Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment

NCT03427268 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PM60184-B-002-17
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 5

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  From the first day of treatment to the date of death or last contact, up to 12 months

• Progression Free Survival (PFS)

  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 from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months

Study Arms (1)

PM060184

EXPERIMENTAL

PM060184

Drug: PM060184

Interventions

PM060184 DRUG

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).

PM060184

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily written informed consent, obtained before the beginning of any study-specific procedures.
• Age ≥ 18 years.
• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (5)

US017

Los Angeles, California, 90089-9181, United States

Location

CA001

Toronto, Ontario, ON M5G 2M9, Canada

Location

ES001

Barcelona, 08035, Spain

Location

ES009

Madrid, 28041, Spain

Location

ES002

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

plocabulin

Results Point of Contact

• Title: Clinical Developtment, Department of PharmaMar´s Oncology, Business Unit.
• Organization: Pharmamar, S.A.

clinicaltrials@pharmamar.com

0034 91846 60 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 9, 2018
• Study Start: January 16, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: May 24, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-04

Locations

ES (3); US (1); CA (1)