Ovarian CarcinomaPhase 1NCT00862355
Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
A Phase 1 study testing SPARC147609 and Reference147609 in people with Ovarian Carcinoma, run by Sun Pharma Advanced Research Company Limited at 1 site in India.
Trial summary
Bioequivalence study of SPARC147609 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- SPARC147609 and Reference147609
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for enrollment in the study:
- Availability of subject for the entire study period and willingness to adhere to protocol requirements.
- Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given).
- Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
- Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance.
- Informed consent form given in written form.
Who cannot join
- History or presence of significant:
- Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc.
- Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year.
- Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg.
- Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study.
Show all 12Show fewer
- Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
- Participation in another clinical trial within the preceding 90 days of study start
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg
- Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg
- Pulse rate below 60/min. or above 100/min
Trial locations and contacts
1 site in 1 country.
About this study
Bioequivalence study of SPARC147609
- Conditions
- Ovarian Carcinoma
- Being tested
- SPARC147609, Reference147609
- Keywords
- Carcinoma, Ovary, Carcinoma Ovary
- Medical subject headings
- Ovarian Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC147609Drug
IV infusion
Reference147609Drug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | SPARC147609 Receives: Drug: SPARC147609 |
| 2 | Active comparator | Reference147609 Receives: Drug: Reference147609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product
Measured: 2 cycles
Secondary outcomes (1)
Treatment emergent adverse events
Measured: 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862355
- Sponsor's protocol ID
- DOX_2I_1476_09
- Status last verified
- May 2019
- First submitted
- 13 Mar 2009
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.
PubMed 29995186
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00862355
- Acronym / sponsor ID
- DOX_2I_1476_09
- Conditions
- Ovarian Carcinoma
- Keywords
- Carcinoma, Ovary, Carcinoma Ovary
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bioequivalence study of SPARC147609
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPARC147609SPARC147609 |
| 2 | Active comparator | Drug: Reference147609Reference147609 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects meeting all of the following criteria will be considered for enrollment in the study:
Key exclusion criteria (12 listed)
- History or presence of significant:
- Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study.
- Participation in another clinical trial within the preceding 90 days of study start
- Subjects who have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARC147609IV infusion | Drug | 1 |
| Reference147609IV infusion | Drug | 2 |
Primary outcome
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product
Time frame: 2 cycles
1 secondary outcome
Treatment emergent adverse events
Time frame: 2 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 29995186Bhowmik S, Bhowmick S, Maiti K, Chakra A, Shahi P, Jain D, Rajamannar T. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil(R) or Caelyx(R) in advanced ovarian cancer. Cancer Chemother Pharmacol. 2018 Sep;82(3):521-532. doi: 10.1007/s00280-018-3643-3. Epub 2018 Jul 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPARC147609 and Reference147609 in people with Ovarian Carcinoma, run by Sun Pharma Advanced Research Company Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product (time frame: 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00862355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.