A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factor

Genmab A/S0 sites25 target enrollmentFebruary 24, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cancer of the ovary, cervix, endometrium, bladder, prostate (castrationresistant prostate cancer [CRPC]), esophagus, lung (non-small cell lung cancer [NSCLC]), and Squamous cell carcinoma of the head and neck (SCCHN)
Sponsor: Genmab A/S
Enrollment: 25
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

February 24, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Patients must have completed one of the base trials and have shown a clinical benefit of stable disease or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or not completed treatment as defined in the base protocol for reasons that are not considered critical and unmanageable for the safety of the patient (as evaluated by the investigator and/or the sponsor) and the patient clearly showed response of Partial Response or better.
•\- Patients must not have experienced disease progression or unmanageable toxicity.
•\- Patients must not have received any other anti\-cancer treatment since the base trial.
•\- Investigator’s assessment that the benefit of continued tisotumab vedotin therapy will outweigh the risks.
•\- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\.
•\- A negative serum pregnancy test (if female and aged between 18\-55 years old).
•\- Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of tisotumab vedotin.
•\- Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial\-related activity is carried out.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\- Therapeutic anti\-coagulative or long\-term anti\-platelet treatment (use of low dose acetylsalicylic acid \[ASA] up to 81 mg/day and non\-ASA nonsteroidal anti inflammatory drugs is allowed).
•\- Presence of CTCAE (Common Toxicity Criteria for Adverse Events) grade \= 2 peripheral neuropathy.
•\- Clinically significant active viral, bacterial or fungal infection requiring intravenous treatment with anti\-infective therapy that has been administered less than two weeks prior to first dose in this trial, or oral treatment with anti\-infective therapy that has been administered less than one week prior to first dose in this trial; prophylactic anti\-infective therapy which is given without clinical symptoms is allowed.
•\- Ongoing acute or chronic inflammatory skin disease.
•\- Women who are pregnant or breast feeding.