CompletedNCT00171834Updated Feb 5, 2014Results posted

Dose Escalating Study of the Safety and Efficacy of Patupilone, q3w, in Patients With Non-small Cell Lung Cancer

A Phase 1/2 interventional study of Patupilone in Carcinoma, Non-Small-Cell Lung, sponsored by Novartis Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Novartis Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 89
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.

Conditions studied

Carcinoma, Non-Small-Cell Lung

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Keywords

EPO
EPO906
Brain metastasis
Lung cancer
Lung metastasis
NSCLC

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 89 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with histologic or cytologic confirmation of unresectable locally advanced or metastatic NSCLC (stage IIIB with pleural effusion only / stage IV) documented before first line therapy.
Prior treatment with a platinum-containing regimen
Age ≥18 years.
Performance status of 0-1 on the WHO scale.
Life expectancy of ≥3 months.
NSCLC patients should have at least one measurable lesion as defined by modified RECIST criteria. If the patient has had previous radiation to the marker lesion(s), the lesion must have demonstrated progression since the radiation.
NSCLC patients with controlled brain metastases are eligible to be enrolled in the brain metastases cohort at the MTD. "Controlled brain metastases" patients are defined as patients who are neurologically stable, i.e. have not experienced an increase in dose of steroidal or anticonvulsive therapy for at least 14 days prior to study entry.
Patients with brain metastases must be verified to have metastases secondary to NSCLC based on histology of primary and by temporal sequence of events (note: these patients are eligible even if lung disease is quiescent).
Patients with brain metastases must show evidence of residual disease or progression of disease since prior radiological or surgical therapy.
Patients with brain metastases should have at least one bidimensionally measurable intracranial lesion of minimum diameter 2 cm. Multifocal disease is permitted, but the eligibility of BM patients presenting with more than 6 intracranial lesions should be discussed with Novartis prior to enrolling the patient.
Patients with adequate hematologic parameters:
ANC ≥1.5 x 10\^9/L;
Hb ≥9.0 g/dL,
Platelet count ≥100 x 10\^9/L (untransfused).
Demonstrate the following blood chemistry laboratory values:
total bilirubin ≤ 1.5 x ULN;
AST/ALT ≤ 2.5 X ULN; (≤ 5 x ULN if hepatic metastasis is present)
alkaline phosphatase ≤ 2.5 x ULN; (≤ 5 x ULN if hepatic and/or bone metastasis are present)
serum creatinine \< 2 x ULN.
Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal).
All patients of reproductive potential must agree to use an effective method of contraception during the study and three months following termination of treatment.
All patients must use a barrier method for contraception for sexual intercourse or avoid this for the first 5 days after patupilone infusion.
Written informed consent must be obtained.

Exclusion criteria

Exclusion Criteria:

Patients who have received more than one prior chemotherapy regimen or any other systemic antineoplastic treatment including immunotherapy.
Patients who have received any investigational compound within the past 28 days or who are planning to receive other investigational drugs while participating in the study.
Patients with brain metastases who have received any prior chemotherapy regimen or any other systemic antineoplastic treatment for brain metastases.
Patients with brain metastases who have experienced a dose increase of 25% or more above previous dose, in concomitant steroidal or anticonvulsive therapy within 14 days prior to study entry.
Patients with brain metastases receiving steroidal or anticonvulsive therapy for whom a dose increase has been required within 14 days prior to start of study drug.
Patients with brain metastases who have leptomeningeal disease.
Patients with brain metastases who have extracranial metastases in more than two organs.
Patients with any peripheral polyneuropathy > Grade 1.
Patients with unresolved diarrhea > Grade 1.
Patients receiving hematopoietic growth factors except erythropoietin (refer Section 3.4.4).
Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease.
Patients taking warfarin or other agents containing warfarin, with the exception of low dose warfarin (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports.
Patients who have not recovered fully from surgery for any cause, including brain metastases patients who have had a biopsy or surgical resection of the brain tumor within 2 weeks prior to starting study drug or who are not fully recovered from any prior biopsy or surgical resection.
Patients who have received radiation therapy or chemotherapy within the last four weeks. Palliative radiotherapy of metastasis in extremities is allowed but such lesions cannot be used as tumor markers.
Patients with the presence of active or suspected acute or chronic uncontrolled infection, including abscess or fistulae.
Patients known to be HIV positive.
History of another malignancy within 3 years prior to study entry, except curatively treated non-melanotic skin cancer or cervical cancer in situ.
For patients enrolling in the brain metastases cohort, any of the following exclusions to MRI imaging:

Cardiac pacemaker Ferromagnetic metal implants other than those approved as safe for use in MRI scanners Claustrophobia Obesity (exceeding the limits of scanning equipment)

Pregnant or lactating females.
A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits.

Other protocol-dependent inclusion / exclusion criteria may apply

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 89 participants (actual)

Interventions

DrugPatupilone
Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.
Also known as: EPO906, Epothilone B

What researchers measure

Primary outcomes

Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m\^2 until MTD in steps of 0.5 mg/m\^2 until 12 mg/m\^2, then in steps of 1 mg/m\^2 till 13.0 mg/m\^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m\^2, thus, the MTD as defined by the protocol was not reached in this study.
Time frame: Cycle 1 (21 days)
Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator's assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.
Time frame: At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.

Secondary outcomes

Number of Participants With Best Overall Response-Phase I
This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.
Time frame: Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks
Overall Survival Time-Phase I and Phase II
Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).
Time frame: From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months
Time to Progression (TTP)-Phase I and Phase II
Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.
Time frame: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks
Duration of Stable Disease-Phase I and Phase II
Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.
Time frame: Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks
Time to Overall Response -Phase I and Phase II
Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).
Time frame: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks
Duration of Overall Response -Phase I and Phase II
Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.
Time frame: Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks

Results

Posted Jul 7, 2011

Participant flow

Participant flow — Overall Study
Milestone	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort
Started	6	12	12	12	8	35	4
Completed 6 cycles of treatment	0	0	1	0	2	1	0
Completed	0	0	0	0	0	0	0
Not completed	6	12	12	12	8	35	4
Withdrew: Adverse event	2	1	3	2	2	15	1
Withdrew: Withdrawal by subject	0	2	0	1	1	1	0
Withdrew: Death from study indication	0	1	0	0	1	0	0
Withdrew: Disease progression	4	8	8	9	2	18	3
Withdrew: Treatment duration completed	0	0	1	0	2	1	0

Outcome measures

SecondaryNumber of Participants With Best Overall Response-Phase I

This was defined as the number of participants whose best overall response was CR or PR by RECIST. Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.

Time frame:: Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks
Reported as:: Number · Participants

Number of Participants With Best Overall Response-Phase I
Participants	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)
Complete Response (CR)	0 ± 0	0 ± 0	0 ± 0	0 ± 0	0 ± 0
Partial Response (PR)	0 ± 0	3 ± 25	1 ± 8.3	1 ± 8.3	0 ± 0
Stable Disease (SD)	1 ± 16.7	2 ± 16.7	5 ± 41.7	4 ± 33.3	5 ± 62.5
Progressive Disease (PD)	5 ± 83.3	4 ± 33.3	5 ± 41.7	6 ± 50.0	1 ± 12.5
Unknown	0 ± 0	3 ± 25.0	1 ± 8.3	1 ± 8.3	2 ± 25.0
Best overall response (CR,PR) & the response rate	0 ± 0	3 ± 25.0	1 ± 8.3	1 ± 8.3	0 ± 0

SecondaryOverall Survival Time-Phase I and Phase II

Overall survival (OS) time was measured from the start of study drug to the date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact. Data was collected post treatment every 3 months until approximately 70% of patients have reached the survival endpoint (Phase I + Phase II).

Time frame:: From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months
Reported as:: Median · Months

Overall Survival Time-Phase I and Phase II
Months	Patupilone (EPO906) Phase I	Patupilone (EPO906) Phase II
Overall Survival Time-Phase I and Phase II	9.2 (6.8 to 12.9)	10.3 (6.0 to 13.6)

SecondaryTime to Progression (TTP)-Phase I and Phase II

Time to progression was measured from the start of study drug to the date of first documented disease progression by RECIST, discontinuation due to disease progression, or death from underlying cancer, whichever event occurred first. If a patient had not progressed by RECIST, discontinued due to disease progression, or died from underlying cancer, TTP was censored at the time of last adequate tumor assessment. However, if a patient took any new cancer therapy prior to PD or death, then TTP was censored at the date of last adequate tumor assessment prior to the start date of new cancer therapy.

Time frame:: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks
Reported as:: Median · Months

Time to Progression (TTP)-Phase I and Phase II
Months	Patupilone (EPO906) Phase I	Patupilone (EPO906) Phase II
Time to Progression (TTP)-Phase I and Phase II	2.1 (0.8 to 3.5)	2.1 (1.9 to 3.7)

PrimaryPhase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)

The MTD was defined as the highest dose of patupilone administered every three weeks (q3w) where not more than one out of six patients experienced a DLT using a standard 3+3 design. Dose escalation started at 6.5 mg/m\^2 until MTD in steps of 0.5 mg/m\^2 until 12 mg/m\^2, then in steps of 1 mg/m\^2 till 13.0 mg/m\^2. DLTs were assessed during cycle 1. During this time frame, no more than one DLT occurred in any of the explored dose levels up to 13 mg/m\^2, thus, the MTD as defined by the protocol was not reached in this study.

Time frame:: Cycle 1 (21 days)
Reported as:: Number · Dose Limiting Toxicity (DLT)

Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)
Dose Limiting Toxicity (DLT)	Patupilone 7.5 mg/m^2 (Phase I)	Patupilone 8.0 mg/m^2 (Phase I)	Patupilone 8.5 mg/m^2 (Phase I)	Patupilone 13.0 mg/m^2 (Phase I)
Asthenia	1	0	0	0
Diarrhea	0	1	1	1
Any DLT	1	1	1	1

PrimaryPhase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)

Overall response is the number of participants who had a complete response (CR) or a partial response (PR) based on local investigator's assessment of RECIST criteria. Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease (SD), small changes that do not meet previously given criteria.

Time frame:: At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks.
Reported as:: Number · Participants

Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Participants	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort
Complete Response	0 (6.596 to 30.55)
Partial Response (PR)	6
Stable Disease (SD)	9
Progressive Disease (PD)	13
Unknown	7
Best overall response (CR, PR) & the response rate	6

SecondaryDuration of Stable Disease-Phase I and Phase II

Duration of stable disease (CR, PR, or SD) by RECIST was defined as the time from start of study drug to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.

Time frame:: Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks
Reported as:: Median · Months

Duration of Stable Disease-Phase I and Phase II
Months	Patupilone (EPO906) Phase I	Patupilone (EPO906) Phase II
Duration of Stable Disease-Phase I and Phase II	3.7 (3.5 to 4.9)	5.6 (3.5 to 9.0)

SecondaryTime to Overall Response -Phase I and Phase II

Time to overall response (CR or PR) measured by RECIST was the time between study start until date of first documented response (CR or PR).

Time frame:: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks
Reported as:: Median · Months

Time to Overall Response -Phase I and Phase II
Months	Patupilone (EPO906) Phase I	Patupilone (EPO906) Phase II
Time to Overall Response -Phase I and Phase II	2.6 (1.2 to 3.5)	3.4 (1.0 to 6.5)

SecondaryDuration of Overall Response -Phase I and Phase II

Duration of overall response (CR or PR) measured by RECIST was measured from the first documented CR or PR to the date of first documented disease progression or discontinuation due to disease progression, or death from underlying cancer, whichever event occured first.

Time frame:: Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks
Reported as:: Median · Months

Duration of Overall Response -Phase I and Phase II
Months	Patupilone (EPO906) Phase I	Patupilone (EPO906) Phase II
Duration of Overall Response -Phase I and Phase II	2.6 (2.3 to 2.6)	NA (2.5 to NA)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Patupilone ≤7.0 mg/m^2 (Phase I)	—	3/6 (50%)	6/6 (100%)
Patupilone 7.5-8.0 mg/m^2 (Phase I)	—	3/12 (25%)	11/12 (91.7%)
Patupilone 8.5-9.5 mg/m^2 (Phase I)	—	2/12 (16.7%)	12/12 (100%)
Patupilone 10.0-11.5 mg/m^2 (Phase I)	—	3/12 (25%)	10/12 (83.3%)
Patupilone 12.0-13.0 mg/m^2 (Phase I)	—	4/8 (50%)	8/8 (100%)
Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	—	14/35 (40%)	33/35 (94.3%)
Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)	—	2/4 (50%)	4/4 (100%)

Most frequent serious events

Showing 10 of 24

Most frequent serious events
Event	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)
VomitingGastrointestinal disorders	0/6	1/12	0/12	0/12	0/8	0/35	1/4
FatigueGeneral disorders	0/6	0/12	0/12	0/12	0/8	0/35	1/4
Oedema peripheralGeneral disorders	0/6	0/12	0/12	0/12	0/8	0/35	1/4
DehydrationMetabolism and nutrition disorders	0/6	0/12	0/12	0/12	0/8	0/35	1/4
Confusional statePsychiatric disorders	0/6	0/12	0/12	0/12	0/8	0/35	1/4
DiarrhoeaGastrointestinal disorders	1/6	1/12	1/12	1/12	1/8	8/35	0/4
AstheniaGeneral disorders	1/6	0/12	0/12	0/12	1/8	1/35	0/4
Urinary tract infectionInfections and infestations	1/6	0/12	0/12	0/12	0/8	0/35	0/4
Peripheral sensorimotor neuropathyNervous system disorders	0/6	0/12	0/12	0/12	1/8	0/35	0/4
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/6	0/12	0/12	0/12	1/8	1/35	0/4

Most frequent other events

Showing 10 of 94

Most frequent other events
Event	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)
DiarrhoeaGastrointestinal disorders	3/6	6/12	9/12	7/12	7/8	29/35	4/4
Abdominal distensionGastrointestinal disorders	4/6	2/12	2/12	3/12	0/8	4/35	1/4
Abdominal painGastrointestinal disorders	3/6	5/12	3/12	4/12	0/8	10/35	1/4
NauseaGastrointestinal disorders	3/6	3/12	4/12	5/12	3/8	6/35	1/4
FatigueGeneral disorders	3/6	2/12	4/12	3/12	3/8	5/35	1/4
Decreased appetiteMetabolism and nutrition disorders	0/6	3/12	1/12	0/12	4/8	12/35	0/4
VomitingGastrointestinal disorders	1/6	4/12	5/12	3/12	3/8	12/35	1/4
ConstipationGastrointestinal disorders	1/6	2/12	1/12	2/12	3/8	1/35	1/4
ChillsGeneral disorders	0/6	1/12	2/12	3/12	3/8	3/35	0/4
ParaesthesiaNervous system disorders	2/6	1/12	3/12	3/12	2/8	8/35	1/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort	Total
Mean	58.3 ± 12.01	59.4 ± 8.98	57.8 ± 9.31	57.6 ± 9.07	56.3 ± 13.31	63.3 ± 8.04	60.5 ± 9.71	57.9 ± 9.85

Sex: Female, Male
Sex: Female, Male(Participants)	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort	Total
Female	3	5	4	4	2	10	2	30
Male	3	7	8	8	6	25	2	59

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Patupilone ≤7.0 mg/m^2 (Phase I)	Patupilone 7.5-8.0 mg/m^2 (Phase I)	Patupilone 8.5-9.5 mg/m^2 (Phase I)	Patupilone 10.0-11.5 mg/m^2 (Phase I)	Patupilone 12.0-13.0 mg/m^2 (Phase I)	Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort	Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort	Total
Caucasian	6	12	11	12	8	35	4	88
Black or African American	0	0	1	0	0	0	0	1

Study locations

4 sites

Norton Healthcare/Hospital Inc
Louisville, Kentucky 40232-5070, United States
Ellis Fisher Cancer Center
Columbia, Missouri 65203, United States
Hillman Cancer Center
Pittsburg, Pennsylvania 15232, United States
MD Anderson Cancer Center
Houston, Texas 77030-4009, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00171834
Lead sponsor: Novartis Pharmaceuticals
Responsible party: Sponsor
First posted: Sep 15, 2005
Start date: Aug 2003
Primary completion: Sep 2008
Completion: Sep 2008
Results posted: Jul 7, 2011
Last update: Feb 5, 2014

Study contacts

Novartis Pharmaceuticals

study director · Novartis Pharmaceuticals

View the source record on ClinicalTrials.gov ↗

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