Trial Outcomes & Findings for AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer (NCT NCT00397878)

NCT ID: NCT00397878

Last Updated: 2019-08-20

Results Overview

Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Time from start of treatment to time of progression, up to 4 months

Results posted on

2019-08-20

Participant Flow

Recruitment Period: November 16, 2006 to April 08, 2008. Recruitment done at University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure
Treatment (Saracatinib)
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous
60 years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Region of Enrollment
United States
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: Time from start of treatment to time of progression, up to 4 months

Time period of metastatic colorectal patients with one previous chemotherapy treatment for metastatic disease who are alive and progression free after commencing the experimental therapy. A 95% posterior credible intervals used.

Outcome measures

Outcome measures
Measure
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Median Progression Free Survival (PFS)
7.9 weeks
Interval 2.1 to 9.6

SECONDARY outcome

Timeframe: Up to 5 years

Number of participants who survived up to 5 years

Outcome measures

Outcome measures
Measure
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Survival
6 Participants

SECONDARY outcome

Timeframe: within 54 days

Number of participants who progressed on treatment within less than or equal to 2 cycles (cycle=28 days; within 54 days PD).

Outcome measures

Outcome measures
Measure
Treatment (Saracatinib)
n=10 Participants
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Time to Progression
10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 weeks

Population: No patients consented to optional tissue analysis.

Statistical significance of the associations assessed using a nonparametric Sign Test performed on the difference of the post-treatment and pre-treatment values. A two-sided .05 significance level to be used.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Saracatinib)

Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment (Saracatinib)
n=10 participants at risk
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders
Abdominal pain
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Blood bilirubin increased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Death NOS
60.0%
6/10 • Number of events 10 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Dehydration
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Fatigue
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Fibrosis deep connective tissue
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypoalbuminemia
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypocalcemia
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hyponatremia
20.0%
2/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypophosphatemia
40.0%
4/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Respiratory, thoracic and mediastinal disorders
Lung Infection
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
Lymphocyte count decreased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Nausea
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Infections and infestations
Sepsis
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Small intestinal perforation
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
White blood cell decreased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.

Other adverse events

Other adverse events
Measure
Treatment (Saracatinib)
n=10 participants at risk
Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Hepatobiliary disorders
Alanine aminotransferase increased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Alkaline phosphatase increased
80.0%
8/10 • Number of events 12 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Anorexia
50.0%
5/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Hepatobiliary disorders
Aspartate aminotransferase increased
60.0%
6/10 • Number of events 7 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Diarrhea
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Respiratory, thoracic and mediastinal disorders
Dyspnea
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Abdominal distension
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Abdominal pain
60.0%
6/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Acidosis
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Skin and subcutaneous tissue disorders
Alopecia
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
Anemia
90.0%
9/10 • Number of events 12 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Psychiatric disorders
Anxiety
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Arthralgia
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Back Pain
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Hepatobiliary disorders
Blood bilirubin increased
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Cholesterol high
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Constipation
50.0%
5/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Creatine phosphokinase (CPK) increased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Creatinine increased
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Psychiatric disorders
Depression
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Respiratory, thoracic and mediastinal disorders
Epistaxis
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Extraocular muscle paresis
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Fatigue
100.0%
10/10 • Number of events 16 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Fever
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Flatulence
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Gastritis
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Headache
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hemoglobinuria
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Hemorrhoidal hemorrhage
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hyperglycemia
70.0%
7/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hyperkalemia
30.0%
3/10 • Number of events 4 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Cardiac disorders
Hypertension
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hyperuricemia
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypoalbuminemia
20.0%
2/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypocalcemia
30.0%
3/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypokalemia
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hyponatremia
20.0%
2/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Hypophosphatemia
60.0%
6/10 • Number of events 11 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Endocrine disorders
Hypothyroidism
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Immune system disorders
Immune system disorders
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Infections and infestations
Urinatry Tract Infections
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Psychiatric disorders
Insomnia
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Infections and infestations
Elevated Blood Counts (Investigations)
50.0%
5/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
Lymphocyte count decreased
10.0%
1/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Mucositis oral
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Myalgia
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Skin and subcutaneous tissue disorders
Nail loss
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Nausea
50.0%
5/10 • Number of events 8 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
Neutrophil count decreased
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Musculoskeletal and connective tissue disorders
Pain
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Nervous system disorders
Peripheral sensory neuropathy
70.0%
7/10 • Number of events 7 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
Platelet count decreased
40.0%
4/10 • Number of events 4 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Proctitis
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Metabolism and nutrition disorders
Proteinuria
50.0%
5/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Skin and subcutaneous tissue disorders
Rash acneiform
30.0%
3/10 • Number of events 5 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Rectal hemorrhage
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Respiratory, thoracic and mediastinal disorders
Repiratory, Running Nose
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
10.0%
1/10 • Number of events 1 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Tumor pain
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Renal and urinary disorders
Urinary frequency/retention
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Gastrointestinal disorders
Vomiting
30.0%
3/10 • Number of events 6 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Eye disorders
Watering eyes
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
General disorders
Weight loss
20.0%
2/10 • Number of events 2 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.
Blood and lymphatic system disorders
White blood cell decreased
10.0%
1/10 • Number of events 3 • Adverse events collected while participant was receiving treatment and up to 30 days after the last dose of treatment. Total study period was from January 10, 2007 to February 25, 2009.

Additional Information

Cathy Eng, MD / Professor

University of Texas MD Anderson Cancer Center

Phone: 713-792-2828

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60