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The purpose of this study is to determine if the combination of paclitaxel protein bound, gemcitabine, cisplatin, paricalcitol are effective in individuals with resectable and unresectable pancreatic cancer.
Neoadjuvant therapy has become the consensus treatment for individuals with locally advanced unresectable disease and borderline resectable disease. Typical regimens utilize those that are used in the metastatic setting for pancreatic cancer, such as FOLFIRINOX (5-FU, Leucovorin, Irinotecan, and Oxaliplatin) and paclitaxel protein bound plus Gemcitabine. Currently, the recommendation of utilizing neoadjuvant therapy for potentially resectable pancreatic cancer has been met with controversy. However a recent study published an analysis of individuals with potentially resectable pancreatic cancer and showed a median overall survival of 31.5 months with 44.9 months for the 60 individuals who underwent neoadjuvant therapy and resection compared to 8.1 months for the 9 patients who were not resected. Another study examined the use of nab-paclitaxel, gemcitabine, capecitabine, and cisplatin (PAXG regimen) in individuals with unresectable or borderline resectable pancreatic cancer patients. A partial response was observed in 67% of the patients along with progression-free survival at 6 months being 96%. Furthermore, a recent study examining stage I or stage II pancreas cancer patients who received either neoadjuvant therapy followed by resection or those who received upfront resection was reported. In those receiving neoadjuvant therapy, overall survival was 26 months compared to 21 months. Neoadjuvant, as opposed to adjuvant therapy potentially increases the amount of exposure of drug to the tumor. It allows for the completion of therapy prior to surgery to prevent patient drop-out due to perioperative complication. Neoadjuvant therapy also acts as a selection tool for optimal surgical candidates by identifying aggressive tumor biology prior to surgery and therefore selecting out those who will not benefit from resection. Radiation therapy may be also employed in the neoadjuvant setting as a means to help with local control and survival in individuals without micrometastatic disease.
The combination of nab-paclitaxel (now called paclitaxel protein bound) and gemcitabine had a high response and survival in the phase I and II study in advanced pancreatic cancer. In this phase I study with expansion at the phase II dose, 67 pts were accrued. The phase II dose was determined to be weekly nab-paclitaxel 125 mg/m2 with gemcitabine 1000 mg/m2. Therapy was well tolerated at the phase II dose. For all patients (n=67), the median time for progression-free survival (PFS) was 7.1 months (95%CI, 5.7 to 8.0 months), and the median time for overall survival (OS) was 10.3 months (95% CI, 8.4 to 13.6 months). For patients at the recommended dose of 125 mg/m2 nab-paclitaxel, the median PFS was 7.9 months (95% CI, 5.8 to 11.0 months), and the median OS time was 12.2 months (95% CI, 8.9 to 17.9 months). Additionally, the 1-year survival is reported at 48% at the maximum tolerated dose (MTD), and the overall response rate (ORR) was 46% for all patients (n=67). The combination of nab-paclitaxel and gemcitabine was generally well tolerated and had substantial antitumor activity in patients with pancreatic cancer, enough to warrant a phase III clinical trial.
In the phase III (MPACT study, n=861) patients were randomly assigned to nab-paclitaxel plus gemcitabine (431 patients) or gemcitabine (430). The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group (P<0.001). The one year survival rate was 35% in the nab-paclitaxel-gemcitabine group versus 22% in the gemcitabine group, and 9% versus 4% at 2 years. The median PFS was 5.5 months in the nab-paclitaxel-gemcitabine group, as compared with 3.7 months in the gemcitabine group (P<0.001); the response rate according to independent review was 23% versus 7% in the two groups (P<0.001). Adverse events were tolerable with grade > 3 events of neutropenia (38% in the nab-paclitaxel-gemcitabine group vs. 27% in the gemcitabine group), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%) and febrile neutropenia (3% versus 1%). Based on the results of this study, nab-paclitaxel plus gemcitabine is a FDA approved regimen for pancreatic cancer.
Building on the design and mechanisms of action of the nab-paclitaxel and gemcitabine combination, a prior protocol introduced a third cytotoxic agent cisplatin, was added to this doublet. The rationale for adding cisplatin to nab-paclitaxel and gemcitabine was that in a study of 1,029 patients whose pancreatic cancer tumors were sent for molecular profiling, 57% of these tumors were negative for ERCC1, indicating sensitivity to a platinum anti-tumor agent. In addition to the above, in our whole genome/transcriptome sequencing analysis, we found that abnormal repair pathways were a feature of all of the pancreatic cancers that were sequenced. Cisplatin prevents cellular DNA repair by binding to and causing crosslinking of DNA, triggering apoptosis. Cisplatin has been used in other combination regimens to treat patients with PDA. For example, the cisplatin, epirubicin, 5-fluorouracil and gemcitabine (PEFG) regimen had an acceptable toxicity profile and was associated with a 24% partial response rate, 5 month progression-free survival (PFS) and 8.3 month overall survival as second line therapy.
Prior to 2015, there were no documented reports of the combination of cisplatin with paclitaxel protein bound and gemcitabine in the treatment of any human cancer. However, cisplatin had been combined with paclitaxel and gemcitabine in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) patients and had shown substantial antitumor activity with an acceptable safety profile. In that phase I-II study of 65 patients with advanced NSCLC, the overall response rate was 57%. The aforementioned neoadjuvant study led by Reni also utilized cisplatin with albumin bound paclitaxel along with gemcitabine and capecitabine.
More recently there has been even more compelling science indicating that one should consider DNA repair as an Achilles heel in pancreatic cancer. A team led by Nurse Practitioner Gayle Jameson recently reported on the phase Ib/II trial of the combination of paclitaxel protein-bound plus gemcitabine plus cisplatin. In 24 evaluable patients with stage IV pancreatic cancer they reported a response rate of 71% (Complete Response (CR) + Partial Response (PR)) along with a 88% disease control rate (CR + PR+ Stable Disease (SD) at 9 weeks). Utilizing this highly active therapy in the neoadjuvant setting may lead to further improvement in overall survival and progression free survival in patients with pancreatic cancer.
Most recently the spectacular work of researchers has awakened the world of pancreatic cancer research to the possibility that Vitamin D could be a substantial player in normalizing the tumor microenvironment from an immunologically friendly (to the tumor) one to an immunologically hostile one (e.g. decreased IL6, decreased CXCL12 etc.). In addition, the vitamin D analog decreased production of collagen, decreased Myeloid Derived Suppressor cells (MDSCs) and decreased regulating T cells. In an ongoing neoadjuvant trial utilizing gemcitabine and paclitaxel protein bound with paricalcitol compared to gemcitabine and paclitaxel protein bound, a modulation of the tumor microenvironment has been seen including greater infiltration of CD3 positive lymphocytes. Therefore, a trial utilizing gemcitabine, paclitaxel protein bound, cisplatin and paricalcitol may yield promising results in the neoadjuvant setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Resectable | Experimental | Participants with resectable pancreatic cancer are assigned to Cohort A (see Protocol for definitions). Participants are offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. Participants whose CA19-9 levels normalize during the above neoadjuvant therapy will be re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
|
| Cohort B: Borderline Resectable/Locally Advanced (Unresectable) | Experimental | Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer are assigned to Cohort B (see Protocol for definitions). Participants are offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. Participants whose CA19-9 levels normalize during the above neoadjuvant therapy will be re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel Protein Bound (Abraxane) | Drug | Participants will be treated with the regimen prior to having surgery. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization. If CA19-9 is normalized, then participant will be scheduled for surgery and moved to standard of care. If CA19-9 is not normalized then participants will complete another 3 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| CA 19-9 Normalization | Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected after every treatment cycle (approximately 3 weeks/cycle); CA 19-9 normalization after 3 or more treatment cycles was measured. | From enrollment to the end of treatment, up to 26 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Resectability Rate (R0) | The percentage of participants whose tumors could be completely removed by surgery with no cancer cells left at margins (R0). | From enrollment to the end of treatment, up to 26 weeks. |
| Pathologic Complete Response Rate (pCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score | The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain severity was assessed with a scale range of 0-10, 0=no pain, 10=worst imaginable. Multiple question results were combined into a single pain severity score per patient on the 0-10 scale range. |
Inclusion Criteria:
Patient has histologically or cytologically confirmed resectable, borderline resectable, or locally advanced (unresectable) PDAC (based upon Tempero et al 2016)
Age ≥ 18 years.
If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (≥β-hCG) documented within 72 hours of the first administration of study drug
If sexually active, the patient and partner must agree to use contraception considered adequate and appropriate by the Investigator
Patient must have received no prior chemotherapy or radiation therapy for PDAC
Patients must have normal organ and marrow function as defined below:
Patient has acceptable coagulation status as indicated by an INR ≤ 1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
Karnofsky Performance Status (KPS) of ≥70%.
Have an elevated CA 19-9
Exclusion Criteria:
Patient will be excluded from this study if any of the following criteria apply: Evidence of metastatic disease. No metastatic disease defined as any one or more of the following:
Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Known infection with HIV, hepatitis B, or hepatitis C.
Has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.
History of allergy or hypersensitivity to the study drugs.
Serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.
Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
Patient is unwilling or unable to comply with study procedures.
Patient is enrolled in any other therapeutic clinical protocol or investigational trial.
Patient with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies.
Use of non-FDA approved cannabinoids are prohibited. Total daily usage of up to 40 mg per day of marinol is acceptable.
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| Name | Affiliation | Role |
|---|---|---|
| Erkut Borazanci, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42268676 | Derived | Viniotis AF, Jameson GS, Wertheim BC, Roe DJ, Lee K, Tsai FY, Gordon MS, Sharma S, Guarnieri CM, Snyder CE, Thosani AJ, Amini A, Sckolnik SE, Garrick JM, Korn RL, Rahmanuddin S, Evans RM, Downes M, Truitt M, Von Hoff DD, Borazanci EH. A phase II clinical trial of albumin-bound paclitaxel, cisplatin, gemcitabine (NABPLAGEM) and paricalcitol as neoadjuvant therapy in pancreatic cancer. Oncologist. 2026 Jun 10:oyag232. doi: 10.1093/oncolo/oyag232. Online ahead of print. |
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IPD will not be shared with outside researchers.
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n=8 participants did not meet inclusion/exclusion criteria for the following reasons: High bilirubin (n=2); Metastatic disease (n=3); Normal CA 19-9 (n=1); Normalized CA 19-9 (n=1); Withdrew consent (n=1).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Resectable | Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
| FG001 | Cohort B: Borderline Resectable/Locally Advanced (Unresectable) | Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Resectable | Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Resectability Rate (R0) | The percentage of participants whose tumors could be completely removed by surgery with no cancer cells left at margins (R0). | Only a subset of participants underwent tumor surgical resection. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to the end of treatment, up to 26 weeks. |
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From enrollment until end of treatment, up to 26 weeks.
Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
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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 | Cohort A: Resectable | Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
The COVID-19 pandemic imposed restrictions at the study site and impacted study conduct. Accordingly, Investigators allowed flexibility in study visit schedules that were captured as protocol deviations. Additional limitations: (1) a suboptimal EDC design which affected data collection; (2) incomplete monitoring/delays in SAE reconciliation requiring corrective actions. These factors collectively contributed to missed study procedures and delays in data monitoring/finalization of study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erkut Borazanci, MD | HonorHealth Research Institute | 480-583-7120 | eborazanci@honorhealth.com |
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| 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 | Mar 25, 2020 | Jan 14, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| C084656 | paricalcitol |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
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There will be two treatment groups: those who are deemed resectable and those that are deemed borderline resectable and with locally advanced pancreas cancer.
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No masking
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Participants received a CT/MRI scan after completing treatment cycles 3, 6, 9 to evaluate disease status using same imaging method as Baseline. RECIST 1.1 criteria were used to evaluate response. A confirmatory PET scan may have been ordered to confirm complete response.
| From enrollment to end of treatment, up to 26 weeks. |
| Radiological Response - All Responses | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; >30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; >20% increase in tumor size or new lesions). | From enrollment to the end of treatment, up to 26 weeks. |
| Radiological Response - Complete Response (CR) or Partial Response (PR) | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; >30% decrease in tumor size). | From enrollment to the end of treatment, up to 26 weeks. |
| Overall Survival | Participants were contacted by telephone every 12 weeks to monitor survival until date of death. | every 12 weeks after study completion |
| From enrollment to end of study, up to 26 weeks. |
| Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score | The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain interference was assessed with a scale range of 0-10, 0=does not interfere, 10=completely interferes. Multiple question results were combined into a single pain interference score per patient on the 0-10 scale range. | From enrollment through end of study, up to 26 weeks. |
| Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Core symptom severity within the last 24 hours was assessed with a scale range of 0-10, 0=not present, 10=worst imaginable. The reported severity of multiple symptoms was combined into a single overall symptom severity score for each patient on the 0-10 scale range. | From enrollment to end of study, up to 26 weeks. |
| Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. The GI module asks specific questions related to GI symptoms and asks users to rank the severity of symptoms using a 0-10 scale, 0=not present, 10=worst imaginable. The reported severity of multiple GI symptoms was combined into a single GI module score for each patient on the 0-10 scale range. | From enrollment to end of study, up to 26 weeks. |
| Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Symptom interference with daily life activities within the last 24 hours was measured using a 0-10 scale, 0=does not interfere, 10=interferes completely. The reported interference for multiple daily activities was combined into a single symptom interference score for each patient on the 0-10 scale range. | From enrollment to end of study, up to 26 weeks. |
| BG001 | Cohort B: Borderline Resectable/Locally Advanced (Unresectable) | Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Karnofsky Performance Status (KPS) | The Karnofsky Performance Scale (KPS) ranges from 0-100% and allows patients to be graded and classified by functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. Lower KPS is associated with the worse survival. (0 = unable to care for self, requires equivalent of institutional or hospital care, disease may be progressing; 100 = able to carry on normal activity and to work, no special care needed). | Count of Participants | Participants |
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| Primary Tumor Site, Pancreas | Count of Participants | Participants |
|
| Pancreatic Cancer Stage | Pancreatic cancer stage measured according to the American Joint Committee on Cancer (AJCC) numerical system. Lower stage is associated with earlier disease. Cancer confined to the pancreas for Stage IA (≤ 2 cm lesion), Stage IB (2 - 4 cm lesion), and Stage IIA (>4 cm lesion) with no lymph node or distant site spread. Cancer spread to ≤ 3 nearby lymph nodes for Stage IIB but not distant site. Cancer spread to ≥ 4 nearby lymph nodes OR growing outside pancreas into nearby major blood vessels for Stage III but not distant site. Cancer spread to distant sites for Stage IV. | Count of Participants | Participants |
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| CA 19-9 | CA 19-9 (Cancer Antigen 19-9) is a tumor marker used to monitor pancreatic cancer progression. | Median | Full Range | U/mL |
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| OG001 | Cohort B: Borderline Resectable/Locally Advanced (Unresectable) | Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. |
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| Secondary | Pathologic Complete Response Rate (pCR) | Participants received a CT/MRI scan after completing treatment cycles 3, 6, 9 to evaluate disease status using same imaging method as Baseline. RECIST 1.1 criteria were used to evaluate response. A confirmatory PET scan may have been ordered to confirm complete response. | Row "Participants Who Underwent Surgery" highlights pCR for the subset of patients who underwent surgical resection of their primary tumor. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to end of treatment, up to 26 weeks. |
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| Secondary | Radiological Response - All Responses | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; >30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; >20% increase in tumor size or new lesions). | Radiologic response was not available for n=4 participants. | Posted | Count of Participants | Participants | From enrollment to the end of treatment, up to 26 weeks. |
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| Secondary | Radiological Response - Complete Response (CR) or Partial Response (PR) | Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; >30% decrease in tumor size). | Radiological response was not available for n=4 participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to the end of treatment, up to 26 weeks. |
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| Other Pre-specified | Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score | The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain severity was assessed with a scale range of 0-10, 0=no pain, 10=worst imaginable. Multiple question results were combined into a single pain severity score per patient on the 0-10 scale range. | Posted | Median | Inter-Quartile Range | BPI Pain Severity Score | From enrollment to end of study, up to 26 weeks. |
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| Other Pre-specified | Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score | The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain interference was assessed with a scale range of 0-10, 0=does not interfere, 10=completely interferes. Multiple question results were combined into a single pain interference score per patient on the 0-10 scale range. | Posted | Median | Inter-Quartile Range | BPI Pain Interference Score | From enrollment through end of study, up to 26 weeks. |
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| Other Pre-specified | Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Core symptom severity within the last 24 hours was assessed with a scale range of 0-10, 0=not present, 10=worst imaginable. The reported severity of multiple symptoms was combined into a single overall symptom severity score for each patient on the 0-10 scale range. | Posted | Median | Inter-Quartile Range | MDASI-GI Symptom Severity Score | From enrollment to end of study, up to 26 weeks. |
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| Other Pre-specified | Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. The GI module asks specific questions related to GI symptoms and asks users to rank the severity of symptoms using a 0-10 scale, 0=not present, 10=worst imaginable. The reported severity of multiple GI symptoms was combined into a single GI module score for each patient on the 0-10 scale range. | Posted | Median | Inter-Quartile Range | MDASI-GI GI Module Score | From enrollment to end of study, up to 26 weeks. |
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| Other Pre-specified | Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score | The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Symptom interference with daily life activities within the last 24 hours was measured using a 0-10 scale, 0=does not interfere, 10=interferes completely. The reported interference for multiple daily activities was combined into a single symptom interference score for each patient on the 0-10 scale range. | Posted | Median | Inter-Quartile Range | MDASI-GI Symptom Interference Score | From enrollment to end of study, up to 26 weeks. |
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| Secondary | Overall Survival | Participants were contacted by telephone every 12 weeks to monitor survival until date of death. | Posted | Median | 95% Confidence Interval | Months | every 12 weeks after study completion |
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| Primary | CA 19-9 Normalization | Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected after every treatment cycle (approximately 3 weeks/cycle); CA 19-9 normalization after 3 or more treatment cycles was measured. | Posted | Number | 95% Confidence Interval | Percentage of participants | From enrollment to the end of treatment, up to 26 weeks. |
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| 3 |
| 10 |
| 3 |
| 10 |
| 10 |
| 10 |
| EG001 | Cohort B: Borderline Resectable/Locally Advanced (Unresectable) | Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and repeated every 21 days; Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible. | 14 | 22 | 11 | 22 | 22 | 22 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood Antidiuretic Hormone Abnormal | Investigations | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Other - Biliary Obstruction | Hepatobiliary disorders | Systematic Assessment |
|
| Biliary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Duodenal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatic Necrosis | Gastrointestinal disorders | Systematic Assessment |
|
| Appendicitis Perforated | Infections and infestations | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Other - Cellulitis | Infections and infestations | Systematic Assessment |
|
| Biliary Fistula | Hepatobiliary disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Flashing Lights | Eye disorders | Systematic Assessment |
|
| Floaters | Eye disorders | Systematic Assessment |
|
| Other - Vision Changes | Eye disorders | Systematic Assessment |
|
| Other - Visual Disturbance | Eye disorders | Systematic Assessment |
|
| Hearing Impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Non-Cardiac Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
|
| Mucositis Oral | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
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| Other - Early Satiety | Gastrointestinal disorders | Systematic Assessment |
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| Rectal Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Edema Limbs | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Flu Like Symptoms | General disorders | Systematic Assessment |
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| Gait Disturbance | General disorders | Systematic Assessment |
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| Infusion Related Reaction | General disorders | Systematic Assessment |
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| Other - Generalized Edema | General disorders | Systematic Assessment |
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| Abdominal Infection | Infections and infestations | Systematic Assessment |
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| Lip Infection | Infections and infestations | Systematic Assessment |
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| Other - Oral Candidiasis | Infections and infestations | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
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| Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
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| Creatinine Increased | Investigations | Systematic Assessment |
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| Neutrophil Count Decreased | Investigations | Systematic Assessment |
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| Platelet Count Decreased | Investigations | Systematic Assessment |
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| Weight Loss | Investigations | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Amnesia | Nervous system disorders | Systematic Assessment |
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| Cognitive Disturbance | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Other - Nocturia | Renal and urinary disorders | Systematic Assessment |
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| Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other - Rales | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Postnasal Drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythroderma | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nail Discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Crusted Lesion Lower Lip | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Peri Anal Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Other - Petechiae | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Chest Pain - Cardiac | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
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| Ventricular Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Adrenal Insufficiency | Endocrine disorders | Systematic Assessment |
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| Other - Hypogonadism | Endocrine disorders | Systematic Assessment |
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| Other - Testosterone Decreased | Endocrine disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
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| Anal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Duodenal Ulcer | Gastrointestinal disorders | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
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| Oral Hemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Other - Anal Fissure | Gastrointestinal disorders | Systematic Assessment |
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| Other - Gingival Bleeding | Gastrointestinal disorders | Systematic Assessment |
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| Other - Melena | Gastrointestinal disorders | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Neck Edema | General disorders | Systematic Assessment |
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| Other - Catheter Site Pain | General disorders | Systematic Assessment |
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| Other - Heart Beating Fast Sensation | General disorders | Systematic Assessment |
|
| Other - Sweating | General disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
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| Allergic Reaction | Immune system disorders | Systematic Assessment |
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| Device Related Infection | Infections and infestations | Systematic Assessment |
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| Lung Infection | Infections and infestations | Systematic Assessment |
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| Other - COVID-19 | Infections and infestations | Systematic Assessment |
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| Other - Cellulitis | Infections and infestations | Systematic Assessment |
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| Other - Lower Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Other - Skin Infection Fungal | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Other - Skin Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Other - Glucosuria | Investigations | Systematic Assessment |
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| Other - Hemoglobin A1c increased | Investigations | Systematic Assessment |
|
| Pancreatic Enzymes Decreased | Investigations | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Other - Vitamin B12 decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Other - Vitamin D decreased | Metabolism and nutrition disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other - Muscle Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other - Pain in lower ribs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other - Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Presyncope | Nervous system disorders | Systematic Assessment |
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| Stroke | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Hallucinations | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Restlessness | Psychiatric disorders | Systematic Assessment |
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| Other - Urinary Hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Genital Edema | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Erythema Multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Cold Sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Cutaneous Candida | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Mole Changes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Pimple | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Ringworm Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other - Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Periorbital Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot Flashes | Vascular disorders | Systematic Assessment |
|
| Other - Carotid Stenosis | Vascular disorders | Systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| Participants Who Underwent Surgery |
|
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This analysis tested whether Pathologic Complete Response Rate (pCR) significantly varied by treatment group (Cohort A vs Cohort B) among the subset of participants who went on to surgery. |
| Chi-squared |
| 0.178 |
| Other |
Pathologic Complete Response Rate (pCR) was determined to vary significantly by treatment group if test p-value ≤0.05. |
| Stable Disease (SD) |
|
| Change Between Baseline and EOT |
|
| Change Between Baseline and EOT |
|
| Change Between Baseline and EOT |
|
| Change Between Baseline and EOT |
|
| Change Between Baseline and EOT |
|
This analysis tested whether overall survival significantly varied by treatment group (Cohort A vs Cohort B).
| Log Rank |
| 0.317 |
| Other |
Overall survival was determined to vary significantly by treatment group if test p-value ≤0.05. |
| Major responder (> 89%) |
|
| Normalized (< 35 U/mL) |
|
This analysis tested whether CA 19-9 normalization varied by treatment group (Cohort A vs Cohort B).
| Chi-squared |
| 0.290 |
| Other |
CA 19-9 normalization was determined to vary significantly by treatment group if test p-value ≤0.05. |