AzTrials
AzTrials

Ovarian Epithelial CarcinomaPhase 2NCT01536743

A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

A Phase 2 study testing PD0332991 in people with Ovarian Epithelial Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Epithelial Carcinoma
What is being tested?
PD0332991
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
15 Dec 2011to 24 Feb 2020
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
  • 2. Baseline paraffin embedded tissue from the patient's primary diagnosis is requested before study enrolment and should be forwarded to the designated central laboratory where central assessment of Rb and p16 expression will be performed by using immunohistochemistry. In patients with measurable disease a tissue biopsy may be obtained by core biopsy and submitted to the designated central laboratory.
  • GCIG-defined CA125 progression and absence of disease upon imaging or small-volume asymptomatic disease upon imaging and who have progressed following one, two or three lines of chemotherapy for recurrent disease.
  • If patients have small-volume disease the current study will be restricted to patients with minimal ascites not causing abdominal distention/mesenteric thickening or not requiring paracentesis, or lesions ≤4 cm by spiral computed tomography [CT] or magnetic resonance imaging [MRI] at baseline.
  • Two pretreatment CA125 values (documented on two occasions taken at least one week apart) must be at least twice the upper limit of normal, or twice the nadir value if pretreatment CA125 values never normalized.
  • Patients with platinum-sensitive or platinum-resistant disease defined by recurrence or progression of disease > 6 months or ≤ than 6 months after completion of frontline platinum based chemotherapy.
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  • ECOG performance status ≤ 1 and patients are to be ≥21 years of age.
  • Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 Grade ≤ 1 and to baseline laboratory values as defined in the inclusion criterion immediately below.
  • Adequate organ and bone marrow function as evidenced by:
  • hemoglobin ≥ 9.0 g/dL
  • absolute neutrophil count ≥ 1.5 x 109/L
  • platelet count ≥ 100 x 109/L
  • Renal function, as follows:
  • Serum creatinine ≤ 1.5 x the ULN or calculated creatinine clearance ≥ 40 mL/min
  • AST and ALT ≤ 2.5 x ULN
  • total bilirubin ≤ 1.5 x ULN unless increase is due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin,
  • Adequate coagulation parameters (within 21 days prior to registration), International Normalized Ratio (INR) ≤1.5; Activated ProThrombin Time (APTT) ≤ 1.5 x ULN.
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study.

Who cannot join

  • Patients presenting with any of the following will not be included in the study:
  • More than 4 prior chemotherapy regimens in the treatment of ovarian cancer.
  • Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial.
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast.
  • Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrolment.
  • Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event. PD0332991 in Recurrent Ovarian Cancer
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  • History of brain metastases, spinal cord compression, or carcinomatous meningitis.
  • Patient of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months.
  • Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal IUD, condoms, sexual abstinence or vasectomised partner.
  • Known active infection, or on antiretroviral therapy for HIV disease or positive test for chronic hepatitis B or C infection.
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial.
  • Refusal or inability to give informed consent to participate in the trial.
  • Corrected QT (QTc) interval >470 msec.
  • If radiotherapy is required in a given patient, that patient should be withdrawn from the study.
  • Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delavirdine.
  • Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: A Open Label Phase II Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression

The purpose of this study is to obtain an estimate of the biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

Being tested
PD0332991
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD0332991Drug

    30 patients with recurrent ovarian epithelial carcinoma demonstrating Rb-proficiency and absent or low expression of p16 will be registered to receive PD0332991 once a day by mouth in the morning on an empty stomach.

    PD0332991 will be administered daily for 3 weeks followed by 1 week off treatment (28 day cycle).

Study groups in NCT01536743
Study groupRoleWhat they receive
PD0332991Experimental30 patients with recurrent ovarian epithelial carcinoma demonstrating Rb-proficiency and absent or low expression of p16 will be registered to receive PD0332991 once a day by mouth in the morning on an empty stomach. PD0332991 will be administered daily for 3 weeks followed by 1 week off treatment (28 day cycle).
Receives: Drug: PD0332991

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma.

    CA125 response is defined as ≥ 50% decrease from the baseline CA125 level and confirmed ≥ 21 days after initial evaluation (baseline is defined as the higher value of 2 pre-treatment CA125 assessments).

    Measured: 4 weeks

Secondary outcomes (2)

  1. Toxicity of PD0332991.

    Toxicity of PD0332991 will be graded using the NCI Common Toxicity Criteria, version 3.0

    Measured: 4 weeks

  2. Assess health-related quality of life (HRQL),

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2012 (estimated)
  2. Study start15 Dec 2011
  3. Primary completion24 Feb 2020
  4. Study completion24 Feb 2020

Resources

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
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536743
Sponsor's protocol ID
11-003234
Status last verified
Jun 2020
First submitted
1 Dec 2011
Last updated
5 Jun 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Konecny GE, Davidson TM, Lebreton CL, Marsh LA, Chetram DK, Atkinson HJ, Larson MC, Oberg AL, Abdelaal N, Silverstein J, Jatoi A, Washburn A, Burton J, Dowdy S, Zhang L, Hallberg D, Velculescu VE, Slamon DJ, Wahner-Hendrickson AE. Phase II study of the efficacy and safety of palbociclib in patients with recurrent ovarian cancer. Int J Gynecol Cancer. 2025 Oct;35(10):102028. doi: 10.1016/j.ijgc.2025.102028. Epub 2025 Jul 28.

    PubMed 40839974

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD0332991 in people with Ovarian Epithelial Carcinoma, run by Jonsson Comprehensive Cancer Center 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 19 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: finished, as of the sponsor's last update on 5 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 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 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?

Estimate biochemical response rate as determined by CA125 response using the Gynecologic Cancer Intergroup (GCIG) response criteria of PD0332991 in patients with recurrent ovarian epithelial carcinoma. (time frame: 4 weeks). 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 NCT01536743, 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 5 Jun 2020.

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