Apollo Cancer Centre, Plot no, 251, Sainik School Rd, Bhubaneswar, Odisha

Inclusion Criteria

  • Subjects receiving olaparib for the following indications in ovarian cancer: for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
  • Subjects receiving olaparib for the following indication in breast cancer: in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.

Exclusion Criteria

  • Subjects with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug OR
  • Patients with a previously or currently diagnosed MDS/ AML or pneumonitis
  • Patients who have not recovered sufficiently from prior surgery or anticancer treatment OR
  • Patients who have known history of hepatitis B or hepatitis C OR
  • Patients with active infection such as TB

Inclusion Criteria

  • Male or female subjects aged >18 years of age.
  • Histologically confirmed, Grade 1-3a, previously untreated, CD20-positive, LTB-FL as per Groupe D’Etude des Lymphomes Follicularies (GELF) criteria. Subjects must have tissue available for the central pathology review and a centrally confirmed diagnosis prior to being randomised. Should a subject be eligible as per the central imaging review but not as per the study centre review the subject will be considered eligible if confirmed both by the Investigator and the Medical Monitor. For any other disagreement in eligibility the subject will be considered ineligible.
  • Ann Arbor Stage II to IV of histological Grade 1, 2, or 3a.

Exclusion Criteria

  • Prior use of rituximab or any CD20 mAb for any reason.
  • Any prior therapy for FL (including but not limited to chemotherapy, radiotherapy).
  • Evidence of histologic transformation to high grade lymphoma or DLBCL.
  • Subjects on chronic supra-substitutive doses (defined as doses in excess of 7.5mg per day of prednisone or prednisone equivalent for a period longer than 3 weeks) of systemic glucocorticoids

Inclusion Criteria

  • Female patient so f age 18 to 65 years (both inclusive).
  • Documented evidence of HER-2 over expression as described by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with Fish confirmation) or HER2 gene amplification by fluorescence in situ hybridization (FISH) (as defined by a ratio >2.0) or positive chromogenic in situ hybridization (CISH) result.
  • Patients who have received adjuvant radiotherapy as part of the treatment of early breast cancer are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomization.

Exclusion Criteria

  • Patients with history of severe hypersensitivity reaction to paclitaxel, or to any of the excipients.
  • Patients received prior chemotherapy for metastatic breast cancer. However, the following patients with prior chemotherapy will be allowed.
    • Neo –adjuvant antracycline 12 months prior to randomization is allowed.
    • Neo-adjuvant taxanes 12 months prior to randomization is allowed.
    • Neo-adjuvant trastuzumab or any other monoclonal antibody 12 months prior to randomization is allowed.
    • Hormonal therapy administered in neo-adjuvant setting only.
  • Patients receiving concurrent immunotherapy or hormonal therapy.

Inclusion Criteria

  • Female patients with >18 years of age, and premenopausal status, as confirmed by no irregularities in last three consecutive menstrual period or Serum Estrogen (E2) level that is in the premenopausal range.
  • IHC evidence of estrogen receptor positive (allred score of >3/8) and IHC or FISH evidence of negative cerb B2 status.
  • IHC or FISh evidence for negative Cerb B2 status.
    • In case of historical reports of IHC confirming evidence of ER-positive and Cerb B2 negative status, a repeat ICH is not required.

Exclusion Criteria

  • Patients with major surgery or any anti-cancer therapy within 2 weeks prior to enrolment.
  • History of prior invasive malignancy, except breast cancer or non-melanoma skin cancer.
  • Women in their post-menopausal state – a period of continuous absence of menstrual cycles for 12 months or more as calculated at the time of screening.
  • Known history of alcohol / drug abuse.

Inclusion Criteria

  • Histologically or cytologically confirmed adenocarcinoma of prostate.
  • Documented metastatic disease either by a positive bone scan, or soft tissue or visceral metastases, either by contrast–enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review.
  • Subjects with regional lymph node metastases only (N1, below the aortic bifurcation) will not be eligible for the study. Only subjects with non-regional lymph node metastases (M1a) and/or bone metastases (M1b) and/or other sites of metastases with or without bone disease (M1c) will be eligible.

Exclusion Criteria

  • Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate.
  • Known brain/ leptomeningeal metastases.
    • note: Brain CT/MRI scan should be performed only in case of symptoms
  • Prior treatment with:
    • LHRH agonist/antagonists started ≥ 12 weeks before study treatment starts except neoadjuvant and /or adjuvant therapy for a duration ≤ 24 months and completed ≥ 12 months prior to randomization
    • Second–generation androgen receptor inhibitors (ARi) such as enzalutamide, ARN–509, darolutamide, apalutamide other investigational AR inhibitors
    • Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
    • Chemotherapy including docetaxel or immunotherapy for prostate cancer

Inclusion Criteria

  • Willing and able to provide voluntary informed consent and to follow the protocol requirements.
  • Subjects aged 18-75 years (both inclusive) having Body Mass Index (BMI) at least 17.00 calculated where weight in kg and height in m2.
  • Subjects with confirmed diagnosis of advanced renal cell carcinoma includes,
  • a) Newly diagnosed subjects OR
  • b) Subjects who are already receiving stable dose of Pazopanib HCl tablets of 800 mg/day for at least 4 weeks OR
  • c) Subjects with failure of first line treatment for advanced renal cell carcinoma and as per investigator’s discretion are eligible to receive pazopanib HCl tablets.
  • Subject is able to swallow and retain oral medication

Exclusion Criteria

  • Known CNS metastasis.
  • History or presence of Thrombotic microangiopathy (TMA) or any other dermatological toxicity.
  • Subjects with ECOG Performance Status of > 2
  • Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
  • Surgical or other non-healing wounds.
  • A subject with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).

Inclusion Criteria

  • Has histological or cytological confirmed metastatic breast cancer after failure of combination chemotherapy for metastatic disease or has had a relapse within 6 months of adjuvant chemotherapy (Prior therapy should have included an anthracycline, such as doxorubicin, daunorubicin, mitoxantrone or other related compounds unless clinically contraindicated)
  • Age: 18 years or older but less than 70 years (both inclusive), Subject must meet age requirements at the time of signing the initial informed consent and the initial study medication administration.

Exclusion Criteria

  • Social Habits (for example):
  • a. Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication.
  • b. Ingestion of any caffeine- or xanthine-containing food or beverage within the 24 hours prior to the initial administration of study medication.
  • c. Any recent, significant change in dietary or exercise habits.
  • d. History of drug and/or alcohol abuse within one year of start of study.

Inclusion Criteria

  • Male or Female patients between 18 – 75 years of age (both inclusive)
  • Treatment naïve for :
    • mCRC with the exception of post-operative adjuvant chemotherapy completed at least 6 months prior to randomisation; or
    • locally advanced, recurrent or metastatic NSCLC; or
    • platinum sensitive recurrent epithelial ovarian cancer; or
    • persistent, recurrent, or metastatic carcinoma of the cervix

Exclusion Criteria

  • Evidence of bleeding diathesis or coagulopathy, any current anticoagulant or antiplatelet therapy; or any history of central nervous system haemorrhage; hemoptysis or conditions with major risk of bleeding such as oesophageal varices or tumour involvement of major blood vessels;
  • History of abdominal fistula, GI perforation, diverticulitis or intra-abdominal abscess within the six months before enrolment or any chronic gastrointestinal disease causing diarrhoea.