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Anti-metabolites

Gemcitabine + Nab-Paclitaxel for Pancreatic Cancer

Phase 2
Recruiting
Led By Laith Abushahin, MBBS
Research Sponsored by Laith Abushahin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has one or more metastatic tumors measurable by computed tomography (CT) scan (or magnetic resonance imaging [MRI], if patient is allergic to CT contrast media or if the tumor is difficult to delineate on CT scan) as defined by RECIST 1.1 criteria
Participant has definitive histologically or cytologically confirmed adenocarcinoma of the pancreas. The definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Participants with islet cell neoplasms are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is studying a new way of giving gemcitabine and nab-paclitaxel to see if it works better than the standard way in treating pancreatic cancer.

Who is the study for?
This trial is for adults with metastatic pancreatic adenocarcinoma confirmed by tissue analysis. Participants must have measurable tumors, not be pregnant or breastfeeding, and agree to use effective contraception. No prior chemotherapy for metastatic cancer is allowed, but past adjuvant therapy over 6 months ago is acceptable. They need a certain level of blood cells (neutrophils, platelets) and hemoglobin.
What is being tested?
The study tests an optimized infusion schedule of two chemotherapy drugs: Gemcitabine and Nab-paclitaxel in patients with advanced pancreatic cancer. The goal is to see if changing the timing of Nab-paclitaxel improves treatment outcomes.
What are the potential side effects?
Potential side effects include nausea, fatigue, hair loss, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or pain in hands and feet (neuropathy), and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have at least one tumor that can be measured on a CT or MRI scan.
Select...
I have been diagnosed with a specific type of pancreatic cancer, not islet cell cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate
Secondary study objectives
Disease control rate
Incidence of adverse events (AEs)
Overall survival (OS)
+2 more

Side effects data

From 2016 Phase 3 trial • 50 Patients • NCT02019277
70%
Diarrhoea
68%
Fatigue
56%
Neuropathy peripheral
54%
Alopecia
52%
Rash
46%
Nausea
38%
Upper respiratory tract infection
36%
Myalgia
34%
Vomiting
34%
Headache
28%
Muscle spasms
24%
Nail disorder
24%
Gastrooesophageal reflux disease
24%
Epistaxis
24%
Arthralgia
22%
Pain in extremity
20%
Back pain
20%
Urinary tract infection
18%
Dizziness
18%
Cough
18%
Constipation
16%
Neutropenia
16%
Dry skin
14%
Pyrexia
14%
Paronychia
14%
Dysgeusia
14%
Oropharyngeal pain
14%
Pruritus
14%
Hot flush
12%
Hypertension
12%
Dry eye
12%
Stomatitis
12%
Decreased appetite
12%
Musculoskeletal pain
12%
Insomnia
12%
Dyspnoea
10%
Peripheral sensory neuropathy
10%
Abdominal pain
10%
Mucosal inflammation
10%
Lethargy
8%
Lacrimation increased
8%
Febrile neutropenia
8%
Rash pustular
8%
Chills
8%
Anaemia
8%
Oedema peripheral
8%
Oral candidiasis
8%
Sinusitis
8%
Anxiety
8%
Rhinorrhoea
8%
Acne
8%
Erythema
6%
Musculoskeletal chest pain
6%
Injection site reaction
6%
Skin lesion
6%
Conjunctivitis
6%
Nail infection
6%
Chest pain
6%
Tachycardia
6%
Abdominal pain upper
6%
Dry mouth
6%
Dyspepsia
6%
Chest discomfort
6%
Pain
6%
Hypocalcaemia
6%
Bone pain
6%
Depression
6%
Dyspnoea exertional
6%
Dermatitis acneiform
6%
Lymphoedema
6%
Weight decreased
6%
Tooth extraction
4%
Pulmonary embolism
4%
Cellulitis
2%
Device related infection
2%
Gastroenteritis
2%
Wound infection
2%
Femur fracture
2%
Breast cancer
2%
Syncope
2%
Psychotic disorder
2%
Dermatitis bullous
2%
Cardiac failure
2%
Drug hypersensitivity
2%
Gastritis
2%
Dermatomyositis
2%
Oesophagitis
2%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab, Pertuzumab, and Taxane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, nab-paclitaxel)Experimental Treatment2 Interventions
Patients receive gemcitabine IV over 30 minutes on days 1 and 15 and nab-paclitaxel IV over 30 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved
Albumin human
FDA approved

Find a Location

Who is running the clinical trial?

Laith AbushahinLead Sponsor
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,007 Total Patients Enrolled
Anne NoonanLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
~10 spots leftby Nov 2025
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