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Anti-metabolites

nab-Paclitaxel for Cancer (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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a combination of two chemotherapy drugs, nab-Paclitaxel and gemcitabine, can better prevent the return of pancreatic cancer after surgery compared to using gemcitabine alone. The study focuses on patients who have had their pancreatic cancer surgically removed. The drugs work by stopping cancer cells from growing and multiplying. Nab-paclitaxel has shown superior antitumor activity and increased survival rates in combination with gemcitabine for treating advanced pancreatic cancer.

Eligible Conditions

Cancer
Head and Neck Cancers
Pancreatic Disease
Endocrine Cancer
Endocrine Disorder
Gemcitabine
Tumors
Congenital Hepatobiliary Disorders
Endocrine Disorders
Digestive Cancer
Benign Hepatobiliary Disease
Endocrine Tumors
Pancreatic Cancer
Anticancer Drugs
Digestive System Tumors

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee

Secondary study objectives

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

Haemorrhoidal haemorrhage

Haematemesis

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Gemcitabine

2017

Completed Phase 3

~1920

nab-Paclitaxel

2014

Completed Phase 3

~7680