Trial record 1 of 1 for:    HALO-109-202
Previous Study | Return to List | Next Study

PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer (HALO-109-202)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01839487
First received: April 22, 2013
Last updated: April 21, 2014
Last verified: January 2014

April 22, 2013
April 21, 2014
April 2013
August 2015   (final data collection date for primary outcome measure)
Estimate the PFS duration of PEGPH20 combined with NAB plus GEM [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Measured from date of randomization until disease progression or death.
Complete list of historical versions of study NCT01839487 on ClinicalTrials.gov Archive Site
  • Estimate relative benefit of PAG treatment vs. AG treatment, as assessed by the PFS ratio [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Estimate relative benefit of PAG vs AG treatment as assessed by the PFS hazard ratio based on subject tumor-associated HA levels [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Estimate ORR as defined by RECIST 1.1 of PAG treatment and the relative benefit of PAG treatment vs AG treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To estimate the OS duration of PAG treatment and the relative benefit of PAG treatment vs AG treatment, as assessed by the OS hazard ratio. [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety and tolerability profile of PAG and AG treatment groups [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • To characterize the plasma PK of PEGPH20 when given in combination with NAB + GEM [ Time Frame: Various visits and timepoints ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
PEGPH20 Plus Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Untreated Pancreatic Cancer
A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined With Nab-Paclitaxel Plus Gemcitabine Compared With Nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer

To compare the treatment effect of PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with Stage IV pancreatic cancer. Phase 2 (safety and treatment effect), 124 subjects, 1:1 ratio, PAG:AG, preceded by 8 subject Run-In phase (safety and tolerability).

  1. Phase 2, multicenter open-label randomized study with a run-in phase. Run-in phase to evaluate safety and tolerability of PEGPH20 + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine. Phase 2 will be an open-label randomized study with same study drugs evaluating safety and efficacy.
  2. Subjects must have newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer diagnosed by a standard of Care CT scan within 20 days of dosing and meet all inclusion/exclusion criteria.
  3. Treatment consists of 4 week treatment cycles with Week 4 of every cycle, a wash-out week. In Cycle 1, PEGPH20 will be administered twice per week with Nab-paclitaxel + Gemcitabine given once/week 2-4 hrs. after PEGPH20 and nab-paclitaxel + gemcitabine alone
  4. Safety parameters include medical history, physical exams, adverse event and Concomitant med collection, Karnofsky Performance scale, Immunogenicity, Hematology, Chemistry, coagulation, Weight/body surface area (BSA) for dosing, ECG and pharmacokinetics (PK) and Hyaluronan (HA) catabolite levels. Efficacy parameters include standard of care CT scans, CA19-9, tumor analysis of HA.
  5. Subjects continue in study until disease progression, adverse event/toxicity, death or either the subject/sponsor discontinues the study.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Pancreatic Cancer
  • Drug: PEGPH20+nab-paclitaxel+gemcitabine
    PEGPH20 3ug/kg + nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2. PEGPH20 given IV x2/week for Cycle 1 and weekly for Cycle 2 and beyond. Nab-paclitaxel and gemcitabine given IV x1/week for 3 weeks for all cycles.
    Other Names:
    • Abraxane
    • Gemzar
  • Drug: nab-paclitaxel + gemcitabine
    nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 given IV x1/week 3/4 weeks per cycle
    Other Names:
    • Abraxane
    • Gemzar
  • Experimental: PEGPH20
    PEGPH20+nab-paclitaxel+Gemcitabine
    Intervention: Drug: PEGPH20+nab-paclitaxel+gemcitabine
  • Active Comparator: nab-paclitaxel + gemcitabine
    nab-paclitaxel + gemcitabine x1/week
    Intervention: Drug: nab-paclitaxel + gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
September 2015
August 2015   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Signed Informed consent
  • Histologically confirmed Stage IV pancreatic ductal adenocarcinoma w/ documented disseminated neoplasm to liver and /or lung. Must have archival or fresh tissue (block /slides) available pre-dose.
  • One or more measurable metastatic tumors measurable on CT san per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1 ).
  • No previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease.
  • Karnofsky Performance Status >= 70%
  • Life expectancy >= 3 mos
  • Age >= 18 years
  • Screen labs of bilirubin,aspartate transaminase(AST), alanine transaminase(ALT), serum creatinine and albumin, absolute neutrophil count (ANC), hemoglobin, hematocrit and partial thromboplastin time(PTT) within specified values/criteria per protocol prior to dosing.

Key Exclusion Criteria:

  • Non metastatic pancreatic ductal adenocarcinoma
  • Known Central nervous system involvement, brain metastasis
  • New York(NY) Heart Assoc Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
  • Active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy.
  • Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C
  • History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical cancer in-situ.
  • Any other disease, metabolic dysfunction, physical examination finding or clinical lab finding that leads to reasonable suspicion of disease or condition that contraindicates the use of an investigational drug, that may affect interpretation of results, or render the subject at a high risk of treatment complications.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01839487
HALO-109-202
Yes
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Joy Zhu, MD, Ph.D Halozyme Therapeutics
Halozyme Therapeutics
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP