Breast CancerPhase 1NCT01333137
A Clinical Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
A Phase 1 study testing Gemcitabine and Carboplatin and P276-00 along with Gemcitabine and carboplatin in people with Breast Cancer, run by Piramal Enterprises Limited at 4 sites in United States.
Trial summary
P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gemcitabine and Carboplatin and P276-00 along with Gemcitabine and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Mar 2014
- 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
- Females of age ≥18 years.
- Histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for Phase I)
- Two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for Phase I)
- ECOG performance score of 1 or less
- Presence of measurable disease by RECIST 1.1 criteria (not for the Phase I portion)
- Ability to understand and the willingness to sign a written informed consent document (ICD)
- Full recovery from all prior treatment toxicities to Common Terminology Criteria for Adverse Events (CTCAE V.4) Grade ≤ 1
Who cannot join
- Prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
- Prior radiation therapy within 6 weeks of study drug administration
- Subject with known active CNS metastases and/or carcinomatous meningitis. However, subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases (2) off steroids that are used to minimize surrounding brain edema.
- Prior therapy with gemcitabine or a platinum agent (not for the Phase I part)
- Prior therapy with a Cdk/cyclin inhibitor or any flavones derivative
- QTc interval >450 msec (using Fridericia's formula)
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- Any acute illness including uncontrolled diabetes, symptomatic or otherwise uncontrolled cardiac disease (coronary artery disease, arrhythmias, congestive heart failure) or other illness that in the judgment of the investigator would introduce additional medical risks
- Visceral crisis including extensive liver disease with>50% parenchymal involvement or lymphangitic pulmonary disease
- History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, or in situ breast cancer
- Expected survival of less than 3 months
- Hemoglobin <9.0 gm/dL
- Absolute neutrophil count <1500/mm3
- Platelet count <100,000/mm3
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >3 × institutional upper limit of normal (ULN)
- Total bilirubin, >1.5 × institutional ULN
- Serum creatinine >1.5 mg/dL
- Subjects with known infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B
- Pregnant or lactating women
- Women of childbearing potential not willing to use approved methods of contraception after signing the ICD, during the entire study and for at least 4 weeks after completion of study or following withdrawal from the study
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Disney Cancer Center
Burbank, California
3855 Health Sciences Drive
La Jolla, California, 92093
UC Davis Cancer Center
Sacramento, California, 95817
Washington University
St Louis, Missouri
About this study
Official title: An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Gemcitabine and Carboplatin, P276-00 along with Gemcitabine and carboplatin
- Keywords
- Triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine and CarboplatinDrug
Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.
P276-00 along with Gemcitabine and carboplatinDrug
In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and Carboplatin | Active comparator | Gemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days. Receives: Drug: Gemcitabine and Carboplatin |
| P276-00 along with Gemcitabine and carboplatin | Experimental | P276-00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days.In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin. Receives: Drug: P276-00 along with Gemcitabine and carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression free survival
The primary efficacy endpoint will be median progression-free survival (PFS), defined as the time from the beginning of study treatment to the occurrence of documented disease progression or recurrence, or death from any cause
Measured: 1 year and above
Secondary outcomes (5)
Overall survival (OS)
Measured: at 3 years
Overall survival at 6 months
Measured: at 6 months
Progression Free Survival at 6 months
Measured: at 6 months
Objective response rate
Measured: upto 3 years and above
Duration of response
Measured: upto 3 years and above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piramal Enterprises Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.Debasish Tripathy, Principal investigator, USC/Norris Comprehensive Cancer Center 1441 Eastlake Avenue, Rm 3440, Los Angeles, CA 90033
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333137
- Sponsor's protocol ID
- P276-00/52/10
- Status last verified
- Sep 2014
- First submitted
- 8 Apr 2011
- Last updated
- 4 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Randomized Phase II Trial Comparing Gemcitabine and Carboplatin With and Without P276-00 in Subjects With Metastatic Triple Negative Breast Cancer, With a Phase I Run-in of Escalating Dose of P276-00 Added to Gemcitabine and Carboplatin
- ClinicalTrials.gov ID
- NCT01333137
- Acronym / sponsor ID
- P276-00/52/10
- Conditions
- Breast Cancer
- Keywords
- Triple negative breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Piramal Enterprises LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Apr 2011 (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.
P276-00 is a novel, potent, small-molecule, flavone-derived Cdk 4 D1, Cdk1 B, and Cdk9 T inhibitor, with potent cytotoxic effects against chemosensitive and chemoresistant cancer cell lines.This study is planned to compare efficacy of the standard chemotherapy regimen of gemcitabine and carboplatin when administered with or without P276-00 in subjects with advanced triple negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and Carboplatin | Active comparator | Drug: Gemcitabine and CarboplatinGemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days. |
| P276-00 along with Gemcitabine and carboplatin | Experimental | Drug: P276-00 along with Gemcitabine and carboplatinP276-00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days.In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Females of age ≥18 years.
- Histologically documented metastatic triple negative breast cancer (any triple negative breast cancer for Phase I)
- Two or fewer chemotherapy regimens for advanced disease (no limit of prior regimens for Phase I)
- ECOG performance score of 1 or less
- Presence of measurable disease by RECIST 1.1 criteria (not for the Phase I portion)
Key exclusion criteria (20 listed)
- Prior chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration
- Prior radiation therapy within 6 weeks of study drug administration
- Subject with known active CNS metastases and/or carcinomatous meningitis. However, subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases (2) off steroids that are used to minimize surrounding brain edema.
- Prior therapy with gemcitabine or a platinum agent (not for the Phase I part)
- Prior therapy with a Cdk/cyclin inhibitor or any flavones derivative
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 |
|---|---|---|
| Gemcitabine and CarboplatinGemcitabine 1000 mg/m2/day on Days 1 \& 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days. | Drug | Gemcitabine and Carboplatin |
| P276-00 along with Gemcitabine and carboplatinIn phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 \& 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin. | Drug | P276-00 along with Gemcitabine and carboplatin |
Primary outcome
Median Progression free survival
Time frame: 1 year and above
The primary efficacy endpoint will be median progression-free survival (PFS), defined as the time from the beginning of study treatment to the occurrence of documented disease progression or recurrence, or death from any cause
5 secondary outcomes
Overall survival (OS)
Time frame: at 3 years
Overall survival at 6 months
Time frame: at 6 months
Progression Free Survival at 6 months
Time frame: at 6 months
Objective response rate
Time frame: upto 3 years and above
Duration of response
Time frame: upto 3 years and above
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2014.
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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.
Dr.Debasish Tripathy principal investigator
USC/Norris Comprehensive Cancer Center 1441 Eastlake Avenue, Rm 3440, Los Angeles, CA 90033
4 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 Gemcitabine and Carboplatin and P276-00 along with Gemcitabine and carboplatin in people with Breast Cancer, run by Piramal Enterprises Limited at 4 sites in United States.
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 7 inclusion and 20 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: stopped early, as of the sponsor's last update on 4 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 stopped early. Results are not available in the source record.
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?
Median Progression free survival (time frame: 1 year and above). 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 4 Sep 2014.