Pancreatic Adenocarcinoma Non-resectablePhase 2HALO-ISTNCT02910882
PEGPH20 Plus Gemcitabine With Radiotherapy in Patients With Localized, Unresectable Pancreatic Cancer
A Phase 2 study testing PEGylated Recombinant Human Hyaluronidase (PEGPH20), Gemcitabine and Radiation in people with Pancreatic Adenocarcinoma Non-resectable, run by Scripps Health at 1 site in United States.
Trial summary
This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- PEGylated Recombinant Human Hyaluronidase (PEGPH20), Gemcitabine and Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 31 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must satisfy all the following inclusion criteria to be enrolled in the study:
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form;
- For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study;
- Patients with previously untreated localized, unresectable histologically confirmed pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or when patients cannot have or refuse surgery);
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L;
- Platelets ≥ 100 x 109/L;
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- Hgb ≥ 9 g/dL;
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 x [Upper Limit of Normal (ULN)];
- Bilirubin ≤ 1.5 x ULN;
- GFR ≥ 30 mL/min;
- Patient has no clinically significant abnormalities in urinalysis results;
- Patient has acceptable coagulation status as indicated by a Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within 15% of normal limits;
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
Who cannot join
- Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:
- Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period;
- Any prior history of cerebrovascular accident, transient ischemic attack, or pre-existing carotid artery disease.
- Known allergy to hyaluronidase;
- Current use of megestrol acetate (use within 10 days of Day 1);
- Contraindication to heparin including prior heparin induced thrombocytopenia (HIT), recent CNS bleed; intracranial or spinal lesion at high risk for bleeding; severe platelet dysfunction; recent major operation at high risk for bleeding; underlying hemorrhagic coagulopathy; high risk for falls; potential need for spinal anesthesia/lumbar puncture; active bleeding;
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- Women currently pregnant or breastfeeding;
- Intolerance to dexamethasone;
- Inability to comply with study and follow-up procedures as judged by the Investigator;
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;
- Patient has known infection with HIV, hepatitis B, or hepatitis C;
- Patient has a history of allergy or hypersensitivity to any of the agents they are supposed to receive (or to any of the excipients for those agents);
- Patient has 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, these can include New York Heart Association Functional Class ≥ 3, myocardial infarction within the past 12 months before screening, pre-existing atrial fibrillation, symptomatic COPD.
- Patient is unwilling or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma
This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma.
Read the detailed description
This is a pilot trial evaluating the safety and potential efficacy of PEGylated Recombinant Human Hyaluronidase (PEGPH20) plus concurrent Gemcitabine and radiotherapy. Recognizing that PEGPH20 has not been previously delivered with radiotherapy but is unlikely to contribute to increased toxicities, this trial will have an abbreviated sequential dose escalation schema for the first three patients. PEGPH20 will be given twice per week for the first 28 days and then weekly for another 2 weeks during radiotherapy. Gemcitabine will be delivered weekly at the first day of radiotherapy and continued weekly, per published literature. Patients will remain on study for three months. The duration of active treatment with PEGPH20 and Gemcitabine plus radiotherapy will continue for 5-6 weeks. Efficacy outcome will occur 6-8 weeks after the completion of radiotherapy.
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Being tested
- PEGylated Recombinant Human Hyaluronidase (PEGPH20), Gemcitabine, Radiation
- Keywords
- Pancreas Cancer, Unresectable, Chemoradiation, PEGPH20
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGylated Recombinant Human Hyaluronidase (PEGPH20)Drug
Also called PEGylated rHuPH20
PEGPH20 Dosing (Cohort I, Dose Escalation, First 3 patients): Administered as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute:
Dose level 1 - 1 mcg/kg; Dose level 2 - 1.6 mcg/kg; Dose level 3 - 3 mcg/kg.
PEGPH20 Dosing (Cohort II, Patients 4-10): Administered at a dose of 3 mcg/kg as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute.
Dosing Schedule: Twice per week beginning Day #1 for 8 doses, then weekly until end of radiotherapy.
GemcitabineDrug
Also called Gemzar
Gemcitabine Dosing: Administered at a dose of 600 mg/m2 as an IV infusion over 30 - 60 minutes with standard antiemetic pre-medication. If administered on PEGPH20 day, Gemcitabine will be infused 2-4 Hours after PEGPH20 infusion is completed.
Dosing Schedule: Weekly, beginning Day #2, per standard regimen.
RadiationRadiation
Radiotherapy, beginning Day #2, delivered at 1.8 Gy per fraction, 5 fractions per week (Monday - Friday), until a total dose of 50.4 to 54 Gy for up to 6 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Cohort I (PEGPH20 Dose Escalation + Gemcitabine and Concurrent Radiotherapy), First 3 Patients:
An abbreviated sequential dose escalation schema for the first 3 patients (each subsequent patient will be accrued only after no dose limiting toxicities are found in the first 2 weeks of concurrent therapy for the previous patient).
Intravenous (IV) PEGPH20, per dose escalation guidelines for first 3 patients; Intravenous (IV) Gemcitabine (Standard Regimen); Radiotherapy (Standard Regimen);
Cohort II (PEGPH20 + Gemcitabine and Concurrent Radiotherapy), Patients 4 - 10:
IV PEGPH20, per dosing level determined in dose escalation (Cohort I); IV Gemcitabine (Standard Regimen); Radiotherapy (Standard Regimen); Receives: Drug: PEGylated Recombinant Human Hyaluronidase (PEGPH20); Drug: Gemcitabine; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Related Adverse Events (AEs)
Adverse events will be assessed weekly, from Day1 Treatment through up to 8 weeks after the end of treatment. Safety will be assessed during the study by evaluation of AEs, clinical safety laboratory tests (hematology, blood chemistry (including C-reactive protein [CRP]), coagulation, urinalysis, and PEGPH20 immunogenicity), vital signs, 12-lead ECGs, and physical examinations.
The severity of AEs will be graded by Investigators using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Measured: Up to 8 Weeks After the End of Treatment
Secondary outcomes (8)
Overall Tumor Response Rate
CT Chest/Abdomen/Pelvis will be completed at End of Study Visit. End of Study visit will be done 6-8 weeks after the last day of radiotherapy. The evaluation of overall lesion response will be a composite of the target lesion response, non-target lesion response and presence of new lesions, per RECIST 1.1 criteria.
Measured: Change from Baseline through 8 Weeks After End of Radiation Therapy
Conversion to Resectability Rate
Number of enrolled subjects completing at least 2 weeks of PEGPH20 plus concurrent gemcitabine and radiotherapy who meet institutional surgical criteria for surgical resectability, as determined by End of Study CT imaging. End of Study CT imaging will be done up to 8 weeks after the end of radiation therapy.
Measured: Up to 8 Weeks After End of Radiation Therapy
Carcinoembryonic Antigen (CEA) Response
Change in CEA serum levels from Day 1 through 8 weeks after end of treatment will be assessed.
Measured: Change from Day 1 through 8 Weeks After End of Treatment
CA 19-9 Response
Change in CA 19-9 serum levels from Day 1 through 8 weeks after end of treatment will be assessed.
Measured: Change from Day 1 through 8 Weeks After End of Treatment
Determine the Maximum or Peak Plasma PEGPH20 Concentration (cmax) at End of Infusion
Maximum Plasma PEGPH20 concentration (cmax) will be analyzed in all patients, at the following time points:
Day 1: Pre-Dose; Day 1 Post-Dose @ 1hr, 2hr, 6hr; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37 (24 Hr Post Dose); Day 38 (48Hr Post Dose); Day 39 (72 Hr Post Dose);
Pharmacokinetic (PK) data will analyzed by non-compartmental analysis (NCA).
Measured: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine Plasma PEGPH20 Area Under the Curve (AUC) After Day 1 PEGPH20 Infusion
Plasma PEGPH20 Area Under the Curve (AUC) will be analyzed in all patients, at the following time points:
Day 1: Pre-Dose; Day 1 Post-Dose @ 1hr, 2hr, 6hr; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37 (24 Hr Post Dose); Day 38 (48Hr Post Dose); Day 39 (72 Hr Post Dose);
Pharmacokinetic (PK) data will analyzed by non-compartmental analysis (NCA).
Measured: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine the Maximum or Peak Plasma Hyaluronan Concentration (cmax) After First Dose of PEGPH20
Plasma Hyaluronan (HA) will be analyzed in all patients, at the following time points:
Day 1: Pre-Dose; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37(24 Hr Post Dose); Day 38(48Hr Post Dose); Day 39 (72 Hr Post Dose);
Hyaluronan pharmacodynamic (PD) data will analyzed by non-compartmental analysis (NCA).
Measured: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine Plasma Hyaluronan Area Under Effect Curve (AUEC) After First Dose of PEGPH20
Plasma Hyaluronan (HA) will be analyzed in all patients, at the following time points:
Day 1: Pre-Dose; Day 2 (24Hr Post Dose); Day 3 (48Hr Post Dose); Day 4 (72Hr Post Dose); Day 8: Pre-Dose; Day 9 (24Hr Post Dose); Day 10 (48Hr Post Dose); Day 11 (72 Hr Post Dose); Day 36: Pre-Dose; Day 37(24 Hr Post Dose); Day 38(48Hr Post Dose); Day 39 (72 Hr Post Dose);
Hyaluronan pharmacodynamic (PD) data will analyzed by non-compartmental analysis (NCA).
Measured: At Specific Timepoints from Day 1 through Day 39 During Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start3 Jan 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Why it stopped: Safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Sigal, MD, Scripps Health
- Investigators
- Darren S Sigal, MD, Principal investigator, Scripps Health/Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910882
- Sponsor's protocol ID
- PEGPH20-GEM-XRT
- Acronym
- HALO-IST
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Baumgartner G, Gomar-Hoss C, Sakr L, Ulsperger E, Wogritsch C. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy. Cancer Lett. 1998 Sep 11;131(1):85-99.
PubMed 9839623Hingorani S, Harris WP, Beck JT, Berdov BA, Wagner SA, Pshevlotskyet EM, et al. Final Results of a Phase 1b Study of Gemcitabine Plus PEGPH20 in Patients With Stage IV Previously Untreated Pancreatic Cancer. ASCO 2015 Gastrointestinal Cancers Symposium, Poster Abstract 359.
Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. doi: 10.1200/JCO.2011.34.8904. Epub 2011 Oct 3.
PubMed 21969502Vaupel P, Thews O, Hoeckel M. Treatment resistance of solid tumors: role of hypoxia and anemia. Med Oncol. 2001;18(4):243-59. doi: 10.1385/MO:18:4:243.
PubMed 11918451Provenzano PP, Hingorani SR. Hyaluronan, fluid pressure, and stromal resistance in pancreas cancer. Br J Cancer. 2013 Jan 15;108(1):1-8. doi: 10.1038/bjc.2012.569. Epub 2013 Jan 8.
PubMed 23299539Li X, Jiang P, Symons R, et al. Pegylated human recombinant hyaluronidase PH20 reduces solid tumor hypoxia [abstract]. Cancer Res 2012; 72(8 Suppl): Abstract 3796.
Li X. PEGylated human recombinant hyaluronidase (PEGPH20) removes peritumoral hyaluronan and increases the efficacy of chemotherapy and radiotherapy in an experimental brain metastasis model [abstract]. Cancer Res 2009; 69 (9 Suppl): Abstract 262.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Combining PEGPH20 With Concurrent Gemcitabine and Radiotherapy in Patients With Localized, Unresectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02910882
- Acronym / sponsor ID
- HALO-IST / PEGPH20-GEM-XRT
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Keywords
- Pancreas Cancer, Unresectable, Chemoradiation, PEGPH20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm phase II trial assessing the potential activity of combination PEGPH20 plus Gemcitabine with radiotherapy in ten patients with localized, unresectable pancreatic adenocarcinoma.
Detailed description
This is a pilot trial evaluating the safety and potential efficacy of PEGylated Recombinant Human Hyaluronidase (PEGPH20) plus concurrent Gemcitabine and radiotherapy. Recognizing that PEGPH20 has not been previously delivered with radiotherapy but is unlikely to contribute to increased toxicities, this trial will have an abbreviated sequential dose escalation schema for the first three patients. PEGPH20 will be given twice per week for the first 28 days and then weekly for another 2 weeks during radiotherapy. Gemcitabine will be delivered weekly at the first day of radiotherapy and continued weekly, per published literature. Patients will remain on study for three months. The duration of active treatment with PEGPH20 and Gemcitabine plus radiotherapy will continue for 5-6 weeks. Efficacy outcome will occur 6-8 weeks after the completion of radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: PEGylated Recombinant Human Hyaluronidase (PEGPH20), Drug: Gemcitabine, Radiation: RadiationCohort I (PEGPH20 Dose Escalation + Gemcitabine and Concurrent Radiotherapy), First 3 Patients: An abbreviated sequential dose escalation schema for the first 3 patients (each subsequent patient will be accrued only after no dose limiting toxicities are found in the first 2 weeks of concurrent therapy for the previous patient). Intravenous (IV) PEGPH20, per dose escalation guidelines for first 3 patients; Intravenous (IV) Gemcitabine (Standard Regimen); Radiotherapy (Standard Regimen); Cohort II (PEGPH20 + Gemcitabine and Concurrent Radiotherapy), Patients 4 - 10: IV PEGPH20, per dosing level determined in dose escalation (Cohort I); IV Gemcitabine (Standard Regimen); Radiotherapy (Standard Regimen); |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form;
- For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study. Effective contraceptive methods consist of prior sterilization, intra-uterine device, oral or injectable contraceptives, and/or barrier methods. Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study;
- Patients with previously untreated localized, unresectable histologically confirmed pancreatic adenocarcinoma (unresectable will be defined as locally advanced disease or when patients cannot have or refuse surgery);
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L;
- Platelets ≥ 100 x 109/L;
Key exclusion criteria (14 listed)
- Subjects are ineligible for enrollment if they meet any of the following exclusion criteria:
- Clinical evidence of deep vein thrombosis (DVT), pulmonary embolism (PE) or other known thromboembolic (TE) event present during the screening period;
- Any prior history of cerebrovascular accident, transient ischemic attack, or pre-existing carotid artery disease.
- Known allergy to hyaluronidase;
- Current use of megestrol acetate (use within 10 days of Day 1);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGylated Recombinant Human Hyaluronidase (PEGPH20)Also: PEGylated rHuPH20PEGPH20 Dosing (Cohort I, Dose Escalation, First 3 patients): Administered as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute: Dose level 1 - 1 mcg/kg; Dose level 2 - 1.6 mcg/kg; Dose level 3 - 3 mcg/kg. PEGPH20 Dosing (Cohort II, Patients 4-10): Administered at a dose of 3 mcg/kg as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute. Dosing Schedule: Twice per week beginning Day #1 for 8 doses, then weekly until end of radiotherapy. | Drug | Single Arm |
| GemcitabineAlso: GemzarGemcitabine Dosing: Administered at a dose of 600 mg/m2 as an IV infusion over 30 - 60 minutes with standard antiemetic pre-medication. If administered on PEGPH20 day, Gemcitabine will be infused 2-4 Hours after PEGPH20 infusion is completed. Dosing Schedule: Weekly, beginning Day #2, per standard regimen. | Drug | Single Arm |
| RadiationRadiotherapy, beginning Day #2, delivered at 1.8 Gy per fraction, 5 fractions per week (Monday - Friday), until a total dose of 50.4 to 54 Gy for up to 6 Weeks. | Radiation | Single Arm |
Primary outcome
Number of Participants with Treatment Related Adverse Events (AEs)
Time frame: Up to 8 Weeks After the End of Treatment
Adverse events will be assessed weekly, from Day1 Treatment through up to 8 weeks after the end of treatment. Safety will be assessed during the study by evaluation of AEs, clinical safety laboratory tests (hematology, blood chemistry (including C-reactive protein [CRP]), coagulation, urinalysis, and PEGPH20 immunogenicity), vital signs, 12-lead ECGs, and physical examinations. The severity of AEs will be graded by Investigators using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
8 secondary outcomes
Overall Tumor Response Rate
Time frame: Change from Baseline through 8 Weeks After End of Radiation Therapy
Conversion to Resectability Rate
Time frame: Up to 8 Weeks After End of Radiation Therapy
Carcinoembryonic Antigen (CEA) Response
Time frame: Change from Day 1 through 8 Weeks After End of Treatment
CA 19-9 Response
Time frame: Change from Day 1 through 8 Weeks After End of Treatment
Determine the Maximum or Peak Plasma PEGPH20 Concentration (cmax) at End of Infusion
Time frame: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine Plasma PEGPH20 Area Under the Curve (AUC) After Day 1 PEGPH20 Infusion
Time frame: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine the Maximum or Peak Plasma Hyaluronan Concentration (cmax) After First Dose of PEGPH20
Time frame: At Specific Timepoints from Day 1 through Day 39 During Treatment
Determine Plasma Hyaluronan Area Under Effect Curve (AUEC) After First Dose of PEGPH20
Time frame: At Specific Timepoints from Day 1 through Day 39 During Treatment
Results and safety
The study was stopped early (reason given: Safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 9839623Baumgartner G, Gomar-Hoss C, Sakr L, Ulsperger E, Wogritsch C. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy. Cancer Lett. 1998 Sep 11;131(1):85-99.
- BackgroundHingorani S, Harris WP, Beck JT, Berdov BA, Wagner SA, Pshevlotskyet EM, et al. Final Results of a Phase 1b Study of Gemcitabine Plus PEGPH20 in Patients With Stage IV Previously Untreated Pancreatic Cancer. ASCO 2015 Gastrointestinal Cancers Symposium, Poster Abstract 359.
- Background: PubMed 21969502Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. doi: 10.1200/JCO.2011.34.8904. Epub 2011 Oct 3.
- Background: PubMed 11918451Vaupel P, Thews O, Hoeckel M. Treatment resistance of solid tumors: role of hypoxia and anemia. Med Oncol. 2001;18(4):243-59. doi: 10.1385/MO:18:4:243.
- Background: PubMed 23299539Provenzano PP, Hingorani SR. Hyaluronan, fluid pressure, and stromal resistance in pancreas cancer. Br J Cancer. 2013 Jan 15;108(1):1-8. doi: 10.1038/bjc.2012.569. Epub 2013 Jan 8.
- BackgroundLi X, Jiang P, Symons R, et al. Pegylated human recombinant hyaluronidase PH20 reduces solid tumor hypoxia [abstract]. Cancer Res 2012; 72(8 Suppl): Abstract 3796.
- BackgroundLi X. PEGylated human recombinant hyaluronidase (PEGPH20) removes peritumoral hyaluronan and increases the efficacy of chemotherapy and radiotherapy in an experimental brain metastasis model [abstract]. Cancer Res 2009; 69 (9 Suppl): Abstract 262.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren S Sigal, MD principal investigator
Scripps Health/Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEGylated Recombinant Human Hyaluronidase (PEGPH20), Gemcitabine and Radiation in people with Pancreatic Adenocarcinoma Non-resectable, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Safety). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Related Adverse Events (AEs) (time frame: Up to 8 Weeks After the End of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910882, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.