Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Olaparib 150mg Tablet by SP Accure: After an overnight fast of at least 10.00 hours before scheduled time for dosing, single dose of Test product (T): Olaparib 150 mg Tablets (2x150mg)
Sponsors
Intercontinental Pharma
ICBio Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients on treatment with advanced metastatic breast cancer. 2) Patients that are already receiving a stable dose of olaparib tablets (2 x 150 mg tablets) 300 mg twice daily for at least 10 days. 3) Patients requiring Olaparib in the dose of 300 mg (2 x 150 mg tablets) twice daily as per the discretion of the Investigators, these patients will be stabilized on Olaparib as a part of study and those patients that tolerate Olaparib in the dose of 300 mg twice daily for 10 days will be randomized in the study. 4) Maintenance treatment of adult patients with advanced metastatic Breast cancer (adenocarcinoma) who are in complete or partial response to first line chemotherapy. 5) Patients have an estimated survival of at least 3 months. 6) Adult female subject of 18-60 years (both inclusive) of age. 7) Non-smoking, non-pregnant, non-lactating female patient with a body mass index in the range of 18. 50 30.00 kg/m2 (both inclusive). 8) Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study. 9) Willing to be available for the entire study period and to comply with protocol requirements. 10) Subjects with adequate laboratory values as determined at the time of eligibility assessment. 11) Patients with ECOG performance status of 0-2 (Attachment 01). 12) Patients with absence of blood transfusion in the 28 days prior to randomization. 13) Women of non-childbearing potential with documented evidence of hysterectomy/ bilateral salpingectomy/ bilateral oophorectomy at least 6 months prior to IMP administration) or postmenopausal for at least 12 consecutive months. Or 14) Women of child bearing potential must have negative Urine pregnancy test at screening visit and negative serum beta-hcG test during check-in and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to drug administration] sexual partner) for at least 4 weeks prior to drug administration, during the study and up to 6 months after the last dose of drug administration. Cessation of birth control after this point should be discussed with a responsible physician. 15) With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies. 16) Able to read and understand the Informed Consent Document as a whole and communicate effectively if required.
Exclusion criteria
Exclusion criteria: 1) History of known hypersensitivity to Olaparib or its components which in the opinion of the Investigator would compromise the safety of the patient or the results of the study. 2) Patients found positive for HIV Syphilis Hepatitis B surface antigen or Hepatitis C antibody at screening. 3) Have ongoing clinically significant adverse events due to prior treatments administered as determined by the Investigator. 4) History of other malignancies in the last five years. 5) Patients with Pneumonitis. 6) Patients with severe hepatic impairment Child Pugh classification category C. 7) Patients who received any chemotherapy radiotherapy or any other anticancer therapy within four weeks from the last dose prior to first dosing in Period 01 or a longer period depending on the defined characteristics of the agents used. 8) History or presence of any active infection or uncontrolled systemic disease for example cardiovascular disease hypertension diabetes mellitus etc or any clinically significant disease condition disorder or abnormal laboratory finding that in the opinion of the Investigator may either put the patient at risk because of participation in the study or influence the study results or the patient ability to participate in the study. 9) Patients had major surgery within four weeks prior to first dosing in Period 01 or who have not recovered from prior major surgery. 10) In the opinion of the Investigator the patient will not be compliant with the requirements of the study procedures. 11) Receipt of an investigational medicinal product or participation in another drug research study involving drug administration within thirty days prior to first dosing in Period 01 for the current study. 12) Usage of strong and moderate CYP3A4 inhibitors for example cimetidine ciprofloxacin grapefruit juice or strong and moderate CYP3A4 inducers for example carbamazepine phenytoin St Johns Wort rifampicin within thirty days prior to first dosing in Period 01 refer Attachment 02 for a full list of prohibited medications. 13) History of difficulty in accessibility of veins or intolerance to direct venipuncture. 14) Pregnant or lactating females. 15) Patient with positive test result on Breath alcohol analyzer test at the time of baseline or randomization visit. 16) Positive on urine test for drugs of abuse including amphetamines barbiturates benzodiazepines marijuana cocaine and morphine prior to receiving the first dose of investigational medicinal product in the study. 17) History or presence of alcoholism or drug abuse. 18) Patients with psychiatric illness or social situations that would limit compliance with study requirements. 19) Difficulty in swallowing tablets. 20) Patients having problems with fasting restriction. 21) History or presence of clinically significant lactose galactose or fructose intolerance. 22) Participated in any clinical investigation requiring repeated blood sampling blood donation or have blood loss of more than five hundred millilitres in past ninety days prior to dosing. 23) Participated in any clinical study within the past ninety days prior to first dosing. 24) Consumption of alcoho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the rate and extent of absorption of Olaparib 150 mg Tablets by SP Accure Labs Private Limited with Lynparza 150 mg Tablet (Olaparib) of AstraZeneca Pharmaceuticals LP., in female patients with advanced metastatic Breast cancer (adenocarcinoma) under fasting conditions.Timepoint: The venous blood samples will be withdrawn at pre-dose 0.00 hours on Day 1, 6, 7, 8, 14, 15 & 16 and 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 6.00, 9.00 and 12.00 hours post-dose following drug administration on Day 6, 7, 8, 14, 15 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of the study subjects after administration of Olaparib 150 mg Tablets in female patients with advanced metastatic Breast cancer (adenocarcinoma) under fasting conditions.Timepoint: At vital signs (blood pressure, pulse rate, respiratory rate and axillary/body temperature) measurement Before morning dose of Day 1, Day 6 to Day 9, and Day 14 to Day 16 (within 2.00 hrs before dosing), at 3.00 hours after morning dose on Day 6 to Day 9 and Day 14 to Day 16, End of the study Day 16 and Follow up on Day 24 2. The well-being of subjects will be ascertained at each vital sign measurement. | — |
Countries
India
Contacts
Public ContactDr Lakshmaiah KC
Srinivasam Cancer Care Multi-Speciality Hospital
Outcome results
None listed