Metastatic Breast CancerPhase 1NCT04332549
To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer
A Phase 1 study testing PICS (Reconstitution Method 1 or 2) in people with Metastatic Breast Cancer and Locally Recurrent Cancer, run by Sun Pharma Advanced Research Company Limited at 22 sites in India.
Trial summary
A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Locally Recurrent Cancer
- What is being tested?
- PICS (Reconstitution Method 1 or 2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 22 sitesIndia
- Study dates
- 27 Apr 2020to 28 Jan 2021
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer with adequate documentation of prior therapy with an anthracycline unless clinically contraindicated
- Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option
- Male or female aged greater than equal to 18 years
- ECOG performance status less than equal to 1
- Estimated life expectancy of at least 12 weeks
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- Adequate organ and immune system function as indicated by the following laboratory values, obtained less than equal to 2 weeks prior to dosing for Period 1 and Period 2:
- Any chemotherapy, targeted therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrollment (6 weeks for mitomycin C or nitrosurea); immune therapy or hormonal therapy (except palliative bisphosphonate therapy for bone pain) must be completed 2 weeks before enrollment and subjects must have recovered from all toxicities incurred as a result of previous therapy except alopecia; use of targeted therapy or antibody therapy should have been completed for at least 5 half-lives of the respective therapy before enrollment. Use of narcotic analgesics such as dihydrocodeine and medicinal herbs such as St. John's Wort, which may act as inhibitors/inducers of CYP2C8 and CYP3A4, must have been discontinued at least 2 weeks and 4 weeks respectively before enrollment
- Subjects of child bearing potential must practice an acceptable method of birth control as judged by the investigator
- Medically acceptable methods of birth control include the use of either a contraceptive implant or a contraceptive injection (e.g., Depo-Provera™) or an intrauterine device, same sex partner or vasectomized partner or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study
- To adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following:
- diaphragm, cervical cap, condom, or a spermicide at least 2 months prior to study entry and must continue to use contraception for the duration of the study
- Female subjects who are postmenopausal for at least 1 year as per investigator's discretion, or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
- Male subjects enrolled in the trial cannot father a child and are advised to prevent passage of semen to their sexual partner during intercourse using acceptable methods as judged by the investigator for the duration of the study
- Females subjects of child-bearing potential must have a negative urine pregnancy test
- Female subjects must be non-lactating and non-breastfeeding
- Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
Who cannot join
- Known hypersensitivity to the study drug or their excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol, polyethylene glycol)
- Inability to undergo venipuncture and/or tolerate venous access
- Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 5.0)
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study or confound the study
- Presence of pleural/ascitic fluid which cannot be definitively treated prior to dosing and during the PK blood draws in each period (Period 1 and Period 2) and if there is re-accumulation of fluid (greater than 5%) greater than 2 weeks after definitive management
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- Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- Treatment with investigational agents or participation in a clinical trial within 30 days of study entry
- Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit
- Subjects taking concurrent medications that may act as inhibitors/inducers of CYP2C8 and CYP3A4 within 2 weeks of screening and during Periods 1 and 2
- Evidence or history of bleeding diathesis or coagulopathy within 6 months prior to screening visit
- Uncontrolled cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA), history of hypertensive crisis
- Active clinical infection which in the treating investigator's opinion renders the subject ineligible or can confound the study
- Serious non-healing wound, ulcer or bone fracture
- Unresolved toxicity higher than CTCAE Version 5.0 Grade 1 (excluding alopecia, anemia) attributed to any prior therapy/procedure
- History of gastrointestinal perforation within 6 months prior to screening visit.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
India22 sites
SPARC Site 21
Ahmedabad, Gujarat, 380016
SPARC Site 4
Bangalore, Karnataka, 560027
SPARC Site 10
Bangalore, Karnataka, 560054
SPARC Site 18
Bangalore, Karnataka, 560090
SPARC Site 13
Bangalore, Karnataka, 560092
SPARC Site 9
Chhatrapati Sambhajinagar, Maharashtra, 431001
SPARC Site 6
Gujrāt, Vadodara, 391760
SPARC Site 20
Khordha, Odisha, 751007
SPARC Site 8
Kolhāpur, Maharashtra, 416234
SPARC Site 7
Lucknow, Uttar Pradesh, 226003
SPARC Site 14
Madurai, Tamil Nadu, 625107
SPARC Site 2
Nagpur, Maharashtra, 440003
SPARC Site 1
Nagpur, Maharashtra, 440010
SPARC Site 17
Nagpur, Maharashtra, 440024
SPARC Site 3
Nashik, Maharashtra, 422002
SPARC Site 19
Nashik, Maharashtra, 422005
SPARC Site 15
Pune, Maharashtra, 411013
SPARC Site 16
Pune, Maharashtra, 411044
SPARC Site 5
Pune, Maharashtra, 412105
SPARC Site 11
Sangli, Maharashtra, 416410
SPARC Site 22
Surat, Gujarat, 395002
SPARC Site 12
Visakhapatnam, Andhra Pradesh, 530017
About this study
Official title: A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects With Locally Recurrent or Metastatic Breast Cancer.
A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects.
- Conditions
- Metastatic Breast Cancer, Locally Recurrent Cancer
- Being tested
- PICS (Reconstitution Method 1 or 2)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICS (Reconstitution Method 1 or 2)Drug
dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS
| Study group | Role | What they receive |
|---|---|---|
| Reconstitution Method 1 | Active comparator | Not described Receives: Drug: PICS (Reconstitution Method 1 or 2) |
| Reconstitution Method 2 | Active comparator | Not described Receives: Drug: PICS (Reconstitution Method 1 or 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration Plasma
Measured: 8 weeks
area under the plasma concentration versus time curve, from time 0 to the last measurable concentration
Measured: 8 weeks
area under the plasma concentration versus time curve from time 0 to infinity
Measured: 8 weeks
Incidence of Treatment-Emergent Adverse Events
shall be coded per CTCAE, Version 5.0
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start27 Apr 2020 (estimated)
- Primary completion28 Jan 2021 (estimated)
- Study completion28 Jan 2021 (estimated)
Why it stopped: After meeting with the FDA, SPARC concludes a BE study will not be required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT04332549
- Sponsor's protocol ID
- SDO-006-20-01
- Status last verified
- May 2020
- First submitted
- 26 Mar 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects With Locally Recurrent or Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT04332549
- Acronym / sponsor ID
- SDO-006-20-01
- Conditions
- Metastatic Breast Cancer, Locally Recurrent Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After meeting with the FDA, SPARC concludes a BE study will not be required
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2020 (estimated)
- Primary completion
- 28 Jan 2021 (estimated)
- Study completion
- 28 Jan 2021 (estimated)
- First posted
- 2 Apr 2020 (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.
A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reconstitution Method 1 | Active comparator | Drug: PICS (Reconstitution Method 1 or 2) |
| Reconstitution Method 2 | Active comparator | Drug: PICS (Reconstitution Method 1 or 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study
- Histologically or cytologically confirmed diagnosis of breast cancer with adequate documentation of prior therapy with an anthracycline unless clinically contraindicated
- Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option
- Male or female aged greater than equal to 18 years
- ECOG performance status less than equal to 1
Key exclusion criteria (16 listed)
- Known hypersensitivity to the study drug or their excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol, polyethylene glycol)
- Inability to undergo venipuncture and/or tolerate venous access
- Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy
- Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 5.0)
- Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study or confound the study
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 |
|---|---|---|
| PICS (Reconstitution Method 1 or 2)dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS | Drug | Reconstitution Method 1, Reconstitution Method 2 |
Primary outcome
Maximum observed plasma concentration Plasma
Time frame: 8 weeks
area under the plasma concentration versus time curve, from time 0 to the last measurable concentration
Time frame: 8 weeks
area under the plasma concentration versus time curve from time 0 to infinity
Time frame: 8 weeks
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks
shall be coded per CTCAE, Version 5.0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- 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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PICS (Reconstitution Method 1 or 2) in people with Metastatic Breast Cancer and Locally Recurrent Cancer, run by Sun Pharma Advanced Research Company Limited at 22 sites 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 17 inclusion and 16 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: withdrawn, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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 was withdrawn before enrolling participants, so there are no results.
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 observed plasma concentration Plasma (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2020.