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

Purpose

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

Condition	Intervention	Phase
Major Advanced Solid Tumors Other Than Colorectal	Drug: PM01183	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by PharmaMar:

Primary Outcome Measures:

Recommended dose (RD) [ Time Frame: From treatment onset to end of treatment ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Pharmacokinetics (PK): The dose-exposure relationships for Cmax and area under the curve (AUC) will be evaluated. [ Time Frame: During the infusions administered on Day 1 of Cycles 1 and 3, with a schedule of 13 samples. ] [ Designated as safety issue: No ]
To characterize the pharmacokinetics (PK) of this schedule and explore factors that may affect individual variability in main PK parameters.
Antitumor activity measured clinically and/or radiologically according to RECIST or by evaluation of tumor markers [ Time Frame: 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. ] [ Designated as safety issue: No ]
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments.
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. [ Time Frame: At the end of the study (24 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A 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 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.

Arms

Assigned Interventions

Experimental: A

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

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.

Detailed Description:

Phase I Study of PM01183 in Non-Colorectal (non-CRC) Cancer Patients to determine the recommended dose (RD) of PM01183, to characterize the safety profile, compliance and feasibility of the schedule, to optimize and individualize PM01183 dosing in non-CRC patients according to individual tolerance, to characterize the pharmacokinetics (PK) of the schedule, to obtain preliminary information on the clinical antitumor activity and to perform an exploratory pharmacogenomics (PGx) analysis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.
Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
Normal cardiac function cardiac function by appropriate image testing.
Women of childbearing potential must have a negative serum pregnancy test before study entry.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405391

Locations

United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Illinois
Cancer Research Center. University of Chicago Hospitals
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

PharmaMar

More Information

No publications provided

Responsible Party:	PharmaMar
ClinicalTrials.gov Identifier:	NCT01405391 History of Changes
Other Study ID Numbers:	PM1183-A-005-11
Study First Received:	July 26, 2011
Last Updated:	September 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by PharmaMar:

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

ClinicalTrials.gov processed this record on May 16, 2013