A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors

Proacta

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: PR104

Study type

Interventional

Funder types

Industry

Identifiers

NCT01358227

PR104-1002

Details and patient eligibility

About

The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or more
Histologically confirmed malignancy for which no effective therapy exists
Measurable or evaluable disease
ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for definition of ECOG Performance Status 0 and 1
Ability to read, understand and provide written informed consent
If the subject is on systemic steroids, the dose of steroids must be stable for at least two weeks prior to the first dose of PR-104

Exclusion criteria

Licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study
Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens
Absolute neutrophil count of < 1.5 x 109/L
Platelet count of < 100 x 109/L
Hemoglobin level of < 90 g/L (or requiring a red blood cell transfusion to maintain hemoglobin > 90 g/L)
Serum bilirubin greater than the upper limit of normal
ALT and AST greater than 2.5 times the upper limit of normal
Serum creatinine less than 1.5 times upper limit of normal
Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) greater than 1.1 times the upper limit of normal range
Women who are pregnant, breast-feeding or planning to become pregnant during the study
Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication. See section 5.11 (Contraceptives) for definition of effective methods of contraception
Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during study participation, including uncontrolled infection or infection requiring a concomitant parenteral antibiotic
Plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy) while on study
Less than four weeks since major surgery
Known to be HIV positive, Hepatitis B sAg positive or Hepatitis C positive with abnormal liver function tests
No known contraindication to single doses of naproxen