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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

Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.

Pancreatic cancer surgical staging: Tumor (T) 1-3, Lymph Node (LN) N0-1, Metastasis (M) 0.

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

apact Trial 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
Anticancer Drugs
Gastrointestinal Disorders
Gemcitabine
Tumors
Pancreatic Disease
Pancreatic Cancer
Digestive System Tumors

apact Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

apact Trial Timeline

Screening ~ 3 weeks3 visits

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

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

Pleural effusion

Abdominal pain upper

Stomatitis

Pruritus

Oropharyngeal pain

Pneumonia

Cellulitis

Neurotoxicity

Paraesthesia

Hot flush

Fall

Chills

Folliculitis

Leukopenia

Hyperglycaemia

Neuropathy peripheral

Depression

Erythema

Abdominal pain

Epistaxis

Dry mouth

Gastrooesophageal reflux disease

Generalised oedema

Influenza like illness

Pain

Sinusitis

Urinary tract infection

Spinal pain

Anxiety

Rash maculo-papular

Rash pruritic

Tachycardia

Back pain

Musculoskeletal chest pain

Dizziness

Rhinorrhoea

Dyspepsia

Drug hypersensitivity

Neck pain

Dry skin

Vision blurred

Bronchitis

Hypoaesthesia

Dyspnoea exertional

Lymphoedema

Haematemesis

Haemorrhoidal haemorrhage

Breast cellulitis

Cardiac failure

Palpitations

Device related infection

Metastases to meninges

Respiratory tract congestion

Lymphopenia

Lacrimation increased

Contusion

Overdose

Musculoskeletal pain

Atrial fibrillation

Sensory disturbance

Influenza

Hypomagnesaemia

Ascites

Endocarditis

Respiratory failure

Muscular weakness

Device related sepsis

Sepsis

Confusional state

Atelectasis

Pneumothorax

Pulmonary embolism

Deep vein thrombosis

Hepatic failure

Nodular regenerative hyperplasia

Febrile neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Nab-Paclitaxel + Gemcitabine

Arm B: Nab-Paclitaxel + Carboplatin

Arm C: Gemcitabine + Carboplatin

apact 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