CTRI

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CTRI Number

CTRI/2026/04/109441 [Registered on: 27/04/2026] Trial Registered Prospectively

Last Modified On:

24/04/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A Phase II open-label clinical trial for Oseltamivir in Platinum Refractory Ovarian Cancer.

Scientific Title of Study

Oseltamivir in Platinum Refractory Ovarian Cancer: Mathematical Modelling Integration for Systemic Therapy (PROMMIS)

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Babita Kataria
Designation	Assistant Professor
Affiliation	National Cancer Institute campus, All India Institute of Medical Sciences, New Delhi
Address	Department of medical oncology, Room 121, Ist floor, Academic block, NCI-AIIMS,Jhajjar, Haryana- 124105 Jhajjar HARYANA 124105 India Jhajjar HARYANA 124105 India
Phone	7988976438
Fax
Email	dr.babita.lhmc@gmail.com

Details of Contact Person
Scientific Query

Name	Babita Kataria
Designation	Assistant Professor
Affiliation	National Cancer Institute campus, All India Institute of Medical Sciences, New Delhi
Address	Department of medical oncology, Room 121, Ist floor, Academic block, NCI-AIIMS,Jhajjar, Haryana- 124105 Jhajjar HARYANA 124105 India HARYANA 124105 India
Phone	7988976438
Fax
Email	dr.babita.lhmc@gmail.com

Details of Contact Person
Public Query

Name	Babita Kataria
Designation	Assistant Professor
Affiliation	National Cancer Institute campus, All India Institute of Medical Sciences, New Delhi
Address	Department of medical oncology, Room 121, Ist floor, Academic block, NCI-AIIMS,Jhajjar, Haryana- 124105 Jhajjar HARYANA 124105 India HARYANA 124105 India
Phone	7988976438
Fax
Email	dr.babita.lhmc@gmail.com

Source of Monetary or Material Support

Grant from an international Foundation "Cures within Reach"

Primary Sponsor

Name	All India Institute of Medical Sciences, Delhi
Address	Ansari Nagar East,New Delhi- 110029, India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Raja Pramanik	Dr. B.R.A.I.R.C.H.	Room 1 and 2, Ground floor, Medical Oncology OPD,Dr. B.R.A.I.R.C.H.,AIIMS, New Delhi-110029 New Delhi DELHI South DELHI	9654976088 dr_rajapramanik14@rediffmail.com
Dr Babita Kataria	NCI-AIIMS Jhajjar	B wing OPD, Third floor, OPD Block, Department of medical Oncology OPD, NCI-AIIMS,Badsa,Jhajjar,Haryana- 124105 Jhajjar HARYANA Jhajjar HARYANA	7988976438 dr.babita.lhmc@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
All India Institute of Medical Sciences	Approved
All India Institute of Medical Sciences	Submittted/Under Review

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: C569\|\|Malignant neoplasm of unspecifiedovary,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Oseltamivir	Tab. Oseltamivir 75 mg PO OD for 12 weeks in combination with Standard of care physicians choice of chemotherapy
Comparator Agent	Standard of care	Physicians choice of chemotherapy

Inclusion Criteria

Age From	18.00 Year(s)
Age To	99.00 Year(s)
Gender	Female
Details	Be willing and able to provide written informed consent for the trial, with a cytopathological or histopathological proven Epithelial Ovarian cancer, have recurrent or metastatic or unresectable disease not amenable to curative intent treatment, Have received and progressed on at least 1 line of anti-cancer treatment in a palliative setting and have either exhausted the standard of care treatment options in second line and beyond, or are unable to afford them, Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2, Demonstrate adequate organ function. In case of reproductive age group females, the last menstrual period is to be documented, and a urine pregnancy test is to be done to rule out pregnancy, if the uterus and ovaries are intact

ExclusionCriteria

Details

Patients with more than one active malignancy or a history of other invasive cancer within the last
5 years, Has an active infection requiring systemic therapy, Has a clinically significant co-morbid condition that might preclude a patient from receiving the
intervention treatment, including but not limited to significant cardio-vascular disease, such as
history of myocardial infarction, acute coronary syndrome or coronary
angioplasty, stenting, bypass grafting within the last 6 months. Congestive heart failure,
New York Heart Association Class II-IV, or history of CHF, NYHA class III or IV,
Respiratory illness like Chronic Obstructive airway disease or Interstitial lung disease
, uncontrolled diabetes mellitus, uncontrolled hypertension, residual grade II or more
toxicity per National Cancer Institute - Common Terminology Criteria for Adverse Events
v6.0, grade II or more peripheral neuropathy from previous treatments, etc., HIV positive patients not on antiretroviral therapy, Has known psychiatric or substance abuse disorders that would interfere with cooperation with
the requirements of the trial, Has a known hypersensitivity to the components of the study therapy or its analogues, Is pregnant or lactating, unless willing to go for medical termination of pregnancy and stop
lactation respectively.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
12-week Disease Control Rate	12-week from the date of randomization

Secondary Outcome

Outcome

TimePoints

1). Median Progression-free Survival (PFS)
End-point Definition: PFS is the time of progression/death from randomization.
Outcome measure: Log-rank test will be used to estimate median PFS.
2) Median Overall Survival (OS)
End-point definition: OS is the time of death from randomization. Patients will be censored on the data-cut-off date.
Outcome measure: Log-rank test will be used to estimate the median OS.
3). Assessment of Toxicities in the intervention arm:
Definition & outcome measure: National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) v6.0
will be used to define & grade the toxicities.

median PFS & median OS will be estomated when 50% of enrolled subjects would have progressed/ died respecxtively. Toxicity assessment will continue till 30 days after the last dose of intervention drug administration.

Target Sample Size

Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 2

Date of First Enrollment (India)

08/05/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Ovarian cancer is the third most common cancer in Indian females. Population-based cancer registry in India shows that almost 60-

70% of patients with ovarian cancer in India present with locally advanced disease with a 5-year survival of only 25%. Once ovarian

cancer becomes resistant to platinum-based chemotherapy, survival is usually less than a year.

Newer targeted therapies have changed current treatment standards for ovarian cancer in the developed world. Still, they are

inaccessible to most patients in low and middle-income countries (LMICs) because of the cost.

There is an unmet need to develop cost-effective, indigenous, innovative solutions to improve the survival of our cancer patients that

are accessible and affordable in LMICs.

Our collaborators at the Translational Health Sciences and Technology Institute (THSTI), India, have used publically available data on

ovarian cancer cells’ metabolic features to develop a mathematical model to predict possible drugs (approved for other indications)

with anti-cancer properties. Oseltamivir is one such option predicted by their model, and it has been validated in the lab for

platinum-resistant ovarian cancer cells by our collaborators at the Indian Institute of Science (IISc), India.

Oseltamivir is a very low-cost drug that has already been tested for safety in humans and approved for Influenza. We now want to

conduct a phase II single-arm study to test whether combining it with regular chemotherapy drugs used in platinum-resistant

ovarian cancer patients has the potential to improve their response to chemotherapy.

If our study is positive, we will conduct a larger trial to confirm our findings. We will also use the same approach to develop models

and find new low-cost options for other cancers.