Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks

NCT01405391 | Completed Phase 1

• 1 other identifier: PM1183-A-005-11
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.

Conditions

Major Advanced Solid Tumors Other Than Colorectal

Keywords

Pharma Mar; PM01183; Non-Colorectal Cancer (non-CRC); Dose finding phase I

Outcome Measures

Primary Outcomes (1)

• Recommended dose (RD)

  To determine the recommended dose (RD) of PM01183 administered as a 1-hour infusion intravenously (i.v.) on Days 1 and 8 every three weeks (q3wk) in non-colorectal cancer (non-CRC) patients.

  From treatment onset to end of treatment

Secondary Outcomes (3)

• Pharmacokinetics (PK): The dose-exposure relationships for Cmax and area under the curve (AUC) will be evaluated.

  During the infusions administered on Day 1 of Cycles 1 and 3, with a schedule of 13 samples.

• Antitumor activity measured clinically and/or radiologically according to RECIST or by evaluation of tumor markers

  Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first.

• Pharmacogenomics (PGx) analysis: Number of tumour patient samples with identified and validated putative molecular markers associated with the clinical outcome of non-CRC patients treated with PM01183.

  At the end of the study (24 months)

Study Arms (1)

A

EXPERIMENTAL

Patients will receive PM01183 on Days 1 and 8 q3wk (three weeks = one treatment cycle) as an i.v. infusion, starting at 3.0 mg/day, flat dose (FD), over a minimum total volume of 100 ml dilution (on 5% glucose or 0.9% sodium chloride) via a central catheter or over a minimum total volume of 250 ml via a peripheral line, over one hour (at a fixed rate) and through a pump device.

Drug: PM01183

Interventions

PM01183 DRUG

PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths, 1 mg and 4 mg vials. Before use, the 1 mg and 4 mg vials should be reconstituted with 2 ml and 8 ml of water for injection respectively, to give a solution containing 0.5 mg/ml PM01183. For administration to patients as an i.v. infusion, reconstituted vials are diluted with glucose 50 mg/ml (5%) solution for infusion or sodium chloride 9 mg/ml (0.9%) solution for infusion.

A

Eligibility Criteria

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

You may qualify if:

• Voluntarily signed and dated written informed consent
• Age ≥ 18 years.
• Non or minimally daily activities-interfering disease related symptoms.
• Life expectancy ≥ 3 months.
• Patients with solid tumor other than CRC.
• Normal cardiac function cardiac function by appropriate image testing.
• Women of childbearing potential must have a negative serum pregnancy test before study entry.

You may not qualify if:

• Primary colorectal cancer diagnosis
• Prior treatment with PM01183.
• Concomitant diseases/conditions:
• a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol.
• Symptomatic and progressive or corticosteroid-requiring documented brain metastases
• Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding.
• History of extensive prior pelvic irradiation.
• History of previous bone marrow and/or stem cell transplantation.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (2)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Cancer Research Center. University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Fernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9.

  PMID: 33914350 DERIVED

MeSH Terms

Interventions

PM 01183

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 29, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

US (2)