Trial Outcomes & Findings for A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma (NCT NCT03070964)

Last Updated: 2020-10-14

Results Overview

The study protocol established that the analysis of the primary endpoint should have been done once a total of 60 patients have received plitidepsin, with two futility analyses planned after the inclusion of approximately 15 and 30 patients, respectively. However, only a total of 14 patients were included, of whom 13 were treated, and 12 were evaluable for the primary efficacy endpoint (ORR per IRC in the "Per Protocol Patients" population). As a result of slow patient accrual, the study was closed before reaching the target enrollment of 15 patients for the first futility analysis, and the primary endpoint (ORR according to the Lugano classification criteria and per IRC) was not assessed.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Change from Baseline to assessments at: 1/2 weeks after cycle 3 and 4-8 weeks after cycle 6 (1cycle =28days), follow-up every 4 months +/- 2 weeks until progression disease or end of study (expected: 42 months)

Results posted on

2020-10-14

Participant Flow

The first IC was signed on 25Oct2016 and the first study treatment administration was on 9Nov2016. The cutoff date was 2Jul2018 (date of last follow-up, clinical cutoff). At cutoff date, 14 patients had been included, of whom 13 were treated and evaluable for safety, and 12 were evaluable for the primary efficacy endpoint

Participant milestones

Participant milestones
Measure	Plitidepsin Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Plitidepsin Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Overall Study Progressive disease	8
Overall Study Treatment-unrelated adverse event	2
Overall Study Never treated	1
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

A Study of Plitidepsin in Patients With Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plitidepsin n=14 Participants Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Age, Continuous	61 years n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Race/Ethnicity, Customized White	13 Participants n=99 Participants
Race/Ethnicity, Customized Hispanolatin	1 Participants n=99 Participants
ECOG PS PS 0	8 Participants n=99 Participants
ECOG PS PS 1	5 Participants n=99 Participants
ECOG PS PS 2	1 Participants n=99 Participants
Ann Arbor stage III	1 Participants n=99 Participants
Ann Arbor stage III-A	3 Participants n=99 Participants
Ann Arbor stage III-B	3 Participants n=99 Participants
Ann Arbor stage IV-A	3 Participants n=99 Participants
Ann Arbor stage IV-B	4 Participants n=99 Participants
Extranodal disease at diagnosis Yes	5 Participants n=99 Participants
Extranodal disease at diagnosis No	9 Participants n=99 Participants
Bulky lesion at diagnosis Yes	1 Participants n=99 Participants
Bulky lesion at diagnosis No	13 Participants n=99 Participants
International Prognostic Index score at diagnosis Low risk (0-1 risk factors)	2 Participants n=99 Participants
International Prognostic Index score at diagnosis Low-intermediate risk (2 risk factors)	2 Participants n=99 Participants
International Prognostic Index score at diagnosis High-intermediate risk (3 risk factors)	2 Participants n=99 Participants
International Prognostic Index score at diagnosis High risk (4-5 risk factors)	4 Participants n=99 Participants
International Prognostic Index score at diagnosis NA	4 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at diagnosis Group 1 (no adverse factors)	1 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at diagnosis Group 2 (1 risk factor)	1 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at diagnosis Group 4 (3-4 risk factors)	2 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at diagnosis NA	10 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at diagnosis Low-risk group	3 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at diagnosis High-risk group	3 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at diagnosis NA	8 Participants n=99 Participants
International prognostic index score at current disease Low risk (0-1 risk factors)	3 Participants n=99 Participants
International prognostic index score at current disease Low-intermediate risk (2 risk factors)	3 Participants n=99 Participants
International prognostic index score at current disease High-intermediate risk (3 risk factors)	4 Participants n=99 Participants
International prognostic index score at current disease High risk (4-5 risk factors)	4 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at current disease Group 1 (no adverse factors)	2 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at current disease Group 2 (1 risk factor)	3 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at current disease Group 3 (2 risk factors)	1 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at current disease Group 4 (3-4 risk factors)	1 Participants n=99 Participants
Prognostic index for peripheral T-cell lymphoma at current disease NA	7 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at current disease Low-risk group	5 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at current disease High-risk group	4 Participants n=99 Participants
Prognostic index for angioimmunoblastic T-cell lymphoma score at current disease NA	5 Participants n=99 Participants
Prior anticancer therapy lines 1 line	2 Participants n=99 Participants
Prior anticancer therapy lines 2 lines	5 Participants n=99 Participants
Prior anticancer therapy lines 3 lines	5 Participants n=99 Participants
Prior anticancer therapy lines 4 lines	1 Participants n=99 Participants
Prior anticancer therapy lines 5 lines	1 Participants n=99 Participants
Best response to last prior therapy CR	4 Participants n=99 Participants
Best response to last prior therapy PR	4 Participants n=99 Participants
Best response to last prior therapy SD	1 Participants n=99 Participants
Best response to last prior therapy PD	3 Participants n=99 Participants
Best response to last prior therapy UK	2 Participants n=99 Participants
Prior stem cell transplantation NO	8 Participants n=99 Participants
Prior stem cell transplantation Allogenic stem cell transplantation	1 Participants n=99 Participants
Prior stem cell transplantation Autologous stem cell transplantation	5 Participants n=99 Participants
Weight	72.5 Kg n=99 Participants
Height	166.5 cm n=99 Participants
Body Surface Area	1.8 m^2 n=99 Participants
Time from diagnosis to first plitidepsin infusion	24.1 months n=99 Participants
Time from last progressive disease to infusion	6.9 weeks n=99 Participants
Prior anticancer therapy lines	2.5 therapy lines n=99 Participants
Time to progressions to last anticancer therapy	4.6 months n=99 Participants

PRIMARY outcome

Timeframe: Change from Baseline to assessments at: 1/2 weeks after cycle 3 and 4-8 weeks after cycle 6 (1cycle =28days), follow-up every 4 months +/- 2 weeks until progression disease or end of study (expected: 42 months)

Population: Justification: The study was closed before reaching the target enrollment of 15 patients for the first futility analysis, and the primary endpoint (ORR according to the Lugano classification criteria and per IRC) was not assessed.

Outcome measures

Outcome measures
Measure	Plitidepsin n=12 Participants Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Overall Response Rate by the Lugano Classification Per Independent Review Assessment	NA Participants ORR according to the Lugano classification criteria per IRC was not assessed

SECONDARY outcome

Timeframe: From the date when the remission criteria are fulfilled to the first date when progressive disease, recurrence or death (due to any cause)is documented, expected at a maximum of 42 months

Population: A patient was never treated with plitidepsin. A patient due to lack of AITL diagnosis confirmation

CI, confidence interval; CR, complete response; NE, not evaluable; ORR, overall response rate; PD, disease progression; PR, partial response; SD, stable disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Plitidepsin n=12 Participants Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population CR	1 Participants
Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population PR	1 Participants
Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population SD	1 Participants
Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population PD	7 Participants
Overall Response Rate by Investigator's Assessment - Per Protocol Patients Population NE	2 Participants

Adverse Events

Plitidepsin

Serious events: 9 serious events

Other events: 13 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Plitidepsin n=13 participants at risk Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Vascular disorders Peripheral embolism	7.7% 1/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Alanine aminotransferase increased	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Cardiac disorders Cardiac arrest	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Cardiac disorders Cardiac failure	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Immune system disorders Anaphylactic reaction	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Blood and lymphatic system disorders Febrile neutropenia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Pyrexia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Pneumonia	7.7% 1/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Rhinovirus infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Septic shock	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Skin infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.

Other adverse events

Other adverse events
Measure	Plitidepsin n=13 participants at risk Plitidepsin was administered i.v. as a 1-hour infusion (fixed rate) via central or peripheral venous catheter. Patients received plitidepsin at a starting dose of 3.2 mg/m2 on Day 1, 8 and 15 every four weeks (q4wk). A 1-day window is allowed for plitidepsin administration. A cycle is defined as a fourweek period. A 1-day window was allowed for plitidepsin administration.
Vascular disorders Subclavian vein thrombosis	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Asthenia/Fatigue	30.8% 4/13 • Number of events 6 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Chills	7.7% 1/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Malaise	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Oedema peripheral	23.1% 3/13 • Number of events 3 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
General disorders Pyrexia	46.2% 6/13 • Number of events 17 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Injury, poisoning and procedural complications Limb injury	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Alanine aminotransferase increased	30.8% 4/13 • Number of events 15 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Blood creatine phosphokinase increased	7.7% 1/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Electrocardiogram QT prolonged	7.7% 1/13 • Number of events 6 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Weight decreased	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Anaemia	23.1% 3/13 • Number of events 13 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Eosinophilia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Lymphadenopathy	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Neutropenia	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Investigations Thrombocytopenia	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Cough	23.1% 3/13 • Number of events 3 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.4% 2/13 • Number of events 3 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Dizziness	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Dysaesthesia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Neuropathy peripheral	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Paraesthesia	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Nervous system disorders Transient ischaemic attack	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Abdominal pain	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Diarrhoea	38.5% 5/13 • Number of events 7 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Epigastric discomfort	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Flatulence	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Gastric mucosa erythema	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Melaena	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Nausea	46.2% 6/13 • Number of events 7 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Rectal haemorrhage	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Gastrointestinal disorders Vomiting	23.1% 3/13 • Number of events 4 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Renal and urinary disorders Renal failure	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Renal and urinary disorders Renal impairment	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Skin and subcutaneous tissue disorders Night sweats	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Skin and subcutaneous tissue disorders Pruritus	30.8% 4/13 • Number of events 5 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Skin and subcutaneous tissue disorders Rash	23.1% 3/13 • Number of events 8 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Skin and subcutaneous tissue disorders Rash macular	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Musculoskeletal and connective tissue disorders Joint swelling	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 1/13 • Number of events 3 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Musculoskeletal and connective tissue disorders Myopathy	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Metabolism and nutrition disorders Decreased appetite	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Metabolism and nutrition disorders Hypokalaemia	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Metabolism and nutrition disorders Hypomagnesaemia	15.4% 2/13 • Number of events 3 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Metabolism and nutrition disorders Hyponatraemia	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Candida infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Cytomegalovirus infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Herpes zoster	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Influenza	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Nasopharyngitis	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Pharyngitis	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Respiratory tract infection	15.4% 2/13 • Number of events 2 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Rhinovirus infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.
Infections and infestations Upper respiratory tract infection	7.7% 1/13 • Number of events 1 • Participants were assessed through study completion, approximately 2 years One patient was never treated with plitidepsin and was excluded from the analysis of safety.

Additional Information

Clinical Developtment, 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 The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER