Trial Outcomes & Findings for Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia (NCT NCT00780143)

Last Updated: 2018-11-09

Results Overview

To determine the maximum tolerated dose (MTD) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Until disease progression or unacceptable toxicity

Results posted on

2018-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Aplidin® Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aplidin® Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Overall Study Progressive disease	1
Overall Study Toxicity	1
Overall Study Adverse Event	1

Baseline Characteristics

Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aplidin® n=3 Participants Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	3 participants n=99 Participants

PRIMARY outcome

Timeframe: Until disease progression or unacceptable toxicity

Population: The Máximum Tolerate Dose level was not reached

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Until disease progression or unacceptable toxicity

Population: The Dose Limiting Toxicity not occurred

To determine the dose limiting toxicity (DLT) of Plitidepsin (Aplidin®) when administered daily x 5 days with a fixed dose of Cytarabine for 5 days every four weeks in patients with relapsed/refractory leukemia.

Outcome measures

Outcome measures
Measure	Aplidin® n=3 Participants Plitidepsin in combination with Cytarabine in Patients With Relapsed/Refractory Leukemia Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Dose Limiting Toxicity	0 Participants

PRIMARY outcome

Timeframe: Until disease progression or unacceptable toxicity

Population: not enough efficacy data were retrieved

To determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.

Outcome measures

Outcome data not reported

Adverse Events

Aplidin®

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Aplidin® n=3 participants at risk Plitidepsin in combination with Cytarabine Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Blood and lymphatic system disorders Neutropenia	33.3% 1/3
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3
Cardiac disorders Tachycardia	33.3% 1/3
General disorders Pyrexia	33.3% 1/3
Immune system disorders Hypersensitivity	33.3% 1/3
Infections and infestations Sepsis	33.3% 1/3
Vascular disorders Hypotension	33.3% 1/3

Other adverse events

Other adverse events
Measure	Aplidin® n=3 participants at risk Plitidepsin in combination with Cytarabine Plitidepsin plus Cytarabine: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3
Gastrointestinal disorders Abdominal pain	33.3% 1/3
Gastrointestinal disorders Diarrhoea	33.3% 1/3
Gastrointestinal disorders Dyspepsia	33.3% 1/3
Gastrointestinal disorders Gingival pain	33.3% 1/3
General disorders Asthenia	33.3% 1/3
General disorders Oedema	33.3% 1/3
General disorders Tenderness	33.3% 1/3
Infections and infestations Sinusitis	33.3% 1/3
Investigations Blood alkaline phosphatase increased	33.3% 1/3
Investigations Weight decreased	33.3% 1/3
Metabolism and nutrition disorders Anorexia	33.3% 1/3
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3
Renal and urinary disorders Nocturia	33.3% 1/3
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	33.3% 1/3
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3
Skin and subcutaneous tissue disorders Hyperhidrosis	33.3% 1/3
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3
Vascular disorders Venous stasis	33.3% 1/3

Additional Information

Clinical Development Department of PharmaMar´s Oncology,Business Unit.,

Pharma Mar, S.A.

Phone: +34 918466000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60