Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors

NCT02533674 | Completed Phase 1 Results

• 2 other identifiers: PM60184-A-003-142014-002943-16
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 2

Brief Summary

Prospective, open-label, dose-ranging, uncontrolled phase I study with escalating doses of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. The study objectives are: To determine the MTD and the RD of PM060184 in combination with gemcitabine in selected patients with advanced solid tumors. To characterize the safety profile and feasibility of this combination in this study population. To characterize the pharmacokinetics of this combination and to detect major drug-drug PK interactions. To obtain preliminary information on the clinical antitumor activity of this combination.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities

  Dose-limiting toxicities were defined as: * Grade 4 neutropenia lasting \>3 days * Grade≥3 febrile neutropenia of any duration or neutropenic sepsis * Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion * Grade 4 ALT/AST increase, or grade 3 lasting \>7 days * Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP * Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities * Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs. * The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented

  From the start of treatment to the end of cycle one which are 3 weeks

Secondary Outcomes (1)

• Number of Participants With Clinical Benefit

  Every two cycles (every six weeks ± one week) until Cycle 4, and then every three cycles (every nine weeks ± one week) while on treatment, up to 2 years

Study Arms (1)

gemcitabine plus PM060184

EXPERIMENTAL

Drug: Gemcitabine plus PM060184

Interventions

Gemcitabine plus PM060184 DRUG

gemcitabine plus PM060184

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 prior to any specific study procedure.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 1 (see APPENDIX 1).
• Life expectancy ≥ 3 months.
• Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors that progressed to standard therapy or for whom no standard therapy exists:
• Breast cancer non-candidate for hormone therapy alone.
• Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas).
• Locally advanced or metastatic head and neck cancer.
• Non-small cell lung cancer (NSCLC).
• Germ cell tumors (GCTs).
• Biliary tract adenocarcinoma.
• Adenocarcinoma or carcinoma of unknown primary site (UKPS).
• Cervix carcinoma.
• Gastrointestinal stromal tumor (GIST).
• Urothelial cancer.

You may not qualify if:

• Concomitant diseases/conditions:
• History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year.
• Symptomatic arrhythmia or any uncontrolled arrhythmia requiring ongoing treatment.
• Known chronic active hepatitis or cirrhosis
• Known human immunodeficiency virus (HIV) infection.
• Current or prior history of grade ≥ 2 peripheral sensory and/or motor neuropathy.
• Prior treatment with oxaliplatin.
• Limitation of the patient's ability to comply with the treatment or follow-up protocol.
• Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
• Symptomatic, progressive or corticosteroids-requiring documented brain metastases or leptomeningeal disease involvement.
• 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.
• Patients who have had RT in more than 35% of the bone marrow.
• Treatment with any investigational product within 30 days before the first infusion.
• Prior treatment with PM060184.
• Prior treatment with gemcitabine-containing therapy for advanced disease (adjuvant therapy is allowed, provided not more than six cycles were administered and relapse occurred more than six months after the last drug administration), and/or:

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (2)

Unknown Facility

New York, New York, 10461, United States

Location

Unknown Facility

Madrid, Spain

Location

MeSH Terms

Interventions

Gemcitabine; plocabulin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

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

clinicaltrials@pharmamar.com

+34 918466000

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 27, 2015
• Study Start: December 12, 2014
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: June 11, 2021
• Results First Posted: May 13, 2021

Record last verified: 2021-05

Locations

US (1); ES (1)