Phase 1
N=46
A Dose Finding Study Of A New Medication, PF-00337210 That Will Possibly Decrease Blood Supply To Tumors
Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01105533 ↗Enrolled (actual)
46
Serious AEs
41.3%
Results posted
Mar 2013
Primary outcome: Primary: Number of Participants With Dose-limiting Toxicities (DLTs) — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-00337210 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Tolerated Dose (MTD) |
8 | — |
| PRIMARY Maximum Administered Dose (MAD) |
9 | — |
| PRIMARY Recommended Phase-2 Dose (RP2D) |
6 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
— | — |
| SECONDARY Plasma Decay Half-Life (t1/2) |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
— | — |
| SECONDARY Apparent Volume of Distribution (Vss) |
— | — |
| SECONDARY Systemic Clearance (CL) |
— | — |
| SECONDARY Number of Participants With Objective Response of Complete Response or Partial Response |
2 | — |
| SECONDARY Change From Baseline in Biomarkers at Day 1 of Each Cycle up to Cycle 25 |
— | — |
Summary
This study will test a new cancer medication to determine if this medication will block blood supply to a tumor and decrease growth of a tumor. This study will also define the safety profile and define the safest dose of this new medication for people who have cancer.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed advanced solid tumors un-responsive to currently available therapies or for which there is no standard therapy.
- At least 1 measurable disease site as defined by Response Evaluation Criterion in Solid Tumors [RECIST].
- Adequate bone marrow, liver function and renal function as defined by protocol.
- Blood pressure Requirements During dose escalation - no evidence of pre-existing hypertension and no antihypertensive medications at baseline.
During dose expansion - patient's whose hypertension is controlled by antihypertensive therapy.
Exclusion Criteria
- Chemotherapy, radiotherapy or any investigational therapy within 4 weeks of study entry
- Current use or anticipated need for drugs that are known CYP34 inhibitors or inducers.
- Patients with carcinomatous meningitis or un-treated brain metastases.
- Any acute cardiovascular incident within the past 12 months.
- Patients with active gastrointestinal bleeding or significant gastrointestinal abnormalities as defined by protocol
- Patients with no evidence of the following for 5 years: malignancy or metastatic disease of skin cancer (except melanoma), in situ cervical cancer or breast cancer or T1C prostate cancer.
Data sourced from ClinicalTrials.gov (NCT01105533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.