Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks
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|ClinicalTrials.gov Identifier: NCT01405391|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : January 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Advanced Solid Tumors Other Than Colorectal||Drug: PM01183||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
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.
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.
- Recommended dose (RD) [ Time Frame: From treatment onset to end of treatment ]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.
- 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. ]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. ]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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405391
|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|