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Evaluation of blood levels of Paclynap produced drug in Iran in comparison with Abraxan in pancreatic cancer patients

Pharmacokinetic evaluation of Paclynap formulation in comparison with Abraxan in pancreatic cancer patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016041118745N4
Enrollment
20
Registered
2016-06-10
Start date
2016-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas cancer. Malignant neoplasm of pancreas

Interventions

Intervention 1: The randomized crossover study will be performed on two groups. The first group which will initially receive abraxan: This group will initially receive abraxan (125 mg / m2 of body sur
Treatment - Drugs
The randomized crossover study will be performed on two groups. The first group which will initially receive abraxan: This group will initially receive abraxan (125 mg / m2 of body surface area at the
The second group which will initially receive paclynap: This group will initially receive paclynap (125 mg / m2 of body surface area at the first cycle at days 1, 8 and 15). Then in the next cycle aft

Sponsors

Nano Daru Pajuhan Pardis Co
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: inclusion criteria: with written consent; patients with Local Advanced Pancreatic Cancer. exclusion criteria: patients with hepatic and renal disorders; patients with acute and chronic heart disease; patients with pulmonary and cerebral metastasis; patient with decreased albumin levels of two times of normal; patients with enhanced blood bilirubin of 3 times over.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Paclytaxel serum level. Timepoint: 30 min, one, two, four, six, eight, twelve, twenty four, forty eight hours after injection. Method of measurement: High fluid pressure chromatography.

Secondary

MeasureTime frame
Decrease of tumor. Timepoint: Two months after injection. Method of measurement: Imaging using MRI.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Mohammad Alizadeh

Tehran University of Medical Sciences

aalizadeh@sina.tums.ac.ir+98 21 6119 2798

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026