Trial Outcomes & Findings for Docetaxel With or Without FGFR Inhibitor AZD4547 in Treating Patients With Recurrent Non-Small Cell Lung Cancer (NCT NCT01824901)

Last Updated: 2023-06-29

Results Overview

A total of 3 dose levels of AZD4547 were planned: 40mg (level 1), 60mg (level 2), and 80mg (level 3) in combination with a standard dose of docetaxel (75mg/m\^2). The starting dose level of AZD4547 was 40 mg. This portion of the study used a standard 3+3 design with patients enrolled in cohorts of 3. The plan was to recommend the maximum tolerated dose (MTD) as the dose level to be used in the phase II portion of the study. MTD is defined as the highest dose level at which less than or equal to 1 of 6 subjects experience dose limiting toxicity (DLT).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Assessed during cycle 1 (21 days)

Results posted on

2023-06-29

Participant Flow

This study opened to accrual on September 19, 2013, accrued its first patient on January 15, 2014, and was suspended to accrual on January 29, 2014 after each of the first two patients had been registered to the first dose level of the phase I and experienced DLTs. The study was subsequently closed on April 17, 2014 after having met the predefined criteria for closure per study design.

Participant milestones

Participant milestones
Measure	Phase I Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV AZD4547: Given PO	Arm I (Docetaxel; Phase II Step I) Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14. docetaxel: Given IV	Arm II (Docetaxel and AZD4547; Phase II Step I) Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. docetaxel: Given IV AZD4547: Given PO	Phase II Step II Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. AZD4547: Given PO
Overall Study STARTED	2	0	0	0
Overall Study COMPLETED	2	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Docetaxel With or Without FGFR Inhibitor AZD4547 in Treating Patients With Recurrent Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I n=2 Participants Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	66.5 years n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants

PRIMARY outcome

Timeframe: Assessed during cycle 1 (21 days)

Outcome measures

Outcome measures
Measure	Phase I n=2 Participants Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD) of FGFR Inhibitor AZD4547	NA mg As the first two patients experienced DLTs at the lowest dose level of the study, the MTD could not be identified and the study was then closed after having met the predefined criteria for closure per study design.

Adverse Events

Phase I

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I n=2 participants at risk Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Cardiac disorders Myocardial infarction	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Cardiac disorders Left ventricular systolic dysfunction	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
General disorders Multi-organ failure	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Gastrointestinal disorders Dysphagia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Gastrointestinal disorders Mucositis oral	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Infections and infestations Mucosal infection	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Lymphocyte count decreased	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Neutrophil count decreased	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations White blood cell decreased	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Nervous system disorders Somnolence	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Psychiatric disorders Confusion	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Respiratory, thoracic and mediastinal disorders Aspiration	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Vascular disorders Hypotension	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.

Other adverse events

Other adverse events
Measure	Phase I n=2 participants at risk Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
General disorders Fatigue	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
General disorders Fever	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
General disorders Edema limbs	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Gastrointestinal disorders Constipation	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Infections and infestations Mucosal infection	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Alanine aminotransferase increased	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Lymphocyte count decreased	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations Platelet count decreased	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Investigations White blood cell decreased	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypernatremia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypocalcemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hypomagnesemia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Metabolism and nutrition disorders Hyponatremia	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Nervous system disorders Peripheral sensory neuropathy	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.
Renal and urinary disorders Proteinuria	50.0% 1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Submission of late adverse events is required at follow-up visits up to 3 years.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60