Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients (NCT NCT00711958)

NCT ID: NCT00711958

Last Updated: 2017-09-05

Results Overview

Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

114 participants

Primary outcome timeframe

5-12 weeks

Results posted on

2017-09-05

Participant Flow

23 cancer centers, in Germany and Romania .

2:1 randomization All 114 patients found eligible were randomized and treated (60 in Germany and 54 in Romania)

Participant milestones

Participant milestones
Measure	HX575 Epoetin Alfa Hexal AG HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin	ERYPO® Janssen-Cilag ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Overall Study STARTED	74	40
Overall Study COMPLETED	41	17
Overall Study NOT COMPLETED	33	23

Reasons for withdrawal

Reasons for withdrawal
Measure	HX575 Epoetin Alfa Hexal AG HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin	ERYPO® Janssen-Cilag ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Overall Study Withdrawal by Subject	6	8
Overall Study Lack of Efficacy	3	1
Overall Study Clinical deterioration	1	0
Overall Study Adverse Event	9	7
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Death	10	5
Overall Study Progression of disease	1	0

Baseline Characteristics

Study to Assess the Efficacy and Safety of HX575 in the Treatment of Chemotherapy Associated Anemia in Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HX575 Epoetin Alfa Hexal AG n=74 Participants HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin	ERYPO® Janssen-Cilag n=40 Participants ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa	Total n=114 Participants Total of all reporting groups
Age, Customized 18-39 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Customized 40-64 years	43 Participants n=5 Participants	18 Participants n=7 Participants	61 Participants n=5 Participants
Age, Customized ≥65 years	28 Participants n=5 Participants	19 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	17 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	23 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Romania	36 Participants n=5 Participants	18 Participants n=7 Participants	54 Participants n=5 Participants
Region of Enrollment Germany	38 Participants n=5 Participants	22 Participants n=7 Participants	60 Participants n=5 Participants
most frequent site of primary malignancy ovary	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
most frequent site of primary malignancy lung	13 Participants n=5 Participants	6 Participants n=7 Participants	19 Participants n=5 Participants
most frequent site of primary malignancy pancreas	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
most frequent site of primary malignancy stomach	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
most frequent site of primary malignancy breast	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
most frequent site of primary malignancy other	27 Participants n=5 Participants	16 Participants n=7 Participants	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5-12 weeks

Population: Intention-to-treat population: patients with post baseline Hemoglobin value available

Proportion of patients with a change in hemoglobin levels more than 2 g/dL under treatment with HX575, estimated between weeks 5-12.

Outcome measures

Outcome measures
Measure	HX575 Epoetin Alfa Hexal AG n=60 Participants HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin	ERYPO® Janssen-Cilag n=34 Participants ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Efficacy of HX575 in the Treatment of Chemotherapy Associated Anemia	37 Participants	15 Participants

Adverse Events

HX575 Epoetin Alfa Hexal AG

Serious events: 34 serious events

Other events: 62 other events

Deaths: 18 deaths

ERYPO® Janssen-Cilag

Serious events: 18 serious events

Other events: 30 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Biopharmaceutical Clinical Development, Strategic Planning

Sandoz

Phone: 0049 80244760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results stemming from the present trial can only be published if both the Coordinating investigator and the sponsor give their consent. Publications of subcollectives or center specific data are only possible if the whole study results have already been published.
Publication restrictions are in place

Restriction type: OTHER

Measure	HX575 Epoetin Alfa Hexal AG n=74 participants at risk HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. HX575, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin	ERYPO® Janssen-Cilag n=40 participants at risk ERYPO® Janssen-Cilag, Germany. Eligible patients were treated subcutaneously (solution for injection (s.c.)) with ERYPO® (Janssen-Cilag, Germany) in pre-filled syringes for 12 weeks.The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the therapeutic range. Application of the drug required at least once per week and allowed maximum three times per week. ERYPO®, Janssen-Cilag, solution for injection (s.c.): 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
Gastrointestinal disorders Nausea	23.0% 17/74 • Number of events 23 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	35.0% 14/40 • Number of events 25 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Gastrointestinal disorders Vomiting	17.6% 13/74 • Number of events 16 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	22.5% 9/40 • Number of events 15 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Gastrointestinal disorders Constipation	12.2% 9/74 • Number of events 13 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	15.0% 6/40 • Number of events 6 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Gastrointestinal disorders Abdominal pain	12.2% 9/74 • Number of events 10 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	12.5% 5/40 • Number of events 6 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Gastrointestinal disorders Diarrhoea	5.4% 4/74 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	10.0% 4/40 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Gastrointestinal disorders Abdominal pain upper	5.4% 4/74 • Number of events 4 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	7.5% 3/40 • Number of events 3 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
General disorders Asthenia	20.3% 15/74 • Number of events 21 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	15.0% 6/40 • Number of events 7 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
General disorders Pyrexia	12.2% 9/74 • Number of events 15 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	10.0% 4/40 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
General disorders Fatigue	6.8% 5/74 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	15.0% 6/40 • Number of events 6 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
General disorders Oedema peripheral	6.8% 5/74 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	10.0% 4/40 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Metabolism and nutrition disorders Anorexia	16.2% 12/74 • Number of events 16 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	17.5% 7/40 • Number of events 12 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.5% 7/74 • Number of events 7 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	7.5% 3/40 • Number of events 3 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Blood and lymphatic system disorders leukopenia	5.4% 4/74 • Number of events 6 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	7.5% 3/40 • Number of events 3 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Psychiatric disorders Anxiety	5.4% 4/74 • Number of events 5 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	7.5% 3/40 • Number of events 3 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration
Metabolism and nutrition disorders iron deficiency	8.1% 6/74 • Number of events 6 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration	0.00% 0/40 • 12 weeks Treatment emergent adverse events were collected, starting from the day of study medication administration