Breast Cancer and Ovarian CancerPhase 1NCT03055143
Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer
A Phase 1 study testing SPARC-08-038 and Ref-08-038 in people with Breast Cancer and Ovarian Cancer, run by Sun Pharma Advanced Research Company Limited.
Trial summary
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer and Ovarian Cancer
- What is being tested?
- SPARC-08-038 and Ref-08-038
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2008to 28 Nov 2009
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
- Subjects who had no evidence of underlying disease
- Subjects who had signed written consent form
Who cannot join
- Females who were pregnant, breastfeeding, or are likely to become pregnant
- Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
- Subjects deemed uncooperative or noncompliant
- Smoking or consumption of any nicotine products
About this study
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
- Conditions
- Breast Cancer and Ovarian Cancer
- Being tested
- SPARC-08-038, Ref-08-038
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC-08-038Drug
2 mg/ml intravenous infusion
Ref-08-038Drug
2 mg/ml intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SPARC-08-038 | Experimental | 2 mg/ml Receives: Drug: SPARC-08-038; Drug: Ref-08-038 |
| Ref-08-038 | Active comparator | Not described Receives: Drug: SPARC-08-038; Drug: Ref-08-038 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured plasma concentration
Measured: 336 hours
Secondary outcomes (1)
The area under the plasma concentration versus time curve from time 0 to infinity
Measured: 336 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start3 Sep 2008
- Primary completion28 Nov 2009
- Study completion28 Nov 2009
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 Breast Cancer and Ovarian CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 29 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
- NCT03055143
- Sponsor's protocol ID
- PKD/08/038
- Status last verified
- Jul 2021
- First submitted
- 7 Feb 2017
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.
- ClinicalTrials.gov ID
- NCT03055143
- Acronym / sponsor ID
- PKD/08/038
- Conditions
- Breast Cancer and Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2008 (actual)
- Primary completion
- 28 Nov 2009 (actual)
- Study completion
- 28 Nov 2009 (actual)
- First posted
- 16 Feb 2017 (actual)
- 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.
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC-08-038 | Experimental | Drug: SPARC-08-038, Drug: Ref-08-0382 mg/ml |
| Ref-08-038 | Active comparator | Drug: SPARC-08-038, Drug: Ref-08-038 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
- Subjects who had no evidence of underlying disease
- Subjects who had signed written consent form
Key exclusion criteria (4 listed)
- Females who were pregnant, breastfeeding, or are likely to become pregnant
- Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
- Subjects deemed uncooperative or noncompliant
- Smoking or consumption of any nicotine products
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 |
|---|---|---|
| SPARC-08-0382 mg/ml intravenous infusion | Drug | Ref-08-038, SPARC-08-038 |
| Ref-08-0382 mg/ml intravenous infusion | Drug | Ref-08-038, SPARC-08-038 |
Primary outcome
Maximum measured plasma concentration
Time frame: 336 hours
1 secondary outcome
The area under the plasma concentration versus time curve from time 0 to infinity
Time frame: 336 hours
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 23 Jul 2021.
- 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.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPARC-08-038 and Ref-08-038 in people with Breast Cancer and Ovarian Cancer, run by Sun Pharma Advanced Research Company Limited.
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 4 inclusion and 4 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum measured plasma concentration (time frame: 336 hours). 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 NCT03055143, 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 23 Jul 2021.