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

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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 null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-rectal-cancer-xeloda-40fbbc7c
nct id: NCT01037790
trial label: Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 1
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
source section id
NCT01037790-om-0000
source outcome index
0
endpoint
Response Rates
endpoint definition
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 origin
10 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
arm key
OG000
arm label
Arm 1
regimen
Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01037790-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
arm key
OG001
arm label
Arm 2
regimen
Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01037790-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
arm key
OG002
arm label
Arm 3
regimen
Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01037790-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
arm key
OG003
arm label
Arm 4
regimen
Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01037790-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
outcome key
om-0000
arm key
OG004
arm label
Arm 5
regimen
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
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01037790-om-0000#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
harm key
EG000
source section id
NCT01037790-ae
event group key
EG000
event group label
Arm 1
serious affected
1
serious at risk
63
other affected
40
other at risk
63
frequency threshold
0
collection period
10years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
harm key
EG001
source section id
NCT01037790-ae
event group key
EG001
event group label
Arm 2
serious affected
10
serious at risk
18
other affected
18
other at risk
18
frequency threshold
0
collection period
10years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
harm key
EG002
source section id
NCT01037790-ae
event group key
EG002
event group label
Arm 3
serious affected
11
serious at risk
19
other affected
19
other at risk
19
frequency threshold
0
collection period
10years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
harm key
EG003
source section id
NCT01037790-ae
event group key
EG003
event group label
Arm 4
serious affected
10
serious at risk
30
other affected
25
other at risk
30
frequency threshold
0
collection period
10years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-rectal-cancer-xeloda-40fbbc7c
nct id
NCT01037790
harm key
EG004
source section id
NCT01037790-ae
event group key
EG004
event group label
Arm 5
serious affected
4
serious at risk
11
other affected
11
other at risk
11
frequency threshold
0
collection period
10years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice