Health Condition 1: C61- Malignant neoplasm of prostate
Conditions
Interventions
Intervention1: TOL3022 manufactured by Tolmar, Inc.): Dosage:
Cohort 1: 240 mg /0.70 mL
Cohort 1a: 120mg/ 0.35 ml
Cohort 2: 480mg/ 1.3 ml
Cohort 3b: 360mg/ 1.0ml
Cohort 3a: Loading dose paradigm
Sponsors
Tolmar, Inc,
CBCC Global Research LLP
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for study entry, subjects must meet all of the following criteria during screening: 1. Must be able and willing to provide written informed consent prior to participation and comply with the study protocol and procedures. 2. Is a male patient with histologically confirmed carcinoma of the prostate who is a candidate for androgen deprivation therapy (except for neoadjuvant hormonal therapy). 3. Has an Eastern Cooperative Oncology Group (ECOG) score of two or less. 4. Has a serum testosterone level within the age-specific normal range. 5. Has a prostate-specific antigen (PSA) value of four nanograms per milliliter or higher. 6. Has a hemoglobin level of ten grams per deciliter or higher. 7. Has a life expectancy of at least twelve months.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if one or more of the following criteria are applicable during screening: 1. Has previously received or is currently receiving hormonal treatment for prostate cancer. 2. Has recently received, within three months prior to screening, or is currently receiving treatment with any drugs (prescription or over-the-counter) that modify the testosterone level. 3. Is currently being treated with a five alpha reductase inhibitor or has had prior use within the last six months. 4. Is a candidate for curative therapy, that is, radical prostatectomy or radiotherapy. 5. Has elevated serum alanine aminotransferase level three times the upper limit of normal or serum total bilirubin level one and a half times the upper limit of normal. 6. Has abnormal laboratory results which, in the judgment of the Investigator, would affect the subjectâ??s health or the outcome of the study. 7. Has a known or suspected hepatic symptomatic biliary disease. 8. Presents with significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, endocrine, hematological, neurological, psychological, or dermatological disorder, or an active infection. In addition, has any other condition such as excessive alcohol or drug abuse (based on subject reported history) that may interfere with study participation or influence the conclusion of the study as judged by the Investigator. 9. Has a current or medical history of congenital long QT syndrome, with a QTc of more than four hundred fifty milliseconds, or the presence of severe cardiovascular disease defined as having required cardiovascular surgery or the occurrence of incapacitating myocardial infarction within the past twelve months prior to study enrollment. 10. Has a history of severe asthma, defined as a need for daily treatment with oral or inhalation steroids to control the asthma, anaphylactic reactions, angioedema, angioneurotic edema, or Quinckeâ??s edema. 11. Has any known hypersensitivity to any component of TOL3022. 12. Is currently under treatment for any cancers, except for certain skin cancers, other than prostate cancer. 13. Has received an investigational drug within the last three months preceding the screening visit. 14. Has had a loss of three hundred fifty milliliters or more of blood within ninety days prior to receiving the investigational product of the current study. 15. Has a positive serology for hepatitis B, defined as hepatitis B surface antigen or hepatitis B core antibody, hepatitis C virus, or human immunodeficiency virus. Note: Subjects with a hepatitis B core antibody positive result can be enrolled only if a confirmatory negative test is obtained, suggestive of no active infection currently. 16. Has a mental incapacity or language barrier precluding adequate understanding or cooperation. 17. Male subjects sexually active with a female partner of childbearing potential who are not willing to use one of the following acceptable contraceptive methods from the time of initial screening until six months after receiving TOL3022: Simultaneous use of a condom and, for the female partner, a hormonal contraceptive such as oral, patch, depot injection, implant, vaginal ring, or intrauterine device, or a non-hormonal intrauterine device. Simultaneous use of a condom and, for the female partner, a diaphragm or c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the PK following a single SC injection of TOL3022 in subjects with advanced prostate cancerTimepoint: Day 1 Day 2 Day 4 Day 6 Day 8 Day 15 Day 22 Day 29 Day 43 Day 57 Day 71 Day 85 Day 99 Day 113 Day 141 Day 169 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess safety & tolerability following a single SC injection of TOL3022 in subjects with advanced prostate cancer To evaluate the PD following a single SC injection of TOL3022 in subjects with advanced prostate cancer Timepoint: Day 1 Day 2 Day 4 Day 6 Day 8 Day 15 Day 22 Day 29 Day 43 Day 57 Day 71 Day 85 Day 99 Day 113 Day 141 Day 169 | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research
Outcome results
None listed