Cancer, AdvancedPhase 2NCT03123744
Histology-Independent Study of Palbociclib in Patients With Advanced Cancer
A Phase 2 study testing Palbociclib 125mg in people with Cancer, Advanced, run by Razelle Kurzrock, MD at 1 site in United States.
Trial summary
The investigational drug being tested in this study is palbociclib. Palbociclib is considered experimental because it is not approved by the FDA for the treatment of all cancers. Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging to a family of drugs called kinase inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced
- What is being tested?
- Palbociclib 125mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Feb 2024
- Phase
- Phase 2
- 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
- Age ≥ 18 years old
- Pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Subject is intolerant to standard therapy
- Subject refuses standard therapy
- Malignancy is refractory to standard therapy
- Malignancy relapsed after standard therapy
Show all 13Show fewer
- Malignancy for which there is no standard therapy that improves survival by at least 3 months.
- Evaluable tumor(s) with documented alteration(s) in CCN/CDK-related gene(s). The CCN/CDK aberration(s) can be identified at any point in the subject's cancer course. CCN/CDK testing must have been performed in a CLIA-certified laboratory. Amplification(s) and/or mutation frequencies will be defined according to the standard of the test used.
- ECOG Performance Status 0-2
- Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study and for at least 30 days after discontinuation of study drug (the half life of palbociclib is about 27 hours in patients with cancer).
- Subjects must be off other anti-tumor agents for at least 5 half lives of the agent or 4 weeks from the last day of treatment, whichever is shorter. Endocrine therapies (for example for breast or prostate cancer) and anti-Her2 therapies (for example, trastuzumab or lapatinib) are allowed to continue while on this study.
- Subjects may not be receiving any other experimental agents.
- Ability to understand and willingness to sign a written consent document.
Who cannot join
- Pregnant or lactating women.
- Subjects who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0(1) (CTCAE v4.0) or to their clinical baseline.
- Inability to swallow pills or determination by the investigator that absorption of oral medication would be impaired.
- Major surgery (not including placement of central lines) within 3 weeks prior to trial enrollment or planned surgery during the course of this study.
- Any medical condition which, in the opinion of the investigator, would preclude study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: A Histology-Independent Study of the Cyclin Inhibitor Palbociclib in Patients With Advanced Cancer Harboring Aberrations in the Cyclin Pathway
The investigational drug being tested in this study is palbociclib. Palbociclib is considered experimental because it is not approved by the FDA for the treatment of all cancers. Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging to a family of drugs called kinase inhibitors. These drugs slow or stop the activity of particular proteins involved in the growth of human cells and in the abnormal growth of cancer cells. Blocking these proteins may decrease or stop tumor growth. The purpose of this study is to assess the safety of the study drug, to see how well it is tolerated, and also to find a safe dose range of the study drug in patients with specific kinds of tumor genetic changes.
Read the detailed description
This study proposes to give the cyclin dependent kinase (CDK) inhibitor palbociclib to patients with advanced malignancy harboring cyclin pathway aberrations (CCN/CDK alterations). The investigators study will determine whether cyclin signaling aberrations associate with response to this CDK inhibitor. Once completed, this study will identify subpopulations of patients that would best benefit from CDK inhibitor therapy with palbociclib and suggest directions for future study.
- Conditions
- Cancer, Advanced
- Being tested
- Palbociclib 125mg
- Keywords
- Palbociclib, Cyclin Pathway, kinase inhibitor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palbociclib 125mgDrug
Also called Ibrance®
Palbociclib 125 mg is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study evaluations include physical exams, performance status, vital signs, laboratory blood tests, and radiographic or MRI imaging.
| Study group | Role | What they receive |
|---|---|---|
| Palbociclib 125 mg | Experimental | Palbociclib is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study measurements will be obtained at baseline and about every 8 weeks thereafter. Subjects will continue study drug until disease progression or unacceptable toxicity. Receives: Drug: Palbociclib 125mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates in subjects with advanced cancer and aberrations of cyclin pathway gene(s) who are treated with palbociclib
Radiographic or MRI imaging will be assessed approximately every 8 weeks for disease progression.
Measured: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Complete physical exams will be assessed every 2 to 4 weeks during treatment to evaluate the number of patients with a drug toxicity and disease progression.
Measured: Every 2-4 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Laboratory blood tests will be assessed every 2 to 4 weeks during treatment to evaluate the number of patients for drug toxicity and disease progression.
Measured: Every 2-4 weeks from date of enrollment, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jul 2018 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2024 (estimated)
Why it stopped: No study funding available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, AdvancedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, open-label, non-randomized Phase II study of palbociclib in adult subjects with recurrent or refractory advanced cancers with aberration(s) in cyclin (CCN/CDK) signaling. Treatment will consist of daily oral administration of palbociclib in 28-day cycles.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Razelle Kurzrock, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Razelle Kurzrock, MD, University of California, San Diego
- Investigators
- Scott Lippman, MD, Study director, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123744
- Sponsor's protocol ID
- UCSD IIT 150729
- Status last verified
- Jun 2018
- First submitted
- 3 Mar 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histology-Independent Study of the Cyclin Inhibitor Palbociclib in Patients With Advanced Cancer Harboring Aberrations in the Cyclin Pathway
- ClinicalTrials.gov ID
- NCT03123744
- Acronym / sponsor ID
- UCSD IIT 150729
- Conditions
- Cancer, Advanced
- Keywords
- Palbociclib, Cyclin Pathway, kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No study funding available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Razelle Kurzrock, MDUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 21 Apr 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.
The investigational drug being tested in this study is palbociclib. Palbociclib is considered experimental because it is not approved by the FDA for the treatment of all cancers. Palbociclib is currently approved for use in breast cancer. Palbociclib is a drug belonging to a family of drugs called kinase inhibitors. These drugs slow or stop the activity of particular proteins involved in the growth of human cells and in the abnormal growth of cancer cells. Blocking these proteins may decrease or stop tumor growth. The purpose of this study is to assess the safety of the study drug, to see how well it is tolerated, and also to find a safe dose range of the study drug in patients with specific kinds of tumor genetic changes.
Detailed description
This study proposes to give the cyclin dependent kinase (CDK) inhibitor palbociclib to patients with advanced malignancy harboring cyclin pathway aberrations (CCN/CDK alterations). The investigators study will determine whether cyclin signaling aberrations associate with response to this CDK inhibitor. Once completed, this study will identify subpopulations of patients that would best benefit from CDK inhibitor therapy with palbociclib and suggest directions for future study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, open-label, non-randomized Phase II study of palbociclib in adult subjects with recurrent or refractory advanced cancers with aberration(s) in cyclin (CCN/CDK) signaling. Treatment will consist of daily oral administration of palbociclib in 28-day cycles.
| Arm | Type | Receives |
|---|---|---|
| Palbociclib 125 mg | Experimental | Drug: Palbociclib 125mgPalbociclib is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study measurements will be obtained at baseline and about every 8 weeks thereafter. Subjects will continue study drug until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years old
- Pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Evaluable tumor(s) with documented alteration(s) in CCN/CDK-related gene(s). The CCN/CDK aberration(s) can be identified at any point in the subject's cancer course. CCN/CDK testing must have been performed in a CLIA-certified laboratory. Amplification(s) and/or mutation frequencies will be defined according to the standard of the test used.
- ECOG Performance Status 0-2
- Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study and for at least 30 days after discontinuation of study drug (the half life of palbociclib is about 27 hours in patients with cancer).
Key exclusion criteria (5 listed)
- Pregnant or lactating women.
- Subjects who have not recovered from toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0(1) (CTCAE v4.0) or to their clinical baseline.
- Inability to swallow pills or determination by the investigator that absorption of oral medication would be impaired.
- Major surgery (not including placement of central lines) within 3 weeks prior to trial enrollment or planned surgery during the course of this study.
- Any medical condition which, in the opinion of the investigator, would preclude study participation
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 |
|---|---|---|
| Palbociclib 125mgAlso: Ibrance®Palbociclib 125 mg is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study evaluations include physical exams, performance status, vital signs, laboratory blood tests, and radiographic or MRI imaging. | Drug | Palbociclib 125 mg |
Primary outcome
Response rates in subjects with advanced cancer and aberrations of cyclin pathway gene(s) who are treated with palbociclib
Time frame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Radiographic or MRI imaging will be assessed approximately every 8 weeks for disease progression.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Every 2-4 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Every 2-4 weeks from date of enrollment, assessed up to 36 months.
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 21 Jun 2018.
- 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.
Scott Lippman, MD study director
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib 125mg in people with Cancer, Advanced, run by Razelle Kurzrock, MD at 1 site 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 13 inclusion and 5 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 21 Jun 2018. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response rates in subjects with advanced cancer and aberrations of cyclin pathway gene(s) who are treated with palbociclib (time frame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.). 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 21 Jun 2018.