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Anti-metabolites

nab-Paclitaxel for Endocrine Tumors (apact Trial)

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up date of randomization up to data cut off date of 31 december 2018; median dfs follow-up time for censored participants was 22.242 months for nab-paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
Awards & highlights

Summary

This study is evaluating whether nab-paclitaxel in combination with gemcitabine can prevent or delay recurrence of pancreatic cancer.

Eligible Conditions
  • Endocrine Tumors
  • Endocrine Disorders
  • Gemcitabine
  • Anticancer Drugs
  • Gastrointestinal Disorders
  • Tumors
  • Pancreatic Disease
  • Pancreatic Cancer
  • Digestive System Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~date of randomization up to data cut off date of 31 december 2018; median dfs follow-up time for censored participants was 22.242 months for nab-paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization up to data cut off date of 31 december 2018; median dfs follow-up time for censored participants was 22.242 months for nab-paclitaxel and gemcitabine and 13.832 months for gemcitabine alone for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
Secondary outcome measures
Kaplan Meier Estimate of Overall Survival (OS)
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)

Side effects data

From 2016 Phase 2 & 3 trial • 191 Patients • NCT01881230
55%
Fatigue
55%
Alopecia
43%
Nausea
42%
Diarrhoea
42%
Anaemia
40%
Neutropenia
30%
Vomiting
28%
Oedema peripheral
28%
Headache
25%
Decreased appetite
23%
Myalgia
23%
Peripheral sensory neuropathy
22%
Asthenia
22%
Arthralgia
22%
Constipation
20%
Pyrexia
20%
Cough
15%
Dysgeusia
13%
Rash
13%
Thrombocytopenia
13%
Hypokalaemia
13%
Hypertension
13%
Weight decreased
13%
Pain in extremity
13%
Insomnia
12%
Bone pain
12%
Dyspnoea
10%
Non-cardiac chest pain
10%
Upper respiratory tract infection
10%
Alanine aminotransferase increased
10%
Aspartate aminotransferase increased
10%
Dehydration
8%
Pleural effusion
8%
Abdominal pain upper
8%
Stomatitis
8%
Pruritus
7%
Oropharyngeal pain
7%
Pneumonia
7%
Cellulitis
7%
Neurotoxicity
7%
Paraesthesia
7%
Hot flush
7%
Fall
7%
Chills
7%
Folliculitis
7%
Leukopenia
7%
Hyperglycaemia
7%
Neuropathy peripheral
7%
Depression
7%
Erythema
7%
Abdominal pain
5%
Epistaxis
5%
Dry mouth
5%
Gastrooesophageal reflux disease
5%
Generalised oedema
5%
Influenza like illness
5%
Pain
5%
Sinusitis
5%
Urinary tract infection
5%
Spinal pain
5%
Anxiety
5%
Rash maculo-papular
5%
Rash pruritic
5%
Tachycardia
5%
Back pain
5%
Musculoskeletal chest pain
5%
Dizziness
5%
Rhinorrhoea
5%
Dyspepsia
5%
Drug hypersensitivity
5%
Neck pain
5%
Dry skin
5%
Vision blurred
3%
Bronchitis
3%
Hypoaesthesia
3%
Dyspnoea exertional
3%
Lymphoedema
2%
Breast cellulitis
2%
Haematemesis
2%
Haemorrhoidal haemorrhage
2%
Cardiac failure
2%
Palpitations
2%
Device related infection
2%
Metastases to meninges
2%
Respiratory tract congestion
2%
Lymphopenia
2%
Lacrimation increased
2%
Contusion
2%
Overdose
2%
Musculoskeletal pain
2%
Atrial fibrillation
2%
Sensory disturbance
2%
Influenza
2%
Hypomagnesaemia
2%
Ascites
2%
Endocarditis
2%
Respiratory failure
2%
Muscular weakness
2%
Device related sepsis
2%
Sepsis
2%
Confusional state
2%
Atelectasis
2%
Pneumothorax
2%
Pulmonary embolism
2%
Deep vein thrombosis
2%
Hepatic failure
2%
Nodular regenerative hyperplasia
2%
Febrile neutropenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nab-Paclitaxel + Gemcitabine
Arm B: Nab-Paclitaxel + Carboplatin
Arm C: Gemcitabine + Carboplatin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: nab-Paclitaxel 125 mg/m^2 plus gemcitabine 1000 mg/m2Experimental Treatment2 Interventions
Participants received nab-Paclitaxel 125 mg/m^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Group II: Gemcitabine 1000 mg/m^2Active Control1 Intervention
Participants received gemcitabine 1000 mg/m^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, subject or physician decision, withdrawal of consent, or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-Paclitaxel
2014
Completed Phase 3
~7680
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
643 Previous Clinical Trials
129,246 Total Patients Enrolled
Brian Lu, M.D., PhDStudy DirectorCelgene Corporation
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,536 Previous Clinical Trials
3,374,941 Total Patients Enrolled
~77 spots leftby Jul 2025