Trial Outcomes & Findings for Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer (NCT NCT02017015)

NCT ID: NCT02017015

Last Updated: 2017-09-26

Results Overview

ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks

Results posted on

2017-09-26

Participant Flow

This multi-center study was conducted by investigators in China and enrolled patients at a total of 13 sites. This study was designed to be a Chinese bridging study to complement the global pivotal study (CA046).

Participant milestones

Participant milestones
Measure	Nab-paclitaxel and Gemcitabine Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Overall Study STARTED	83
Overall Study Safety Population	83
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	69

Reasons for withdrawal

Reasons for withdrawal
Measure	Nab-paclitaxel and Gemcitabine Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	21
Overall Study Death	4
Overall Study Progressive Disease	31
Overall Study Non-compliance with study drug	2
Overall Study Physician Decision	2

Baseline Characteristics

Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-paclitaxel and Gemcitabine n=83 Participants Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Age, Continuous	56.2 years STANDARD_DEVIATION 10.03 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Region of Enrollment China	83 participants n=5 Participants
Karnofsky Performance Status (KPS) 90-100% = normal activity, few symptoms of disease	58 participants n=5 Participants
Karnofsky Performance Status (KPS) 70-80% = normal activity, symptoms, cannot work	25 participants n=5 Participants
Karnofsky Performance Status (KPS) 50-60% = needs help and needs medical care	0 participants n=5 Participants
Karnofsky Performance Status (KPS) <40% = disabled to severely disabled	0 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review 1	3 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review 2	6 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review 3	13 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review 4	10 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review 5	8 participants n=5 Participants
Number of Baseline Lesions (Target + Non-Target) by Independent Radiological Review >5	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks

Population: Intent to Treat (ITT) population included all participants enrolled into the study

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and Gemcitabine n=83 Participants Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)	35 percentage of participants Interval 24.8 to 46.2

SECONDARY outcome

Timeframe: Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks

Population: Safety population includes all enrolled participants who received at least 1 dose of study drug

TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and Gemcitabine n=83 Participants Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) At least 1 TEAE	83 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) At Least 1 Treatment-related TEAE	82 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥ 1 TEAE with NCI CTCAE Gr 3 or higher	70 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥ 1 TRAE NCI CTCAE ≥ Gr 3	62 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) At Least 1 Serious TEAE	20 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) At Least 1 Treatment-related Serious TEAE	9 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥ 1 TEAE causing discontinuing of either drug	10 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥1 TRAE causing discontinuing of either drug	5 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥ 1 TEAE causing reduction in ABI-007/Gemcitabine	38 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥ 1 TRAE causing reduction in ABI-007/Gemcitabine	38 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥1 TEAE causing interruption in either study drug	43 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥1 TRAE causing interruption in either study drug	40 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) At Least 1 TEAE With Outcome of Death	8 participants
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) ≥1 TRAE with Outcome of Death	2 participants

SECONDARY outcome

Timeframe: Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks

Population: Includes participants with a Confirmed Complete or Partial Response

DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and Gemcitabine n=29 Participants Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Duration of Response (DoR) Based on IRR According to RECIST Guidelines	8.9 months Interval 6.01 to 8.94

SECONDARY outcome

Timeframe: From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks

Population: ITT population includes all enrolled participants

Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.

Outcome measures

Outcome measures
Measure	Nab-paclitaxel and Gemcitabine n=83 Participants Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Kaplan-Meier Estimate of Overall Survival (OS)	9.2 months Interval 7.6 to 11.1

Adverse Events

Nab-paclitaxel and Gemcitabine

Serious events: 22 serious events

Other events: 83 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Nab-paclitaxel and Gemcitabine n=83 participants at risk Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Blood and lymphatic system disorders Anaemia	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Febrile neutropenia	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Leukopenia	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Neutropenia	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Cardiac disorders Cardiac failure	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Abdominal pain	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Gastrointestinal obstruction	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Intestinal obstruction	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.4% 2/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Vomiting	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Death	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Disease progression	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Local swelling	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Pyrexia	2.4% 2/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Hepatobiliary disorders Haemobilia	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Hepatobiliary disorders Hepatic function abnormal	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Hepatobiliary disorders Jaundice cholestatic	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Infections and infestations Lymphangitis	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Platelet count decreased	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Cerebral infarction	2.4% 2/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Renal and urinary disorders Renal failure	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Respiratory, thoracic and mediastinal disorders Acute lung injury	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Vascular disorders Deep vein thrombosis	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Vascular disorders Venous thrombosis limb	1.2% 1/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days

Other adverse events

Other adverse events
Measure	Nab-paclitaxel and Gemcitabine n=83 participants at risk Nab-paclitaxel 125 mg/m\^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m\^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
Blood and lymphatic system disorders Anaemia	31.3% 26/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Erythropenia	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Leukopenia	67.5% 56/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Lymphopenia	9.6% 8/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Neutropenia	66.3% 55/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Blood and lymphatic system disorders Thrombocytopenia	54.2% 45/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Abdominal distension	15.7% 13/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Abdominal pain	13.3% 11/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Abdominal pain upper	14.5% 12/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Ascites	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Constipation	27.7% 23/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Diarrhoea	20.5% 17/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Dyspepsia	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Nausea	49.4% 41/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Gastrointestinal disorders Vomiting	39.8% 33/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Asthenia	13.3% 11/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Chills	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Fatigue	47.0% 39/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Oedema peripheral	22.9% 19/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
General disorders Pyrexia	34.9% 29/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Hepatobiliary disorders Hyperbilirubinaemia	14.5% 12/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Infections and infestations Lung infection	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Infections and infestations Upper respiratory tract infection	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Alanine aminotransferase increased	26.5% 22/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Aspartate aminotransferase increased	20.5% 17/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Blood alkaline phosphatase increased	12.0% 10/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations C-reactive protein increased	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Fibrin D dimer increased	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Gamma-glutamyltransferase increased	13.3% 11/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Haemoglobin decreased	60.2% 50/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Neutrophil count decreased	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Platelet count decreased	13.3% 11/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations Weight decreased	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Investigations White blood cell count decreased	13.3% 11/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Decreased appetite	51.8% 43/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hyperglycaemia	20.5% 17/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hypoalbuminaemia	25.3% 21/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hypocalcaemia	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hypokalaemia	18.1% 15/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hyponatraemia	14.5% 12/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Metabolism and nutrition disorders Hypoproteinaemia	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Musculoskeletal and connective tissue disorders Arthralgia	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Musculoskeletal and connective tissue disorders Back pain	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Musculoskeletal and connective tissue disorders Myalgia	9.6% 8/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Dizziness	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Headache	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Hypoaesthesia	31.3% 26/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Neuritis	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Nervous system disorders Neuropathy peripheral	12.0% 10/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Psychiatric disorders Insomnia	20.5% 17/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Respiratory, thoracic and mediastinal disorders Cough	10.8% 9/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Alopecia	36.1% 30/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Nail disorder	8.4% 7/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Pigmentation disorder	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Pruritus	6.0% 5/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Rash	10.8% 9/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days
Skin and subcutaneous tissue disorders Skin hyperpigmentation	7.2% 6/83 • TEAE that started: 1) From the date of first dose of study drug through 30 days after the last dose of study drug; collected from 20 Jan 2014 to 04 Aug 2016. 2\) SAE's that had not resolved upon participants discontinuation were followed until recovered, recovered with sequelae, not recovered (death due to another cause) or death (due to the SAE); all AEs were assessed/monitored up to 132 weeks + 3 days

Additional Information

Anne McClain, Senior Manager, Clinical Trial Disclosure

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally sixty (60) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner
Publication restrictions are in place

Restriction type: OTHER