Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Cabazitaxel-Fasting (T1): Participants will
receive 100 mg dose (2
tablet of 50 mg each)
plus Prednisone 10 mg
on Day 1 of Week 1 of
cycle 1 after an
overnight fast of at
least 10 hours
Sponsors
Jina Pharmaceuticals Inc
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and in this protocol and is willing to participate in the study. 2. Male or and female according to their chromosomal composition at birth. 3. Age of greater than or equal to 18 years completed years at the time of signing the informed consent.4 Participants with histopathologically cytologically confirmed following primary advanced solid tumours Breast cancer, Head and neck, Lung, Melanoma, Prostate for which cabazitaxel monotherapy is a viable treatment option. 5.Participants with advanced solid malignancies refractory to conventional treatment. 6 Participants eligible to receive cabazitaxel treatment in the judgment of Investigator. Note Previous treatment with cabazitaxel in any setting is allowed provided it has been completed at least 5 half-life prior to randomization and no clinically significant toxicities are expected. 7 Participant has recovered from adverse events baseline or less than or equal to CTCAE Grade 1 due to prior anticancer therapy, unless AE is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator. 8 Eastern Cooperative Oncology Group ECOG performance status less than or equal to 2. 9 Contraceptive per Barrier Requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies Is not a woman of childbearing potential WOCBP OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective with a failure rate of less than 1 percent per year, preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 72 days after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure noncompliance, recently initiated of the contraceptive method in relation to the first dose of the study intervention. A WOCBP agrees not to donate eggs ova, oocytes, freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception. A WOCBP must have a negative highly sensitive serum pregnancy at screening, and urine pregnancy test within 24 hours before the first dose of investigational intervention. If a urine test cannot be confirmed as negative e.g an ambiguous result, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are located in The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy. 10. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 months after the last dose of study intervention.Must agree not to plan to father a child or donate sperm for reproduction. PLUS, either of the following -Be abstinent from heterosexual intercourse as their preferr
Exclusion criteria
Exclusion criteria: Known allergies, hypersensitivity, or intolerance to the study interventions, or components excipients thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.2. Contraindications to the use of study intervention per local prescribing information and or lactose.3. Had major surgical procedure within 4 weeks before screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study. NOTE- Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator. 4. Presence of hepatitis B surface antigen BsAg or hepatitis B core antibody HBcAb at screening or within 3 months prior to first dose of investigational intervention. 5. Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention. NOTE-Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained. 6. Has known human immunodeficiency virus HIV seropositive status, or positive HIV antibody test at screening. For participants with unknown HIV status, HIV testing will be performed at screening unless prohibited by local regulations. 7. History of malignancy except cancer under study within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. Note- The time requirement for no evidence of disease recurrence for at least 3 years does not apply to the cancer under study for which a participant is enrolled in the study. The time requirement also does not apply to participants basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers who underwent successful definitive resection with no evidence of metastatic disease which is considered cured with minimal risk of recurrence. 8. Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol related liver disease, non alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilsons disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator. Known hepatic or biliary abnormalities with the exception of Gilberts syndrome or asymptomatic gallstones. 9. QTc greater than 450 msec for male participants or QTc greater than 470 msec for female participants or QTc greater than 480 msec in participants with bundle branch block. NOTE A- QTc is the QT interval corrected for heart rate according to Fridericias formula QTcF. It is either machine-read or manually over-read. NOTE B-If a single ECG shows a QTcF with an absolute value as defined above, 2 additional ECGs at intervals of approximately 3-5 min must be performed within 30 min after the initial ECG, and the average of these 3 consecutive results for QTc will be used to determine eligibility. 10. Participant with clinically signifi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the effect of food on the pharmacokinetic of the cabazitaxel lipid tablet formulation after single weekly dosing (100 mg), using different meal conditions (after fasting, after HFHC meal and after LFLC meal).Timepoint: Pre-dose (0.000 hour), 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 96.000, 120.000 and 168.000 | — |
Secondary
| Measure | Time frame |
|---|---|
| To further evaluate and compare the effect of food on the pharmacokinetic of the cabazitaxel lipid tablet formulation after single weekly dosing (100 mg), using different meal conditions (after fasting, after HFHC meal and after LFLC meal). To evaluate the safety and tolerability of the cabazitaxel lipid tablet formulation after single weekly dosing (100 mg), using different meal conditions (after fasting, after HFHC meal and after LFLC meal).Timepoint: Pre-dose (0.000 hour), 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 3.500, 4.000, 4.500, 5.000, 6.000, 8.000, 12.000, 16.000, 24.000, 48.000, 72.000, 96.000, 120.000 and 168.000 | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed