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

Pharma Mar

Status and phase: Completed; Phase 1

Conditions: Major Advanced Solid Tumors Other Than Colorectal

Treatments: Drug: PM01183

Study type: Interventional

Funder types: Industry

Identifiers

NCT01405391

PM1183-A-005-11

Details and patient eligibility

About

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

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily signed and dated written informed consent
2. Age ≥ 18 years.
3. Non or minimally daily activities-interfering disease related symptoms.
4. Life expectancy ≥ 3 months.
5. Patients with solid tumor other than CRC.
6. 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).
7. Normal cardiac function cardiac function by appropriate image testing.
8. Women of childbearing potential must have a negative serum pregnancy test before study entry.

Exclusion criteria

1. Primary colorectal cancer diagnosis

2. Prior treatment with PM01183.

3. 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.

4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases

5. 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.

6. History of extensive prior pelvic irradiation.

7. History of previous bone marrow and/or stem cell transplantation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

A

Experimental group

Description:

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.

Treatment:

Drug: PM01183