Trial Outcomes & Findings for Phase II Study of ZD6474 in Advanced NSCLC (NCT NCT00290537)
NCT ID: NCT00290537
Last Updated: 2016-05-19
Results Overview
Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).
Results posted on
2016-05-19
Participant Flow
Recruitment Period: 01/19/2006 through 11/03/2006. All participants recruited at University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Part One: ZD6474
First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 every 3 weeks
|
Part Two: ZD6474 + Carboplatin + Paclitaxel
Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m\^2 IV over 3 hours on Day 1 every 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of ZD6474 in Advanced NSCLC
Baseline characteristics by cohort
| Measure |
ZD6474
n=4 Participants
Part One: three 3-week cycles 300 mg of ZD6474 daily.
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiologic evaluations performed after weeks 2 and 9 of treatment, then every 2 cycles or as indicated if progressive disease is suspected up to 6 cycles or 18 weeks (1 cycle = 3 weeks).Evaluate the response rate in patients receiving monotherapy with ZD6474 compared to ZD6474 plus carboplatin plus paclitaxel. No formal comparisons could be made and no conclusions drawn because of small numbers in the treatment groups; a result of an inability to fulfil the recruitment target.
Outcome measures
| Measure |
ZD6474
n=4 Participants
First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
|
ZD6474 + Carboplatin + Paclitaxel
Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
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|---|---|---|
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Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)
Complete Response
|
1 Participants
|
—
|
|
Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)
No Change/Stable Disease
|
1 Participants
|
—
|
|
Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)
Progressive Disease
|
1 Participants
|
—
|
|
Number of Participants With Response Following Treatment With 300 mg ZD6474 Daily (Study Part One)
Inevaluable for Response
|
1 Participants
|
—
|
Adverse Events
ZD6474
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ZD6474
n=4 participants at risk
Part One: three 3-week cycles 300 mg of ZD6474 daily.
|
|---|---|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Investigations
Alanine aminotransferase increased (ALT, SGPT)
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
ANOREXIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Investigations
Aspartate aminotransferase increased (AST, SGOT)
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
DIARRHEA
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
DRY MOUTH
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
General disorders
EDEMA: LIMB
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORM
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
General disorders
FATIGUE
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Investigations
HEMOGLOBIN INCREASED
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMON
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Blood and lymphatic system disorders
HEMORRHAGE/BLEEDIN
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Vascular disorders
HYPERTENSION
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
INCONTINENCE, ANAL
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Vascular disorders
LYMPHOPENIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
NAUSEA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
NAUSEA ALONE
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Eye disorders
VISION LOW
|
50.0%
2/4 • Number of events 2 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
PAIN (ABDOMEN NOS)
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Eye disorders
PAIN (EYE)
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Renal and urinary disorders
PROTEINURIA
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Gastrointestinal disorders
VOMITING
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
|
Investigations
WEIGHT LOSS
|
25.0%
1/4 • Number of events 1 • Adverse events collected through three 3-week cycles, then up to two weeks after treatment.
|
Additional Information
Vali Papadimitrakopoulou, MD / Associate Professor
U.T. M.D. Anderson Cancer Center
Phone: 713-792-6363
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place