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NCT01037790 · OUTCOME

Response Rates

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer · Source last updated 2021-03-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
10 years

What was measured

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)

Groups in this outcome

Arm 1

Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day

Arm 2

Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day

Arm 3

Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day

Arm 4

Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day

Arm 5

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm 163
Arm 218
Arm 319
Arm 430
Arm 511

Reported measurements

Source class 1

partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 14Not reportedNot reportedNot reportedNot reported
Arm 20Not reportedNot reportedNot reportedNot reported
Arm 30Not reportedNot reportedNot reportedNot reported
Arm 40Not reportedNot reportedNot reportedNot reported
Arm 50Not reportedNot reportedNot reportedNot reported

stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 132Not reportedNot reportedNot reportedNot reported
Arm 26Not reportedNot reportedNot reportedNot reported
Arm 36Not reportedNot reportedNot reportedNot reported
Arm 417Not reportedNot reportedNot reportedNot reported
Arm 53Not reportedNot reportedNot reportedNot reported

progressive disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 125Not reportedNot reportedNot reportedNot reported
Arm 28Not reportedNot reportedNot reportedNot reported
Arm 34Not reportedNot reportedNot reportedNot reported
Arm 49Not reportedNot reportedNot reportedNot reported
Arm 57Not reportedNot reportedNot reportedNot reported

not evaluable for response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 12Not reportedNot reportedNot reportedNot reported
Arm 24Not reportedNot reportedNot reportedNot reported
Arm 39Not reportedNot reportedNot reportedNot reported
Arm 44Not reportedNot reportedNot reportedNot reported
Arm 51Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      title
      partial response
    2. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        17
      5. group Id
        OG004
        value
        3
      title
      stable disease
    3. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        7
      title
      progressive disease
    4. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        9
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      title
      not evaluable for response
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      19
    4. group Id
      OG003
      value
      30
    5. group Id
      OG004
      value
      11
    units
    Participants
description
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)
groups
  1. description
    Metastatic breast cancer PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    OG000
    title
    Arm 1
  2. description
    Metastatic colorectal cancer that harbors the Kras or BRAF mutation PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    OG001
    title
    Arm 2
  3. description
    Advanced or metastatic esophageal and/or gastric cancer PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    OG002
    title
    Arm 3
  4. description
    Cisplatin-refractory, unresectable germ cell tumors PD-0332991: Given orally, 125 mg QD on a 21-day
    id
    OG003
    title
    Arm 4
  5. description
    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
    id
    OG004
    title
    Arm 5
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
10 years
title
Response Rates
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice