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Epigenetic modifying agent
CC-486 for Non-Small Cell Lung Cancer (abound2L+ Trial)
Phase 2
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 up to 16 jan 2017 for cc-486 + nab-paclitaxel and up to 23 dec 2017 for nab-paclitaxel and durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, cc-486 + nab-paclitaxel and durva + nab-paclitaxel
Awards & highlights
abound2L+ Trial Summary
This trial will test the effectiveness of two different drugs, either alone or in combination, as a second or third line of treatment for advanced non-small cell lung cancer.
Eligible Conditions
- Non-Small Cell Lung Cancer
abound2L+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 jan 2017 for cc-486 + nab-paclitaxel and up to 23 dec 2017 for nab-paclitaxel and durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, cc-486 + nab-paclitaxel and durva + nab-paclitaxel
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 jan 2017 for cc-486 + nab-paclitaxel and up to 23 dec 2017 for nab-paclitaxel and durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, cc-486 + nab-paclitaxel and durva + nab-paclitaxel
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 of Progression-Free Survival (PFS) as Assessed by the Investigator
Secondary outcome measures
Dose Intensity Per Week of CC-486
Dose Intensity Per Week of Durvalumab
Dose Intensity Per Week of Nab-Paclitaxel
+6 moreSide effects data
From 2023 Phase 2 trial • 240 Patients • NCT0225032657%
Nausea
53%
Vomiting
42%
Diarrhoea
41%
Constipation
34%
Decreased appetite
33%
Asthenia
32%
Alopecia
30%
Fatigue
24%
Peripheral sensory neuropathy
20%
Cough
20%
Dyspnoea
19%
Neutropenia
15%
Anaemia
15%
Oedema peripheral
14%
Arthralgia
13%
Pyrexia
13%
Paraesthesia
11%
Headache
11%
Weight decreased
11%
Myalgia
11%
Insomnia
10%
Stomatitis
10%
Dizziness
9%
Pulmonary embolism
9%
Abdominal pain
9%
Musculoskeletal pain
8%
Pleural effusion
8%
Dry skin
8%
Pain in extremity
6%
Neutrophil count decreased
6%
Muscle spasms
6%
Leukopenia
6%
Dyspepsia
6%
Pneumonia
6%
Nasopharyngitis
6%
Oral candidiasis
6%
Anxiety
5%
Haemorrhoids
5%
Back pain
5%
General physical health deterioration
5%
Vision blurred
5%
Haemoptysis
5%
Vertigo
5%
Muscular weakness
4%
Productive cough
4%
Upper respiratory tract infection
4%
Abdominal pain upper
4%
Non-cardiac chest pain
4%
Epistaxis
4%
Musculoskeletal chest pain
4%
Hypophosphataemia
3%
Urinary tract infection
3%
Rhinorrhoea
3%
Hypomagnesaemia
3%
Alanine aminotransferase increased
3%
Performance status decreased
3%
Respiratory tract infection
3%
Bronchitis
3%
Hypotension
3%
Cancer pain
1%
Generalised tonic-clonic seizure
1%
Hemiparesis
1%
Blood glucose increased
1%
Hyponatraemia
1%
Abdominal wall abscess
1%
Lower respiratory tract infection
1%
Paraparesis
1%
Intestinal obstruction
1%
Confusional state
1%
Acute kidney injury
1%
Haematuria
1%
Acute respiratory distress syndrome
1%
Interstitial lung disease
1%
Flushing
1%
Circulatory collapse
1%
Influenza
1%
Febrile neutropenia
1%
Metastases to meninges
1%
Flatulence
1%
Urinary tract obstruction
1%
Respiratory distress
1%
Pneumonia pneumococcal
1%
Sudden death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nab-Paclitaxel + CC-486 Combination Arm
Nab-Paclitaxel + Durvalumab Combination Arm
Nab-Paclitaxel Monotherapy Arm
abound2L+ Trial Design
3Treatment groups
Experimental Treatment
Group I: Nab-paclitaxel and Durvalumab combinationExperimental Treatment2 Interventions
subjects in the nab-Paclitaxel/durvalumab combination arm will receive nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and durvalumab 1125 mg IV infusion over approximately 1 hour on Day 15 of each 21-day treatment cycle
Group II: Monotherapy arm: nab-paclitaxel IV infusionExperimental Treatment1 Intervention
Subjects in the monotherapy arm will receive nab-Paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle
Group III: Combination arm: nab-paclitaxel and CC-486Experimental Treatment2 Interventions
Subjects in the combination arm will receive nab-paclitaxel 100 mg^/m2 intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg orally daily (QD) on Days 1 to14 of each 21-day treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duravalumab
2015
Completed Phase 2
~240
CC-486
2015
Completed Phase 2
~670
nab-paclitaxel IV
2015
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
643 Previous Clinical Trials
130,337 Total Patients Enrolled
Teng Jin Teng Jin Ong, MDStudy DirectorCelgene
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,520 Previous Clinical Trials
3,371,973 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have any other cancer that needs to be treated.You have a history of lung diseases, including interstitial lung disease.You have received a specific type of immunotherapy called anti-PD-1 or anti-PD-L1 in the past.You received a live vaccine within 30 days before the first dose of the study drug.Your disease cannot be measured at the beginning of the study.You have had an allergic reaction in the past to the study drug or any of its ingredients.You have any other important medical condition, mental illness, or problems with your organs.You have received an organ transplant from someone else in the past.You have a medical condition that could make it difficult to understand or analyze the study results.Male patients who are not willing to use effective birth control.You had another type of cancer within the last 5 years before starting this study.You have received radiation therapy within the last 4 weeks or limited radiation therapy for pain relief within the last 2 weeks before starting the investigation product.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy arm: nab-paclitaxel IV infusion
- Group 2: Combination arm: nab-paclitaxel and CC-486
- Group 3: Nab-paclitaxel and Durvalumab combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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