Advanced Colorectal CancerPhase 2NCT03427268
Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment
A Phase 2 study testing PM060184 in people with Advanced Colorectal Cancer, run by PharmaMar at 5 sites in 3 countries.
Trial summary
This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- PM060184
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 16 Jan 2018to 11 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily written informed consent, obtained before the beginning of any study-specific procedures.
- Age ≥ 18 years.
- Histologically-cytologically documented adenocarcinoma of colon or rectum that has progressed to the last prior treatment before inclusion.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. If the only tumor lesion is situated in a previously irradiated area or in an area subjected to other loco-regional therapy, regression in the lesion must be demonstrated radiologically.
- Previous treatment in any setting with fluoropyrimidine, oxaliplatin and irinotecan in any combination (unless any is contraindicated).
- Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred during or within six months of completion of such therapies.
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- Cumulative dose of prior oxaliplatin (if any) must be known.
- Prior cetuximab, panitumumab, bevacizumab, aflibercept, and regorafenib are allowed.
- No more than two prior therapies for metastatic disease.
- Washout periods for prior therapies (defined in relation to planned start of study treatment [first dose administration]):
- At least three weeks since the last administration of an antineoplastic treatment (chemotherapy, biological, targeted or investigational therapies).
- At least three weeks since radiotherapy involving up to 35% of bone marrow (radiotherapy involving > 35% of bone marrow is not allowed) or two weeks since the end of palliative radiotherapy including single doses.
- At least four weeks since any major surgical procedure, open biopsy, or significant traumatic injury.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Life expectancy ≥ 3 months.
- Adequate bone marrow, liver, and kidney function:
- Hemoglobin ≥ 9 g/dL.
- Absolute neutrophil count ≥ 1.5 × 109/L.
- Platelet count ≥ 100 × 109/L.
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula).
- Albumin ≥ 2.5 g/dL.
- Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in case of Gilbert syndrome.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5.0 × ULN in the case of liver metastases).
- Recovery to grade ≤ 1 from any toxicity due to previous therapy (including peripheral sensory/motor neuropathy but excluding alopecia).
- Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to institutional standards).
- Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure during the trial and up to six months after treatment discontinuation, and fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and up to four months after treatment discontinuation.
Who cannot join
- Prior exposure to PM060184.
- Known hypersensitivity to the study drug class or study drug excipient in the formulation.
- Patients with locally advanced disease amenable to local and/or curative therapy (surgery or radiotherapy) at study entry.
- Other serious and/or relevant diseases or clinical situations that, in the opinion of the Investigator, are incompatible with the protocol (including any of the following):
- History of another neoplastic disease (except for basal cell carcinoma of the skin, superficial bladder tumors, or properly treated carcinoma in situ of the uterine cervix or melanoma in situ) unless in remission for at least five years and with no recurrence.
- Symptomatic cerebral and/or leptomeningeal metastasis, spinal cord compression or carcinomatous meningitis.
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- Neuropathy of any etiology (other than that caused by previous antineoplastic therapy).
- History of cardiac disease, such as myocardial infarction, in the year prior to registration in the clinical trial; symptomatic/uncontrolled angina pectoris; congestive heart failure or uncontrolled cardiac ischemia; any type of uncontrolled arrhythmia, congenital and/or prolonged QT interval or abnormal LVEF, or uncontrolled arterial hypertension (according to the standards of the World Health Organization [WHO]).
- History of significant psychiatric disease.
- Active infection requiring antibiotic, antifungal or antiviral treatment that, in the opinion of the Investigator, could compromise the patient's capacity to tolerate the therapy.
- Known active liver (hepatitis B or C or cirrhosis) or renal disease.
- Known human immunodeficiency virus (HIV) infection.
- Any other concomitant pathology that could jeopardize the patient's safety or commitment to complete the clinical trial.
- Inability or refusal to comply with the protocol or with the clinical trial procedures.
- Pregnancy or lactation.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
About this study
Official title: A Phase II, Open-label, Multicentre Study of PM060184 in Patients With Advanced Colorectal Cancer After Standard Treatment.
This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and oxaliplatin).
Patients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute intravenous (i.v.) infusion on Days 1 and 8 q3wk.
- Conditions
- Advanced Colorectal Cancer
- Being tested
- PM060184
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PM060184Drug
PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point.
PM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle).
| Study group | Role | What they receive |
|---|---|---|
| PM060184 | Experimental | PM060184 Receives: Drug: PM060184 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate at Three Months
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
Measured: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months
Secondary outcomes (3)
Overall Survival (OS)
Overall Survival (OS), defined as the time from the first day of treatment to the date of death or last contact.
Measured: From the first day of treatment to the date of death or last contact, up to 12 months
Progression Free Survival (PFS)
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.
Measured: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months
Overall Response Rate (ORR)
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
Measured: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start16 Jan 2018
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaMar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427268
- Sponsor's protocol ID
- PM60184-B-002-17
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2017
- Last updated
- 24 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Multicentre Study of PM060184 in Patients With Advanced Colorectal Cancer After Standard Treatment.
- ClinicalTrials.gov ID
- NCT03427268
- Acronym / sponsor ID
- PM60184-B-002-17
- Conditions
- Advanced Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PharmaMarIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 9 Feb 2018 (actual)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and oxaliplatin).
Patients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute intravenous (i.v.) infusion on Days 1 and 8 q3wk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PM060184 | Experimental | Drug: PM060184PM060184 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Voluntarily written informed consent, obtained before the beginning of any study-specific procedures.
- Age ≥ 18 years.
- Histologically-cytologically documented adenocarcinoma of colon or rectum that has progressed to the last prior treatment before inclusion.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. If the only tumor lesion is situated in a previously irradiated area or in an area subjected to other loco-regional therapy, regression in the lesion must be demonstrated radiologically.
- Previous treatment in any setting with fluoropyrimidine, oxaliplatin and irinotecan in any combination (unless any is contraindicated).
Key exclusion criteria (15 listed)
- Prior exposure to PM060184.
- Known hypersensitivity to the study drug class or study drug excipient in the formulation.
- Patients with locally advanced disease amenable to local and/or curative therapy (surgery or radiotherapy) at study entry.
- Other serious and/or relevant diseases or clinical situations that, in the opinion of the Investigator, are incompatible with the protocol (including any of the following):
- Pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PM060184PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point. PM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle). | Drug | PM060184 |
Primary outcome
Progression-free Survival Rate at Three Months
Time frame: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months
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
3 secondary outcomes
Overall Survival (OS)
Time frame: From the first day of treatment to the date of death or last contact, up to 12 months
Progression Free Survival (PFS)
Time frame: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months
Overall Response Rate (ORR)
Time frame: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PM060184 in people with Advanced Colorectal Cancer, run by PharmaMar at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival Rate at Three Months (time frame: Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.