Trial Outcomes & Findings for Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C) (NCT NCT06390839)

Last Updated: 2025-11-20

Results Overview

ORR is defined as the percentage of patients whose tumors have a complete or partial response to treatment among analyzable patients. Objective response is defined consistent with Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Details about how to define complete response and partial response can be found in the master protocol. 90% two-sided binomial exact confidence interval is calculated for ORR.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Results posted on

2025-11-20

Participant Flow

Subprotocol Z1C was activated on March 13, 2017. Forty-three patients were enrolled on EAY131-Z1C between March 2017 and June 2021. These patients were enrolled into 2 cohorts, a primary and an expansion cohort. The primary cohort enrolled 35 patients. This subprotocol was suspended in Oct, 2018 after meeting its original accrual goal of 35 patients. This subprotocol was reactivated in May, 2020 and subsequently closed on May 25, 2021, with 8 patients enrolled to the expansion cohort.

Out of the 43 patients, 16 patients were enrolled on the basis of the results from the NCI-MATCH assay and 27 on the basis of the outside assay results. Twelve of the 27 outside lab patients had their samples centrally confirmed.

Participant milestones

Participant milestones
Measure	Treatment (Palbociclib) Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Overall Study STARTED	43
Overall Study Started Protocol Therapy	40
Overall Study Eligible and Treated	38
Overall Study Eligible, Treated and Mutation Status Confirmed	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Palbociclib) Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Overall Study Ineligible	2
Overall Study Never start protocol therapy	3
Overall Study Adverse Event	1
Overall Study Alternative therapy	2
Overall Study Death	3
Overall Study Disease progression	28
Overall Study Withdrawal by Subject	2
Overall Study Complicating disease	1
Overall Study Noncompliance	1

Baseline Characteristics

Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Palbociclib) n=25 Participants Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Age, Continuous	61 years
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	14 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) White	17 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants

PRIMARY outcome

Timeframe: Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=25 Participants Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Objective Response Rate (ORR)	4 percentage of participants Interval 0.2 to 17.6

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined

Population: Eligible, treated and mutation status confirmed

Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=25 Participants Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
6-month Progression Free Survival (PFS) Rate	16.7 percentage of participants Interval 7.9 to 35.3

SECONDARY outcome

Timeframe: Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration

Population: Eligible, treated and mutation status confirmed

PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.

Outcome measures

Outcome measures
Measure	Treatment (Palbociclib) n=25 Participants Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Progression Free Survival	2 months Interval 1.8 to 2.2

Adverse Events

Treatment (Palbociclib)

Serious events: 22 serious events

Other events: 30 other events

Deaths: 33 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Palbociclib) n=40 participants at risk Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Blood and lymphatic system disorders Anemia	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Skin and subcutaneous tissue disorders Rash acneiform	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Infections and infestations Lung infection	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Infections and infestations Sepsis	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Alkaline phosphatase increased	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Lymphocyte count decreased	20.0% 8/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Neutrophil count decreased	35.0% 14/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Platelet count decreased	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations White blood cell decreased	25.0% 10/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Metabolism and nutrition disorders Hyponatremia	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Metabolism and nutrition disorders Hypophosphatemia	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Nervous system disorders Nervous system disorders - Other, specify	2.5% 1/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).

Other adverse events

Other adverse events
Measure	Treatment (Palbociclib) n=40 participants at risk Patients receive palbociclib 125mg PO QD on days 1-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and blood sample collection throughout the trial. Patients may also undergo a biopsy on study.
Blood and lymphatic system disorders Anemia	22.5% 9/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
General disorders Fatigue	42.5% 17/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Bloating	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Constipation	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Diarrhea	10.0% 4/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Nausea	22.5% 9/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Gastrointestinal disorders Vomiting	7.5% 3/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Alanine aminotransferase increased	10.0% 4/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Alkaline phosphatase increased	10.0% 4/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Aspartate aminotransferase increased	10.0% 4/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Blood bilirubin increased	7.5% 3/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Creatinine increased	7.5% 3/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Lymphocyte count decreased	10.0% 4/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Neutrophil count decreased	42.5% 17/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations Platelet count decreased	32.5% 13/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Investigations White blood cell decreased	42.5% 17/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Metabolism and nutrition disorders Anorexia	12.5% 5/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Metabolism and nutrition disorders Hypocalcemia	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Metabolism and nutrition disorders Hypophosphatemia	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Psychiatric disorders Insomnia	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40 • Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration. All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding three who did not receive treatment).

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60