Solid NeoplasmPhase 1NCT02897375
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
A Phase 1 study testing Carboplatin, Cisplatin and Palbociclib in people with Solid Neoplasm and Stage III Pancreatic Cancer, run by Emory University at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer
- What is being tested?
- Carboplatin, Cisplatin and Palbociclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2016to 15 Oct 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
- Patients must have histologically or cytologically confirmed solid organ malignancy
- Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
- Leukocytes ≥ 3,000/mL
- Absolute neutrophil count ≥ 1,500/mL
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- Platelets ≥ 100,000/mL
- Hemoglobin ≥ 10 g/dL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (except for patients with Gilbert disease)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (up to 5 X upper limit of normal [ULN] for patients with liver metastasis)
- Creatinine within normal institutional limits OR creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48 hours) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
- Oral targeted therapy within five days or five half-lives, whichever is longer, prior to initiating protocol therapy treatment
- Patients who are receiving any other investigational agents
- Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
- Patients with symptomatic uncontrolled brain metastases are excluded; (patients with stable treated or asymptomatic untreated brain metastasis not requiring glucocorticoids are allowed)
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib, carboplatin or cisplatin
- Concurrent administration of strong inducers and inhibitors of CYP3A enzyme or CYP3A substrates with narrow therapeutic window
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection requiring intravenous antibiotics at the time of treatment initiation
- Symptomatic congestive heart failure (requiring hospital stay within the last 6 months)
- Myocardial infarction within the last 6 months
- Unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness
- Social situations or circumstances that would limit compliance with study requirements
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with palbociclib
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
About this study
Official title: A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies
This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the safety and tolerability of palbociclib when administered along with cisplatin or carboplatin.
II. Establish the recommended phase 2 dose (RP2D) of the tested combinations.
SECONDARY OBJECTIVES:
- Characterize the pharmacokinetic (PK) profiles of cisplatin, carboplatin.
II. Obtain preliminary evidence of anti-tumor efficacy of the tested combination regimens.
III. Conduct PK/pharmacodynamics (PD) correlative analyses using palbociclib trough concentration and cyclin-dependent kinase 4 (CDK4) inhibition read-outs in tumor and surrogate samples collected on course 1 day 22 (C1D22).
IV. Assess potential association between tissue-based biomarkers and efficacy.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms.
ARM A: Patients receive cisplatin intravenously (IV) over 30-60 minutes on day 1 and palbociclib orally (PO) once daily (QD) on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 4 weeks.
- Conditions
- Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-Small Cell Lung Cancer
- Being tested
- Carboplatin, Cisplatin, Palbociclib
- Medical subject headings
- Pancreatic Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Sarcoma, Colorectal Neoplasms, Head and Neck Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin
Given IV
CisplatinDrug
Also called CDDP, Cis-diamminedichloridoplatinum, Cisplatinum, Cismaplat
Given IV
PalbociclibDrug
Also called Ibrance, PD-0332991
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (palbociclib, cisplatin) | Experimental | Patients receive cisplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cisplatin; Drug: Palbociclib |
| Arm B (palbociclib, carboplatin) | Experimental | Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Carboplatin; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Measured: Study completion, an average of 2 years
Incidence of dose limiting toxicities defined as grade 3 or higher toxicity
Measured: Up to 4 weeks
Recommended phase 2 dose (RP2D) as the highest doses of palbociclib and cisplatin or palbociclib and carboplatin
Measured: Study completion, an average of 2 years
Secondary outcomes (3)
Overall response rate (complete response + partial response) assessed by Response Evaluation Criteria in Solid Tumors 1.1 criteria
Will be summarized and presented along with 95% exact confidence intervals.
Measured: Up to 3 years
Pharmacokinetic (PK) characteristics of carboplatin including maximum concentration (Cmax)
Within-subject and between-cohort comparisons of Cmax will be performed using Wilcoxon (non-parametric) test.
Measured: Up to 4 weeks
Pharmacokinetic (PK) characteristics of cisplatin including maximum concentration (Cmax)
Within-subject and between-cohort comparisons of Cmax will be performed using Wilcoxon (non-parametric) test.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start24 Oct 2016
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
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 Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Olatunji Alese, Emory University
- Investigators
- Olatunji B Alese, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897375
- Sponsor's protocol ID
- IRB00089583
- Other IDs
- NCI-2016-01037, Winship3263-16, P30CA138292
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2016
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Alese OB, Harvey RD, Wu C, Hitron E, Collins H, Scott S, Steuer C, Bilen MA, Carthon BC, Switchenko JM, Ramalingam SS, Owonikoko TK. Phase I study of palbociclib with cisplatin or carboplatin in the management of patients with advanced pancreatic cancer. Oncologist. 2025 Oct 1;30(10):oyaf284. doi: 10.1093/oncolo/oyaf284.
PubMed 40973049
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Palbociclib in Combination With Cisplatin or Carboplatin in Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT02897375
- Acronym / sponsor ID
- IRB00089583
- Conditions
- Solid Neoplasm, Stage III Pancreatic Cancer, Stage IIIA Breast Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Breast Cancer, Stage IIIB Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pfizer, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 13 Sep 2016 (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.
This phase I trial studies the side effects and best dose of palbociclib with cisplatin or carboplatin in treating patients with solid tumors that have spread to other places and usually cannot be cured or controlled with treatment. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib with cisplatin or carboplatin may help stop tumor growth in patients with advanced solid tumors.
Detailed description
PRIMARY OBJECTIVES:
- Assess the safety and tolerability of palbociclib when administered along with cisplatin or carboplatin.
II. Establish the recommended phase 2 dose (RP2D) of the tested combinations.
SECONDARY OBJECTIVES:
- Characterize the pharmacokinetic (PK) profiles of cisplatin, carboplatin.
II. Obtain preliminary evidence of anti-tumor efficacy of the tested combination regimens.
III. Conduct PK/pharmacodynamics (PD) correlative analyses using palbociclib trough concentration and cyclin-dependent kinase 4 (CDK4) inhibition read-outs in tumor and surrogate samples collected on course 1 day 22 (C1D22).
IV. Assess potential association between tissue-based biomarkers and efficacy.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 arms.
ARM A: Patients receive cisplatin intravenously (IV) over 30-60 minutes on day 1 and palbociclib orally (PO) once daily (QD) on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (palbociclib, cisplatin) | Experimental | Drug: Cisplatin, Drug: PalbociclibPatients receive cisplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B (palbociclib, carboplatin) | Experimental | Drug: Carboplatin, Drug: PalbociclibPatients receive carboplatin IV over 30-60 minutes on day 1 and palbociclib PO QD on days 2-22. Treatment repeats every 28 days for up to 6 courses in the absence of 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)
- Patients must have histologically or cytologically confirmed solid organ malignancy
- Patients enrolled in the expansion cohort must have histologically or cytologically confirmed squamous non-small cell lung cancer (NSCLC), breast or pancreaticobiliary tract cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) with conventional techniques or as ≥ 10 mm (≥ 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
- Leukocytes ≥ 3,000/mL
Key exclusion criteria (17 listed)
- Patients who have had cytotoxic anticancer chemotherapy or immune checkpoint inhibitor within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or palliative radiation within 2 weeks (stereotactic radiation therapy [SRS] for brain metastasis within 48 hours) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients receiving cytotoxic agent as immunomodulatory therapy for a non neoplastic indication (e.g. methotrexate for rheumatoid arthritis) and who are unable to discontinue such agents within 2 weeks prior to starting treatment
- Oral targeted therapy within five days or five half-lives, whichever is longer, prior to initiating protocol therapy treatment
- Patients who are receiving any other investigational agents
- Use of strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
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 |
|---|---|---|
| CarboplatinAlso: ParaplatinGiven IV | Drug | Arm B (palbociclib, carboplatin) |
| CisplatinAlso: CDDP, Cis-diamminedichloridoplatinum, Cisplatinum, CismaplatGiven IV | Drug | Arm A (palbociclib, cisplatin) |
| PalbociclibAlso: Ibrance, PD-0332991Given PO | Drug | Arm A (palbociclib, cisplatin), Arm B (palbociclib, carboplatin) |
Primary outcome
Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Study completion, an average of 2 years
Incidence of dose limiting toxicities defined as grade 3 or higher toxicity
Time frame: Up to 4 weeks
Recommended phase 2 dose (RP2D) as the highest doses of palbociclib and cisplatin or palbociclib and carboplatin
Time frame: Study completion, an average of 2 years
3 secondary outcomes
Overall response rate (complete response + partial response) assessed by Response Evaluation Criteria in Solid Tumors 1.1 criteria
Time frame: Up to 3 years
Pharmacokinetic (PK) characteristics of carboplatin including maximum concentration (Cmax)
Time frame: Up to 4 weeks
Pharmacokinetic (PK) characteristics of cisplatin including maximum concentration (Cmax)
Time frame: Up to 4 weeks
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 10 Oct 2023.
- Derived from this study: PubMed 40973049Alese OB, Harvey RD, Wu C, Hitron E, Collins H, Scott S, Steuer C, Bilen MA, Carthon BC, Switchenko JM, Ramalingam SS, Owonikoko TK. Phase I study of palbociclib with cisplatin or carboplatin in the management of patients with advanced pancreatic cancer. Oncologist. 2025 Oct 1;30(10):oyaf284. doi: 10.1093/oncolo/oyaf284.
- Individual participant dataSharing planned: Undecided
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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.
Olatunji B Alese, MD principal investigator
Emory University
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 Carboplatin, Cisplatin and Palbociclib in people with Solid Neoplasm and Stage III Pancreatic Cancer, run by Emory University 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 17 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 10 Oct 2023. 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 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?
Incidence of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (time frame: Study completion, an average of 2 years). The study lists 3 primary outcomes in all. 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 NCT02897375, 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 10 Oct 2023.