TerminatedNCT01227434PD0332991Updated Jul 17, 2015Results posted

A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma

A Phase 2 interventional study of PD 0332991 (pre-surgery) and PD 0332991 in Glioblastoma, Gliosarcoma and Anaplastic Astrocytoma, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-17.

Sponsored by University of California, San Francisco · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 23
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This study will determine the efficacy of the small molecule CDK4/6 inhibitor PD 0332991 (as measured by progression free survival at 6 months) in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive. A total of 30 patients will be treated; 15 will undergo a planned surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery, and the other 15 patients will receive drug without a planned surgical procedure.

Read the detailed description

A total of 30 patients with recurrent Glioblastoma or Gliosarcoma will be treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Of these 30 patients, 15 will receive drug for 7 days prior to an indicated, intended surgical resection for progression, and will then resume drug at the same dose after recovery from surgery. Treatment will be repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients will be given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.

Following registration, available blocks or slides from a previous surgery must be submitted for diagnosis review (confirmation of Glioblastoma multiforme or Gliosarcoma) and Rb status determination. Only patients with Rb positive tumors can be treated, and Rb tumor status must be known prior to any treatment. Additional tissue from previous surgeries will also be obtained to evaluate molecular abnormalities in the tumor. These studies will be done retrospectively and are not required to be performed prior to registration.

Monitoring will include a clinical and neurological exam before the beginning of each cycle (every 4 weeks). Complete blood counts with differential will be examined on days 1 and 15 of each cycle. Liver and renal function will be performed every 4 weeks. Toxicity and dose modifications will be based on the NCI CTCAE Version 4. Disease status will be assessed clinically each cycle (every 4 weeks) and radiographically after each second cycle (every 8 weeks).

Conditions studied

Glioblastoma
Gliosarcoma
Anaplastic Astrocytoma

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Keywords

Glioblastoma
Gliosarcoma
Anaplastic astrocytoma
Malignant astrocytoma NOS
Malignant glioma
GBM

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.

This study's enrollment of 23 is below the median of 36 across 1,617 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients 18 years or older with KPS > 60, with life expectancy of > 8 weeks with radiographically proven recurrent, intracranial Glioblastoma multiforme or Gliosarcoma; patients must have documentation of Rb positive disease.
All patients must sign an informed consent and must have signed an authorization for the release of their protected health information.
Patients must have had prior external beam radiation and temozolomide chemotherapy; there is no limit to the number of prior chemotherapies used; patients may be treated in their first, second or third relapse
Patients must have recovered from the toxic effects of prior therapy
Patients must have adequate bone marrow function and renal function before starting therapy. A pre-study EKG with a normal QT interval is required for all patients
Patients must have shown unequivocal evidence for tumor progression by MRI scan and on a steroid dose that has been stable for at least 7 days.
Patients must have an interval of greater than or equal to 42 days from the completion of radiation therapy to study entry.
A subset of 15 patients will be enrolled prior to a planned, indicated surgical resection. Patients can be enrolled pre-operatively only if they are surgical candidates, do not have evidence of an acute intracranial hemorrhage and are able to start protocol treatment in a window of 7 days before surgery.
Male and female patients with reproductive potential must use an approved contraceptive method. Women of childbearing potential must have a negative beta-HCG pregnancy test
Blocks or slides of tumor tissue from a previous surgery must be available to do IHC Rb staining. Patients with negative tumors (Rb negative) will be excluded from the study.

Exclusion criteria

Exclusion Criteria:

Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.
Patients on enzyme-inducing anti-epileptic drugs or other drugs that cause CYP3A enzyme induction or inhibition will not be eligible

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 23 participants (actual)

Study arms

Experimental
Surgical Group
PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection as clinical care for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment will be repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients will be given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
Drug: PD 0332991 (pre-surgery) · Drug: PD 0332991 · Procedure: Resection as clinical care
Experimental
Non-surgical group
Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment will be repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients will be given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
Drug: PD 0332991

Interventions

DrugPD 0332991 (pre-surgery)
PD 0332991 for 7 days prior to an indicated, intended surgical resection for progression
Also known as: Pfizer PD 0332991, palbociclib, IBRANCE, Pfizer, Inc.
DrugPD 0332991
PD 0332991 daily for 21 consecutive days followed by a 7 day break off therapy, repeating cycles
Also known as: Pfizer PD 0332991, palbociclib, IBRANCE, Pfizer, Inc.
ProcedureResection as clinical care
Indicated, intended, surgical resection as clinical care

What researchers measure

Primary outcomes

Progression Free Survival
Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.
Time frame: up to 142 weeks

Secondary outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
The number of participants with protocol related toxicity described by CTCAE version 4.0
Time frame: 1-2 years

Results

Posted Jun 12, 2015

Participant flow

Participant flow — Overall Study
Milestone	Surgical Group	Non-surgical Group
Started	6	16
Completed	6	16
Not completed	0	0

Outcome measures

PrimaryProgression Free Survival

Efficacy of the small molecule CDK4/6 inhibitor PD 0332991 in patients with recurrent glioblastoma multiforme or gliosarcoma who are Rb positive was measured by progression free survival. A total of 30 patients was intended to be treated; up to 15 patients were to undergo a planned, intended surgical resection and receive drug for 7 days prior to surgery, followed by drug after recovery from surgery; and up to 15 patients were to receive drug without a planned surgical procedure.

Time frame:: up to 142 weeks
Reported as:: Mean · weeks

Progression Free Survival
weeks	Surgical Group	Non-surgical Group
Progression Free Survival	4 (3 to 6)	14 (1 to 142)

Statistical analysis

Surgical Group vs Non-surgical Group · Exact binomial distribution · p = 0.10 · Exact binomial distribution: 0.10

SecondaryNumber of Participants With Adverse Events as a Measure of Safety and Tolerability

The number of participants with protocol related toxicity described by CTCAE version 4.0

Time frame:: 1-2 years
Reported as:: Number · participants

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
participants	Surgical Group	Non-surgical Group
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	6	16

Adverse events

Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Surgical Group	—	5/6 (83.3%)	4/6 (66.7%)
Non-surgical Group	—	4/16 (25%)	15/16 (93.8%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	Surgical Group	Non-surgical Group
HeadacheNervous system disorders	2/6	1/16
SeizureNervous system disorders	2/6	0/16
Death NOSGeneral disorders	1/6	2/16
MeningitisInfections and infestations	1/6	0/16
Wound InfectionInfections and infestations	1/6	0/16
Muscle WeaknessMusculoskeletal and connective tissue disorders	1/6	0/16
Cerebral Spinal Fluid LeakageNervous system disorders	1/6	0/16
Cognitive disturbanceNervous system disorders	1/6	0/16
Peripheral Motor NeuropathyNervous system disorders	0/6	1/16
Abdominal PainGastrointestinal disorders	0/6	1/16

Most frequent other events

Showing 10 of 101

Most frequent other events
Event	Surgical Group	Non-surgical Group
Neutrophil count decreasedInvestigations	0/6	8/16
HeadacheNervous system disorders	2/6	8/16
FatigueGeneral disorders	2/6	7/16
Lymphocyte count decreasedInvestigations	2/6	7/16
Alanine aminotransferase increasedInvestigations	2/6	0/16
Cognitive disturbanceNervous system disorders	2/6	1/16
SeizureNervous system disorders	2/6	0/16
Platelet count decreasedInvestigations	1/6	5/16
White blood cell decreasedInvestigations	0/6	5/16
Mucositis OralGastrointestinal disorders	0/6	4/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Surgical Group	Non-surgical Group	Total
<=18 years	0	0	0
Between 18 and 65 years	5	14	19
>=65 years	1	2	3

Sex: Female, Male
Sex: Female, Male(Participants)	Surgical Group	Non-surgical Group	Total
Female	3	7	10
Male	3	9	12

Region of Enrollment
Region of Enrollment(participants)	Surgical Group	Non-surgical Group	Total
United States	6	16	22

Study locations

1 site

University of California, San Francisco
San Francisco, California 94143, United States

References and documents

Publications

Taylor JW, Parikh M, Phillips JJ, James CD, Molinaro AM, Butowski NA, Clarke JL, Oberheim-Bush NA, Chang SM, Berger MS, Prados M. Phase-2 trial of palbociclib in adult patients with recurrent RB1-positive glioblastoma. J Neurooncol. 2018 Nov;140(2):477-483. doi: 10.1007/s11060-018-2977-3. Epub 2018 Aug 27. PubMed 30151703 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01227434
Lead sponsor: University of California, San Francisco
Collaborators: Pfizer
Responsible party: Sponsor
First posted: Oct 25, 2010
Start date: Sep 2010
Primary completion: Dec 2013
Completion: Dec 2013
Results posted: Jun 12, 2015
Last update: Jul 17, 2015

Study contacts

Michael D Prados, MD

principal investigator · University of California, San Francisco

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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