A Phase 2 interventional study of PD-0332991 in Adult Solid Tumor, Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, sponsored by Abramson Cancer Center at Penn Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Abramson Cancer Center at Penn Medicine · Phase 2, Interventional, and Treatment
RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.
PRIMARY OBJECTIVES:
I. To determine the response rates following treatment with PD 0332991 in the following malignancies: 1) Metastatic breast cancer, 2) Metastatic colorectal cancer, 3) Metastatic melanoma with CDK4 mutation or amplification, or 4) Cisplatin-refractory, unresectable germ cell tumors.
OUTLINE:
Patients receive oral PD 0332991 once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's enrollment of 304 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Abramson Cancer Center at Penn Medicine is the lead sponsor of 460 studies on the registry; 87 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 14 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Subjects: All subjects treated under this protocol will have documented cancer of one of the following types:
A. breast cancer (7 triple negative, 23 ER+ after the first 15 patients are enrolled on the non-CCND1cohort; in addition 10 + for combination trastuzumab and PD0332991 therapy) up to 55 total enrollment slots B. Metastatic colorectal cancer that harbors the Kras or BRAF mutation (15-30 enrollment slots) C. Advanced or metastatic esophageal and/or gastric cancer (15-30 enrollment slots) D. Cisplatin-, unresectable germ cell tumors (15-30 enrollment slots) E. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint. (15-30 enrollment slots)
A. ER positive metastatic breast tumors (data now shows all to be Rb positive.) B. Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation, CCND2 amplification OR any other functional alteration at the G1/S checkpoint.
Exclusion Criteria
The subject has uncontrolled intercurrent illness including, but not limited to:
baseline HIV screening is not required
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastatic breast cancer PD-0332991 Given orally, 125 mg QD on a 21-day
Drug: PD-0332991
Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991 Given orally, 125 mg QD on a 21-day
Drug: PD-0332991
Advanced or metastatic esophageal and/or gastric cancer PD-0332991 Given orally, 125 mg QD on a 21-day
Drug: PD-0332991
Cisplatin-refractory, unresectable germ cell tumors PD-0332991 Given orally, 125 mg QD on a 21-day
Drug: PD-0332991
Any tumor type if tissue tests positive for CCND1 amplification, CDK4/6 mutation , CCND2 amplification OR any other functional alteration at the G1/S checkpoint. PD-0332991 Given orally, 125 mg QD on a 21-day
Drug: PD-0332991
Given orally, 125 mg QD on a 21-day
Also known as: Palbociclib
Response Rates
Response rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)
Time frame: 10 years
| Milestone | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
|---|---|---|---|---|---|
| Started | 63 | 18 | 19 | 30 | 11 |
| Completed | 63 | 18 | 19 | 30 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Response rates will be measured using the Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) - Disappearance of all target lesions Partial Response (PR) - ≥30% decrease in the sum of the longest diameter of the target lesions compared with baseline Progressive Disease (PD) - ≥20% increase in the sum of the longest diameter of the target lesions compared with the smallest sum of the longest diameter recorded since treatment started OR The appearance of 1 or more new lesions Stable Disease (SD) - Neither PR or PD Not Evaluable (NE)
| Participants | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
|---|---|---|---|---|---|
| partial response | 4 | 0 | 0 | 0 | 0 |
| stable disease | 32 | 6 | 6 | 17 | 3 |
| progressive disease | 25 | 8 | 4 | 9 | 7 |
| not evaluable for response | 2 | 4 | 9 | 4 | 1 |
Collected over 10years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 0/63 (0%) | 1/63 (1.6%) | 40/63 (63.5%) |
| Arm 2 | 0/18 (0%) | 10/18 (55.6%) | 18/18 (100%) |
| Arm 3 | 1/19 (5.3%) | 11/19 (57.9%) | 19/19 (100%) |
| Arm 4 | 0/30 (0%) | 10/30 (33.3%) | 25/30 (83.3%) |
| Arm 5 | 1/11 (9.1%) | 4/11 (36.4%) | 11/11 (100%) |
| Event | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
|---|---|---|---|---|---|
| leukopeniaInvestigations | 0/63 | 5/18 | 4/19 | 10/30 | 0/11 |
| neutropeniaInvestigations | 0/63 | 6/18 | 6/19 | 10/30 | 2/11 |
| lymphopeniaInvestigations | 0/63 | 0/18 | 6/19 | 0/30 | 1/11 |
| anemiaBlood and lymphatic system disorders | 1/63 | 0/18 | 5/19 | 0/30 | 0/11 |
| thrombocytopeniaInvestigations | 0/63 | 1/18 | 2/19 | 5/30 | 2/11 |
| elevated alk phosInvestigations | 0/63 | 2/18 | 3/19 | 0/30 | 1/11 |
| elavated ALTInvestigations | 0/63 | 2/18 | 1/19 | 0/30 | 0/11 |
| elevated ASTInvestigations | 0/63 | 2/18 | 1/19 | 0/30 | 0/11 |
| thromboembolic eventBlood and lymphatic system disorders | 0/63 | 2/18 | 0/19 | 0/30 | 0/11 |
| diarrheaGastrointestinal disorders | 0/63 | 1/18 | 0/19 | 0/30 | 0/11 |
| Event | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 |
|---|---|---|---|---|---|
| anemiaBlood and lymphatic system disorders | 34/63 | 10/18 | 7/19 | 7/30 | 5/11 |
| thrombocytopeniaInvestigations | 26/63 | 10/18 | 9/19 | 9/30 | 6/11 |
| fatigueGeneral disorders | 28/63 | 8/18 | 9/19 | 9/30 | 2/11 |
| leukopeniaInvestigations | 17/63 | 0/18 | 9/19 | 11/30 | 2/11 |
| nauseaNervous system disorders | 9/63 | 7/18 | 4/19 | 4/30 | 2/11 |
| neutropeniaInvestigations | 18/63 | 6/18 | 7/19 | 9/30 | 1/11 |
| weight lossInvestigations | 1/63 | 5/18 | 0/19 | 2/30 | 0/11 |
| anorexiaMetabolism and nutrition disorders | 7/63 | 4/18 | 5/19 | 3/30 | 0/11 |
| diarrheaGastrointestinal disorders | 13/63 | 2/18 | 4/19 | 3/30 | 1/11 |
| vomitingGastrointestinal disorders | 0/63 | 3/18 | 4/19 | 3/30 | 2/11 |
| Age, Categorical(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 1 | 0 | 1 |
| Between 18 and 65 years | 48 | 10 | 11 | 29 | 11 | 109 |
| >=65 years | 15 | 8 | 8 | 0 | 0 | 31 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | Total |
|---|---|---|---|---|---|---|
| Female | 63 | 8 | 4 | 4 | 9 | 88 |
| Male | 0 | 10 | 15 | 26 | 2 | 53 |
| Race/Ethnicity, Customized(Participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | Total |
|---|---|---|---|---|---|---|
| Asian | 0 | 0 | 0 | 0 | 0 | 0 |
| Black | 3 | 1 | 1 | 3 | 0 | 8 |
| Other | 2 | 1 | 0 | 4 | 0 | 7 |
| White | 58 | 16 | 18 | 23 | 11 | 126 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Arm 3 | Arm 4 | Arm 5 | Total |
|---|---|---|---|---|---|---|
| United States | 63 | 18 | 19 | 30 | 11 | 141 |
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Palbociclib
Abramson Cancer Center at Penn Medicine →