Trial Outcomes & Findings for Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment (NCT NCT03427268)
NCT ID: NCT03427268
Last Updated: 2021-05-24
Results Overview
Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months
Results posted on
2021-05-24
Participant Flow
The first informed consent was signed on 16 January 2018 and the first study treatment administration was on 8 February 2018. The cutoff date for the results was 11 February 2019 (date of last follow-up).
Participant milestones
| Measure |
PM060184
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
PM060184
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Overall Study
Progressive disease
|
25
|
|
Overall Study
Never treated
|
2
|
|
Overall Study
Compassionate use
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment
Baseline characteristics by cohort
| Measure |
PM060184
n=32 Participants
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
31 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
PS 0
|
15 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
PS 1
|
17 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage I
|
1 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage IIIB
|
5 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage IIIC
|
2 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage IV
|
17 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage IVA
|
3 Participants
n=5 Participants
|
|
Stage at diagnosis
Stage IVB
|
3 Participants
n=5 Participants
|
|
Stage at diagnosis
UK
|
1 Participants
n=5 Participants
|
|
Primary tumor side
Left
|
22 Participants
n=5 Participants
|
|
Primary tumor side
Right
|
10 Participants
n=5 Participants
|
|
Histology grade at diagnosis
G1: Well differentiated
|
8 Participants
n=5 Participants
|
|
Histology grade at diagnosis
G2: Moderately differentiated
|
18 Participants
n=5 Participants
|
|
Histology grade at diagnosis
G4: Undifferentiated
|
1 Participants
n=5 Participants
|
|
Histology grade at diagnosis
GX: Grade cannot be assessed
|
5 Participants
n=5 Participants
|
|
KRAS mutation status
Mutated
|
25 Participants
n=5 Participants
|
|
KRAS mutation status
Not done
|
6 Participants
n=5 Participants
|
|
KRAS mutation status
Unknown
|
1 Participants
n=5 Participants
|
|
Sites involved
1 site
|
5 Participants
n=5 Participants
|
|
Sites involved
2 sites
|
12 Participants
n=5 Participants
|
|
Sites involved
3 sites
|
8 Participants
n=5 Participants
|
|
Sites involved
4 sites
|
5 Participants
n=5 Participants
|
|
Sites involved
6 sites
|
1 Participants
n=5 Participants
|
|
Sites involved
7 sites
|
1 Participants
n=5 Participants
|
|
Peripheral neuropathy
Yes
|
19 Participants
n=5 Participants
|
|
Peripheral neuropathy
No
|
13 Participants
n=5 Participants
|
|
Prior surgery
Yes
|
28 Participants
n=5 Participants
|
|
Prior surgery
No
|
4 Participants
n=5 Participants
|
|
Prior radiotherapy
Concurrent
|
1 Participants
n=5 Participants
|
|
Prior radiotherapy
Palliative
|
4 Participants
n=5 Participants
|
|
Prior radiotherapy
No
|
27 Participants
n=5 Participants
|
|
Prior anticancer lines
1 line
|
1 Participants
n=5 Participants
|
|
Prior anticancer lines
2 lines
|
26 Participants
n=5 Participants
|
|
Prior anticancer lines
3 lines
|
5 Participants
n=5 Participants
|
|
Best response to last prior therapy
CR
|
2 Participants
n=5 Participants
|
|
Best response to last prior therapy
PR
|
3 Participants
n=5 Participants
|
|
Best response to last prior therapy
SD
|
14 Participants
n=5 Participants
|
|
Best response to last prior therapy
PD
|
9 Participants
n=5 Participants
|
|
Best response to last prior therapy
UK
|
4 Participants
n=5 Participants
|
|
Weight
|
67 Kg
n=5 Participants
|
|
Height
|
166 cm
n=5 Participants
|
|
Body surface area
|
1.8 m^2
n=5 Participants
|
|
Time from diagnosis of advanced disease to study entry
|
17.3 months
n=5 Participants
|
|
Time from first diagnosis to first PM060184 infusion
|
22.9 months
n=5 Participants
|
|
Time from prior last progression before study entry
|
1.2 months
n=5 Participants
|
|
Time from stop date of prior chemotherapy to study entry
|
1.8 months
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 monthsPopulation: 2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles.
Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
PM060184
n=29 Participants
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Progression-free Survival Rate at Three Months
|
20.7 percentage of participants
Interval 8.0 to 39.7
|
SECONDARY outcome
Timeframe: From the first day of treatment to the date of death or last contact, up to 12 monthsPopulation: 2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles
Overall Survival (OS), defined as the time from the first day of treatment to the date of death or last contact.
Outcome measures
| Measure |
PM060184
n=29 Participants
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Overall Survival (OS)
|
9.8 months
Interval 4.6 to
not reached
|
SECONDARY outcome
Timeframe: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 monthsPopulation: 2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles
Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
PM060184
n=29 Participants
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Progression Free Survival (PFS)
|
2.6 months
Interval 1.3 to 2.8
|
SECONDARY outcome
Timeframe: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 monthsPopulation: 2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles
Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.1. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors
Outcome measures
| Measure |
PM060184
n=29 Participants
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Overall Response Rate (ORR)
SD <3 months
|
9 Participants
|
|
Overall Response Rate (ORR)
SD ≥3 months
|
7 Participants
|
|
Overall Response Rate (ORR)
PD
|
13 Participants
|
Adverse Events
PM060184
Serious events: 6 serious events
Other events: 30 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
PM060184
n=30 participants at risk
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • Number of events 3 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
3/30 • Number of events 3 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Infections and infestations
Pneumonia pneumococcal
|
3.3%
1/30 • Number of events 1 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
Other adverse events
| Measure |
PM060184
n=30 participants at risk
PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).
|
|---|---|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
2/30 • Number of events 7 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Vascular disorders
Hypertension
|
6.7%
2/30 • Number of events 9 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Number of events 2 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
3/30 • Number of events 3 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Blood bilirubin increased
|
10.0%
3/30 • Number of events 5 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
2/30 • Number of events 2 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Platelet count decreased
|
6.7%
2/30 • Number of events 2 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Investigations
Weight decreased
|
10.0%
3/30 • Number of events 7 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Blood and lymphatic system disorders
Anaemia
|
23.3%
7/30 • Number of events 14 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
3/30 • Number of events 3 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Dysaesthesia
|
10.0%
3/30 • Number of events 10 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Dysgeusia
|
6.7%
2/30 • Number of events 4 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
3/30 • Number of events 9 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Neurotoxicity
|
6.7%
2/30 • Number of events 7 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Paraesthesia
|
46.7%
14/30 • Number of events 52 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
3/30 • Number of events 12 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
General disorders
Asthenia
|
73.3%
22/30 • Number of events 74 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
General disorders
Chest pain
|
6.7%
2/30 • Number of events 4 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
General disorders
Pyrexia
|
16.7%
5/30 • Number of events 10 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30 • Number of events 7 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30 • Number of events 9 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
2/30 • Number of events 2 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
20/30 • Number of events 66 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
5/30 • Number of events 15 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Constipation
|
63.3%
19/30 • Number of events 61 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Diarrhoea
|
36.7%
11/30 • Number of events 33 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Nausea
|
30.0%
9/30 • Number of events 23 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • Number of events 7 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.7%
14/30 • Number of events 54 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 11 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
5/30 • Number of events 13 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
2/30 • Number of events 6 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
10/30 • Number of events 26 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
|
Infections and infestations
Device related infection
|
6.7%
2/30 • Number of events 3 • Patients were assessed between study start date and study completion date, approximately 1 year
Patient excluded for analysis of safety: Two patients were never treated
|
Additional Information
Clinical Developtment, Department of PharmaMar´s Oncology, Business Unit.
Pharmamar, S.A.
Phone: 0034 91846 60 00
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