Trial · NCT01037790

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

NCT01037790, Phase 2, Completed, Abramson Cancer Center at Penn Medicine; results first posted 2021-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer. Trials, record NCT01037790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01037790

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
NCT number: NCT01037790
Status: Completed
Phases: Phase 2
Enrollment: 304 participants, actual
Lead sponsor: Abramson Cancer Center at Penn Medicine
Conditions: Adult Solid Tumor, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Adult Central Nervous System Germ Cell Tumor, Adult Teratoma, Benign Teratoma, Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, Familial Testicular Germ Cell Tumor, HER2-negative Breast Cancer, HER2-positive Breast Cancer, Male Breast Cancer, Ovarian Immature Teratoma, Ovarian Mature Teratoma, Ovarian Monodermal and Highly Specialized Teratoma, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Recurrent Colon Cancer, Recurrent Extragonadal Germ Cell Tumor, Recurrent Extragonadal Non-seminomatous Germ Cell Tumor, Recurrent Extragonadal Seminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Melanoma, Recurrent Ovarian Germ Cell Tumor, Recurrent Rectal Cancer, Stage III Extragonadal Non-seminomatous Germ Cell Tumor, Stage III Extragonadal Seminoma, Stage III Malignant Testicular Germ Cell Tumor, Stage III Ovarian Germ Cell Tumor, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Extragonadal Non-seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Melanoma, Stage IV Ovarian Germ Cell Tumor, Stage IV Rectal Cancer, Testicular Immature Teratoma, Testicular Mature Teratoma
Interventions: PD-0332991
First posted: 2009-12-23
Last updated: 2021-03-11
Results first posted: 2021-03-11

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Response Rates	10 years	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)

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rates	10 years		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Response Rates	Arm 1	partial response	4	Participants
Response Rates	Arm 2	partial response	0	Participants
Response Rates	Arm 3	partial response	0	Participants
Response Rates	Arm 4	partial response	0	Participants
Response Rates	Arm 5	partial response	0	Participants
Response Rates	Arm 1	stable disease	32	Participants
Response Rates	Arm 2	stable disease	6	Participants
Response Rates	Arm 3	stable disease	6	Participants
Response Rates	Arm 4	stable disease	17	Participants
Response Rates	Arm 5	stable disease	3	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm 1	63
Overall Study	STARTED	Arm 2	18
Overall Study	STARTED	Arm 3	19
Overall Study	STARTED	Arm 4	30
Overall Study	STARTED	Arm 5	11
Overall Study	COMPLETED	Arm 1	63
Overall Study	COMPLETED	Arm 2	18
Overall Study	COMPLETED	Arm 3	19
Overall Study	COMPLETED	Arm 4	30
Overall Study	COMPLETED	Arm 5	11

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events465

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	aches	General disorders	Arm 1	9	63	9
other	aches	General disorders	Arm 2	0	18	0
other	aches	General disorders	Arm 3	0	19	0
other	aches	General disorders	Arm 4	0	30	0
other	aches	General disorders	Arm 5	0	11	0
other	acne	Skin and subcutaneous tissue disorders	Arm 1	1	63	1
other	acne	Skin and subcutaneous tissue disorders	Arm 2	0	18	0
other	acne	Skin and subcutaneous tissue disorders	Arm 3	0	19	0
other	acne	Skin and subcutaneous tissue disorders	Arm 4	0	30	0
other	acne	Skin and subcutaneous tissue disorders	Arm 5	0	11	0

1 to 10 of 465Source ClinicalTrials.gov

See all 465 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm 1	0	63
Total, all-cause mortality	Arm 2	0	18
Total, all-cause mortality	Arm 3	1	19
Total, all-cause mortality	Arm 4	0	30
Total, all-cause mortality	Arm 5	1	11
Total, other adverse events	Arm 1	40	63
Total, other adverse events	Arm 2	18	18
Total, other adverse events	Arm 3	19	19
Total, other adverse events	Arm 4	25	30
Total, other adverse events	Arm 5	11	11

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32641862	DERIVED	PubMed
32692450	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01037790

GET https://conductscience.org/api/trials/v1/NCT01037790/events?page=2

API reference For AI assistants