Bioequivalence study of Olaparib Tablets 150 mg

Not Applicable

Completed

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: C259- Malignant neoplasm of pancreas, unspecifiedHealth Condition 3: C61- Malignant neoplasm of prostateHealth Condition 4: C569- Malignant neoplasm of unspecifiedovary

• Registration Number: CTRI/2023/01/048868
• Lead Sponsor: Cipla Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-02
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

1. Adult patients with,

a) deleterious or suspected deleterious germline or somatic BRCA-mutated

advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are

in complete or partial response to first-line platinum-based chemotherapy. OR

b) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are

in complete or partial response to first-line platinum-based chemotherapy and

whose cancer is associated with homologous recombination deficiency (HRD)-

positive status defined by either: a deleterious or suspected deleterious BRCA

mutation, and/or genomic instability (study drug will be given in combination

with bevacizumab). OR

c) recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are

in complete or partial response to platinum-based chemotherapy. OR

d) deleterious or suspected deleterious gBRCAm human epidermal growth factor

receptor 2 (HER2)-negative high risk early breast cancer who have been treated

with neoadjuvant or adjuvant chemotherapy. OR

e) deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast

cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or

metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered

inappropriate for endocrine therapy. OR

f) deleterious or suspected deleterious gBRCAm metastatic pancreatic

adenocarcinoma whose disease has not progressed on at least 16 weeks of a first line platinum-based chemotherapy regimen. OR

g) deleterious or suspected deleterious germline or somatic homologous

recombination repair (HRR) gene-mutated metastatic castration-resistant

prostate cancer (mCRPC) who have progressed following prior treatment with

enzalutamide or abiraterone. OR

h) BRCA 1/2 wild type or unknown status ovarian cancer and are eligible to take

Olaparib for maintenance therapy as per PI discretion (NCCN Guidelines®-

Ovarian Cancer).

2. Patients with established dosing regimen for at least 14 days who already are

receiving a stable dose of Olaparib Tablet,. (2x150 mg tablets) 300 mg twice daily)

OR patients not stabilized on Olaparib/ Olaparib Treatment naïve patients who are

eligible to take Olaparib tablet, 150 mg for dose stabilization as per PI discretion.

3. Eastern Cooperative Oncology Group performance status of 0 or 1.

4. Adequate bone marrow function: ANC greater than or equal to 1,500 mm cubed;

Platelets count greater than or equal to 100,000 mm cubed; Hgb greater than or

equal to 9 g per dL.

5. Adequate renal function as determined by creatinine clearance greater than or equal

to 60 mL per min calculated by Cockcroft-Gault formula.

6. Adequate hepatic function: total bilirubin less than or equal to 1.5 times the upper

limit of normal; AST and ALT less than or equal to 2.5 times the upper limit of

normal (= 4 X ULN for liver metastasis); ALP less than 2 times the upper limit of

normal (= 5 X ULN for bone metastasis and prostate cancer).

7. Patients at least 18 to 65 years (both inclusive) of age at the time of screening.

8. Women of childbearing potential must have a negativ

Exclusion Criteria

1. Female Patients: Lactating or actively breastfeeding.

2. Patients who have participated in a clinical trial and received investigational drug within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product, whichever is longer, prior to randomization in this study.

3. Patients who have participated in a study that resulted in or made a donation of blood within 90 days prior to receiving the first dose of investigational medicinal product for the current study.

4. Patients with certain heart problems or history of bleeding within a month prior to screening.

5. Prostate cancer patients with history of Venous thromboembolic events within 2 months prior to screening

6. Patients with known Human Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus infection, COVID-19 and drugs of abuse or urine alcohol test.

7. Patients with a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study treatment or excipients.

8. Patients with any serious and/or unstable pre-existing medical disorder aside from malignancy explained above, psychiatric disorder, or other conditions that could interfere with patient’s safety, obtaining informed consent or compliance to the study procedures.

9. Patients with symptomatic or untreated leptomeningeal or brain metastases, or spinal cord compression. Patients with history of Myelodysplastic Syndrome or Acute Myeloid Leukemia

10. Patients with history of pneumonitis within 2 months prior to screening

11. Patients with history or current evidence of cardiovascular risk including any of the following: clinically significant uncontrolled arrhythmias, acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization, Class II congestive heart failure as defined by New York Heart Association (NYHA), treatment-refractory hypertension defined as a blood pressure of systolic blood pressure (SBP) >140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) >90 mmHg which cannot be controlled by anti-hypertensive therapy, has an intra-cardiac defibrillator or permanent pacemaker and known cardiac metastases.

12. Patients with any significant medical comorbidities or intercurrent illnesses that could limit compliance with study medications or increase the risk of treatment related toxicities

13. Known history of presence of Alcohol abuse or dependence within one year prior to first dose of drug administration or Drug abuse or dependence;

14. Patients with a history of any other malignancy apart from ovarian, breast, pancreatic or prostate malignancy. Patients who have been malignant disease-free for 3 years or patients with a history of a completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible.

15. Concomitant use of CYP3A inhibitors and CYP3A inducers

Study & Design

• Study Type: BA/BE
• Study Design: Not specified