Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer

NCT ID: NCT02653313

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-05-31

Brief Summary

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Detailed Description

Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.

Initially four equal doses of ParvOryx will be administered intravenously on four consecutive days. Seven to fourteen days after the first intravenous administration the drug will be injected directly in a hepatic metastasis of the pancreatic cancer.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ParvOryx

ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).

Group Type: EXPERIMENTAL

Parvovirus H-1 (H-1PV)

Intervention Type: DRUG

Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer.

The total dose levels are: 1E09, 5E09 and 1E10 pfu.

Interventions

Parvovirus H-1 (H-1PV)

Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer.

The total dose levels are: 1E09, 5E09 and 1E10 pfu.

Intervention Type: DRUG

Other Intervention Names

ParvOryx

Eligibility Criteria

Inclusion Criteria

1. Age at least 18 year,

2. Ability to give informed consent,

3. Histologically confirmed pancreatic ductal adenocarcinoma (PAD) with at least one measurable hepatic metastasis according to RECIST 1.1,

4. Disease progression despite first line therapy (whatever chemotherapy regimen),

5. Eligibility for second line chemotherapy with gemcitabine,

6. ECOG performance scale 0 or 1,

7. Consent for the sampling and investigations of biological specimens as scheduled by the trial protocol,

8. Adequate bone marrow function: neutrophils >1.5 x 1E09/L, platelets >100 x 1E09/L, hemoglobin >9.0 g/dL,

9. Liver function tests (LFT) within the following range: Bilirubin <3 x ULN (Upper Limit of Normal); ASAT and ALAT <5 x ULN,

10. Adequate renal function: Creatinine <1.5 g/dL,

11. Adequate blood clotting: aPTT <39 sec, INR <1.2,

12. Normal thyroid function, i.e. TSH, fT3 and fT4 within the normal range (TSH: 0.4 - 4.0 mU/l, fT3: 2.0 - 4.2 ng/l, fT4: 8 - 18 ng/l)

13. Negative serology for HIV, HBV and HCV,

14. Negative Beta-HCG test in blood in woman of childbearing potential,

15. Use of adequate contraception in both genders, i.e. use of double-effective method of contraception for the entire participation in the trial.

Exclusion Criteria

1. Eligibility for surgical treatment,

2. Symptomatic cerebral, pulmonal, and/or osseous metastases,

3. Peritoneal carcinosis,

4. Liver cirrhosis,

5. Splenectomy,

6. Relevant respiratory impairment, corresponding to the grade IV or V of the MRC Breathlessness Scale (stops for breath after walking about 100 meters or after a few minutes on level ground, or too breathless to leave the house, or breathless when undressing),

7. Positive anti-drug antibodies (ADAs) against ParvOryx,

8. Hospitalization due to other conditions than the pancreatic cancer within the last 3 months,

9. Chemotherapy within 2 weeks prior to the first administration of the IMP,

10. Signs of active, systemic infection within 7 days prior to the study inclusion (clinical symptoms (cough, running nose, burning sensation while urinating, apparent skin or wound infection) and/or increase of fever and/or deterioration of infection-specific laboratory parameters beyond changes apparently driven by the underlying pancreatic cancer),

11. Radiotherapy within 6 weeks prior to the study inclusion,

12. Contraindications for CT,

13. Known allergy to iodinated contrast media,

14. Participation in another interventional trial within the last 30 days,

15. Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oryx GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernard Huber, Dr.

Role: STUDY_DIRECTOR

Oryx GmbH & Co. KG

Guy Ungerechts, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

National Center for Tumor Diseases, Heidelberg

Locations

National Center for Tumor Diseases (NCT)

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

Hajda J, Lehmann M, Krebs O, Kieser M, Geletneky K, Jager D, Dahm M, Huber B, Schoning T, Sedlaczek O, Stenzinger A, Halama N, Daniel V, Leuchs B, Angelova A, Rommelaere J, Engeland CE, Springfeld C, Ungerechts G. A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. BMC Cancer. 2017 Aug 29;17(1):576. doi: 10.1186/s12885-017-3604-y.

Reference Type: BACKGROUND

PMID: 28851316 (View on PubMed)

Hajda J, Leuchs B, Angelova AL, Frehtman V, Rommelaere J, Mertens M, Pilz M, Kieser M, Krebs O, Dahm M, Huber B, Engeland CE, Mavratzas A, Hohmann N, Schreiber J, Jager D, Halama N, Sedlaczek O, Gaida MM, Daniel V, Springfeld C, Ungerechts G. Phase 2 Trial of Oncolytic H-1 Parvovirus Therapy Shows Safety and Signs of Immune System Activation in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2021 Oct 15;27(20):5546-5556. doi: 10.1158/1078-0432.CCR-21-1020. Epub 2021 Aug 23.

Reference Type: BACKGROUND

PMID: 34426438 (View on PubMed)

Other Identifiers

ParvOryx02

Identifier Type: -

Identifier Source: org_study_id