV infusion. In Cycle 1 Week 1, PEGPH20 was administered alone on Day 1, 4, and NAB+GEM were administered on Day 2, approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18, and NAB+GEM were given once/week, 2 to 4 hours after PEGPH20 administration on Days 8, 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each treatment cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment). Treatment was continued until disease progression or unacceptable toxicity. Dexamethasone 8 mg was administered in each treatment cycle within 2 hours prior to beginning of each PEGPH20 infusion and 8 to 12 hours after completion of each PEGPH20 infusion. |
|
|
| OG001 | Run-in Phase 2- PAG: PEGPH20 (New Formulation) + NAB + GEM | Participants received 3.0 mcg/kg PEGPH20 with 125 mg/m^2 NAB, and 1000 mg/m^2 GEM, as IV infusion. In Cycle 1 Week 1, PEGPH20 was administered alone on Day 1, 4, and NAB+GEM were administered on Day 2, approximately 24 hours after first dose of PEGPH20. In Cycle 1 Weeks 2 and 3, PEGPH20 was given twice/week on Days 8, 11, 15, 18, and NAB+GEM were given once/week, 2 to 4 hours after PEGPH20 administration on Days 8, 15. In Cycle 2 onwards, PEGPH20, NAB, and GEM were given once/week on Days 1, 8, 15. NAB+GEM were given 2 to 4 hours after PEGPH20 dose. Each treatment cycle was of 4-weeks with Week 4 of every cycle as a rest week (no treatment). Treatment was continued until disease progression or unacceptable toxicity. Dexamethasone 8 mg was administered in each treatment cycle within 2 hours prior to beginning of each PEGPH20 infusion and 8 to 12 hours after completion of each PEGPH20 infusion. |
|
|